Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 12, 2018 | Jun. 30, 2017 | |
Document Information [Line Items] | |||
Entity Registrant Name | BioCardia, Inc. | ||
Entity Central Index Key | 925,741 | ||
Trading Symbol | bcda | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding (in shares) | 38,241,592 | ||
Entity Public Float | $ 147,668,470 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 12,689 | $ 21,352 |
Accounts receivable, net of allowance for doubtful accounts of $6 and $2 at December 31, 2017 and 2016, respectively | 95 | 74 |
Inventory | 191 | 135 |
Prepaid expenses | 340 | 356 |
Total current assets | 13,315 | 21,917 |
Property and equipment, net | 169 | 111 |
Other assets | 54 | 54 |
Total assets | 13,538 | 22,082 |
Current liabilities: | ||
Accounts payable | 902 | 525 |
Accrued expenses and other current liabilities | 1,263 | 848 |
Deferred revenue | 167 | 71 |
Total current liabilities | 2,332 | 1,444 |
Deferred rent | 81 | 56 |
Total liabilities | 2,413 | 1,500 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 25,000,000 and 50,000,000 shares authorized as of December 31, 2017 and 2016, respectively; no shares issued and outstanding as of December 31, 2017 and 2016 | 0 | 0 |
Common stock, $0.001 par value, 100,000,000 and 750,000,000 shares authorized as of December 31, 2017 and 2016 respectively; 38,218,660 and 38,131,303 shares issued and outstanding as of December 31, 2017 and 2016, respectively | 38 | 38 |
Additional paid-in capital | 83,537 | 80,686 |
Accumulated deficit | (72,450) | (60,142) |
Total stockholders’ equity | 11,125 | 20,582 |
Total liabilities and stockholders’ equity | $ 13,538 | $ 22,082 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Allowance for doubtful accounts | $ 6 | $ 2 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 50,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 750,000,000 |
Common stock, shares issued (in shares) | 38,218,660 | 38,131,303 |
Common stock, shares outstanding (in shares) | 38,218,660 | 38,131,303 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue: | |||
Net product revenue | $ 389,000 | $ 517,000 | $ 860,000 |
Collaboration agreement revenue | 90,000 | 59,000 | 44,000 |
Total revenue | 479,000 | 576,000 | 904,000 |
Costs and expenses: | |||
Cost of goods sold | 690,000 | 746,000 | 1,061,000 |
Research and development | 5,799,000 | 3,330,000 | 1,518,000 |
Selling, general and administrative | 6,395,000 | 4,108,000 | 3,734,000 |
Total costs and expenses | 12,884,000 | 8,184,000 | 6,313,000 |
Operating loss | (12,405,000) | (7,608,000) | (5,409,000) |
Other income (expense): | |||
Interest income | 95,000 | ||
Interest expense | 0 | (1,736,000) | (1,386,000) |
Write-off of deferred offering costs | (1,634,000) | ||
Change in fair value of convertible preferred stock warrant liability | 250,000 | 274,000 | |
Change in fair value of maturity date preferred stock warrant liability | 10,000 | 87,000 | |
Change in fair value of convertible shareholder notes derivative liability | (1,224,000) | 1,373,000 | |
Other income (expense) | 2,000 | (2,000) | (2,000) |
Total other income (expense), net | 97,000 | (2,702,000) | (1,288,000) |
Net loss | $ (12,308,000) | $ (10,310,000) | $ (6,697,000) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.32) | $ (1.23) | $ (4.29) |
Weighted-average shares used in computing net loss per share, basic and diluted (in shares) | 38,160,543 | 8,368,284 | 1,560,293 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Preferred Stock [Member]Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2014 | 98,354,541 | 1,541,169 | |||
Balance at Dec. 31, 2014 | $ 38,213 | ||||
Balance at Dec. 31, 2014 | $ 2 | $ 16 | $ (43,135) | $ (43,117) | |
Reclassification from temporary equity to permanent equity (in shares) | (98,354,541) | ||||
Reclassification from temporary equity to permanent equity | $ (38,213) | ||||
Permanent equity, reclassified from temporary equity (in shares) | 98,354,541 | ||||
Permanent equity, reclassified from temporary equity | $ 38,213 | 38,213 | |||
Conversion of convertible notes (in shares) | 12,075,610 | ||||
Conversion of convertible notes | $ 7,781 | 7,781 | |||
Exercise of convertible preferred stock warrants for series D preferred shares (in shares) | 67,884 | ||||
Exercise of convertible preferred stock warrants for series D preferred shares | $ 34 | 34 | |||
Exercise of convertible preferred stock warrants for series F preferred shares (in shares) | 2,479 | ||||
Exercise of convertible preferred stock warrants for series F preferred shares | $ 2 | 2 | |||
Exercise of stock options (in shares) | 37,793 | ||||
Exercise of stock options | 59 | 59 | |||
Stock-based compensation | 283 | 283 | |||
Net loss | (6,697) | (6,697) | |||
Balance (in shares) at Dec. 31, 2015 | 110,500,514 | 1,578,962 | |||
Balance at Dec. 31, 2015 | $ 46,030 | $ 2 | 358 | (49,832) | (3,442) |
Conversion of convertible notes (in shares) | 8,091,103 | ||||
Conversion of convertible notes | $ 8 | 12,148 | 12,156 | ||
Exercise of stock options (in shares) | 13,460 | ||||
Exercise of stock options | 22 | 22 | |||
Stock-based compensation | 942 | 942 | |||
Net loss | (10,310) | (10,310) | |||
Exchange of convertible preferred stock warrants to common stock (in shares) | 10,807 | ||||
Exchange of convertible preferred stock warrants to common stock | 25 | 25 | |||
Reclassification of convertible shareholder notes derivative liability | 2,268 | 2,268 | |||
Conversion of preferred stock into common stock (in shares) | (110,500,514) | 9,208,376 | |||
Conversion of preferred stock into common stock | $ (46,030) | $ 9 | 46,021 | ||
Issuance of common stock upon reverse merger (in shares) | 19,228,595 | ||||
Issuance of common stock upon reverse merger | $ 19 | 18,902 | 18,921 | ||
Balance (in shares) at Dec. 31, 2016 | 38,131,303 | ||||
Balance at Dec. 31, 2016 | $ 38 | 80,686 | (60,142) | $ 20,582 | |
Exercise of stock options (in shares) | 87,357 | 87,542 | |||
Exercise of stock options | 144 | $ 144 | |||
Stock-based compensation | 2,707 | 2,707 | |||
Net loss | (12,308) | (12,308) | |||
Balance (in shares) at Dec. 31, 2017 | 38,218,660 | ||||
Balance at Dec. 31, 2017 | $ 38 | $ 83,537 | $ (72,450) | $ 11,125 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating activities: | |||
Net loss | $ (12,308) | $ (10,310) | $ (6,697) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Write-off of inventory | 597 | ||
Depreciation and amortization | 78 | 39 | 47 |
Change in fair value of convertible preferred stock warrant liability | (250) | (274) | |
Change in fair value of maturity date preferred stock warrant liability | (10) | (87) | |
Change in fair value of convertible shareholder notes derivative liability | 1,224 | (1,373) | |
Share-based compensation | 2,707 | 942 | 283 |
Non-cash interest expense on convertible shareholder notes | 1,736 | 1,387 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (21) | 33 | 65 |
Inventory | (56) | 27 | (82) |
Prepaid expenses and other current assets | 16 | (110) | (129) |
Deferred financing costs | 48 | ||
Other assets | (11) | ||
Accounts payable | 377 | (17) | 228 |
Accrued liabilities excluding accrued interest on convertible note | 415 | 530 | (416) |
Deferred revenue | 96 | 32 | |
Deferred rent | 25 | 26 | (23) |
Net cash used in operating activities | (8,671) | (5,522) | (7,023) |
Investing activities: | |||
Purchase of property and equipment | (136) | (125) | |
Cash acquired in reverse merger | 19,017 | ||
Payment of transaction costs of reverse merger | (96) | ||
Purchase of short-term investments | (1,800) | ||
Maturity of short-term investments | 1,800 | ||
Net provided by (used in) in investing activities | (136) | 18,921 | (125) |
Financing activities: | |||
Proceeds from the exercise of convertible preferred stock warrants | 27 | ||
Proceeds from issuance of convertible notes and warrants | 4,374 | 7,435 | |
Proceeds from the exercise of common stock options | 144 | 22 | 59 |
Net cash provided by financing activities | 144 | 4,396 | 7,521 |
Net increase (decrease) in cash and cash equivalents | (8,663) | 17,795 | 373 |
Cash and cash equivalents at beginning of period | 21,352 | 3,557 | 3,184 |
Cash and cash equivalents at end of period | 12,689 | 21,352 | 3,557 |
Supplemental disclosure of noncash investing and financing activities: | |||
Exchange of convertible preferred stock warrants for common stock | 25 | ||
Conversion of convertible shareholder notes and related interest payable | 12,156 | 7,781 | |
Reclassification of convertible shareholder notes derivative liability | 2,268 | ||
Conversion of preferred stock | $ 46,030 |
Note 1 - Summary of Business
Note 1 - Summary of Business | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | ( 1 Summary of Business (a) Description of Business BioCardia, Inc., or the Company, is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Its lead therapeutic candidate is the CardiAMP cell therapy system and its second The Company has three 1 2 3 (b) Reverse Stock Split On or about September 25, 2017, 63.6% ’s Board of Directors to approve a 12 1 November 3, 2017. Following the Reverse Stock Split, certain reclassifications have been made to the prior periods ’ financial statements to conform to the current period's presentation. The Company adjusted stockholders’ equity to reflect the Reverse Stock Split by reclassifying an amount equal to the par value of the shares eliminated by the split from common stock to the additional paid-in capital for all periods presented in these consolidated financial statements, resulting in no As of December 31, 2016, ’s authorized share capital was 750 50 November 3, 2017, 100 25 December 31, 2017. ( c ) Reverse Merger On August 22, 2016, October 24, 2016, 54% Exchange Ratio Pursuant to the Merger Agreement, each share of BioCardia Lifesciences common stock issued and outstanding prior to the Merger, including shares of common stock underlying outstanding preferred stock, convertible notes (which converted into common stock immediately prior to the Merger), and stock options were converted into the right to receive 1.6139834 |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | ( 2 Significant Accounting Policies (a) Basis of Presentation and Consolidation These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all adjustments necessary for the fair presentation of the Company ’s financial position for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All material intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. (b) Liquidity - Going Concern The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $72.5 December 31, 2017. st the next several years. The Company expects to incur increasing costs as the pivotal CardiAMP Heart Failure trial is advanced and development of the CardiAMP and CardiALLO Cell Therapy Systems continue. Therefore absent additional funding, management believes cash and cash equivalents of $12.7 December 31, 2017 not fourth 2018. one not The Company ’s ability to continue as a going concern and to continue further development of its therapeutic candidates through and beyond the fourth 2018, not not may may (c) Use of Estimates The preparation of the financial statements in accordance with U.S. GAAP requires Company management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include the useful lives of property and equipment; allowances for doubtful accounts and sales returns; inventory valuation; fair value of the convertible preferred stock warrant liability; fair value of the maturity date preferred stock warrant liability; fair value of the convertible shareholder notes derivative liabilit y; and share-based compensation. (d) Cash Equivalents The Company classifies all highly liquid investments with original maturities of three months or less at the date of purchase as cash equivalents. The Company maintains its cash and cash equivalents with reputable financial institutions. (e) Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company maintains its cash at financial institutions, which at times, exceed federally insured limits. At December 31, 2017, one not not (f) Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not not ’s historical write-off experience, customer creditworthiness, facts and circumstances specific to outstanding balances and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts was $6,000 $2,000 December 31, 2017 2016, (g) Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the average-cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company analyzes its inventory levels quarterly and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of and the related costs are recognized in cost of goods sold. (h) Deferred Financing Costs Deferred financing costs represent direct costs associated with future issuances of our corporate securities. Direct costs include, but are not not , which was delayed and subsequently withdrawn. The deferred offering costs for that offering in the amount of $1,634,000 2015. (i) Property and Equipment, Net Property and equipment, net are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, as described in the table below. Maintenance and repairs are expensed as incurred. When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the accompanying consolidated statements of operations. Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 years or lease term, if shorter (j) Long-Lived Assets The Company evaluates long-lived assets such as property and equipment whenever events or changes in circumstances indicate the carrying amount of an asset may not not ’s carrying amount, the asset is written down to its fair value. There have been no (k) Clinical Trial Accruals As part of the process of preparing its consolidated financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiation and may not ’s objective is to reflect the clinical trial expenses in its consolidated financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company makes estimates of its accrued expenses as of each balance sheet date in its consolidated financial statements based on the facts and circumstances known at that time. Although, the Company does not may may (l) Derivatives Fair value accounting requires bifurcation of embedded derivative instruments such as conversion features in equity instruments and warrants granted, and measurement of their fair value. In determining the appropriate fair value of the compound embedded derivative requiring bifurcation from the convertible notes issued in 2015, three (m) Deferred Rent The Company ’s lease for its facility provides for fixed increases in minimum annual rental payments. The total amount of rental payments due over the lease term is charged to rent expense ratably over the life of the lease. Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight-line basis. (n) Revenue Recognition The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred, the price to the buyer is fixed or determinable, and collection from the customer is reasonably assured. Net product revenue – The Company currently has a portfolio of enabling and delivery products. The Company recognizes revenue from product sales when title and risk of loss have passed to the customer, which typically occurs upon delivery. Product sale transactions are evidenced by customer purchase orders, customer contracts, invoices and/or related shipping documents. Revenue is recognized net of provisions made for discounts, expected sales returns and allowances. Estimated returns and allowances are based on historical experience and other relevant factors. The Company accepts returns for unused, unopened and resellable product in its original packaging, subject to a restocking fee. The sales return reserve was approximately $ 1,000 December 31, 2017 2016. Amounts received from customers in advance of revenue recognition are recorded as deferred revenue on the consolidated balance sheets. Collaboration agreement revenue two ● The delivered items have value to the customer on a stand-alone basis ● If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company ’s control Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the customer could use the delivered item for its intended purpose without receipt of the remaining deliverables. If an arrangement includes multiple deliverables that are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting based on their relative selling prices and recognizes the associated revenue when the appropriate recognition criteria are met for those deliverables. The amount of allocable arrangement consideration is limited to the amounts that are fixed and determinable. (o) Shipping Costs Costs incurred for the shipping of products to customers totaled approximately $5,000, $7,000 $11,000 December 31, 2017, 2016 2015, (p) Product Warranties The Company provides a standard warranty of serviceability on all its products for the duration of the product ’s shelf life, which is two not December 31, 2017 2016. (q) Research and Development The Company ’s research and development costs are expensed as incurred. Research and development expense includes the costs of basic research activities as well as other research, engineering, and technical effort required to develop new products or services or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses and support costs for collaborative partnering programs wherein the Company provides biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. The Company’s research and development costs consist primarily of: ● Salaries, benefits and other personnel-related expenses, including share-based compensation ● Fees paid for services provided by clinical research organizations, research institutions, consultants and other outside service providers ● Costs to acquire and manufacture materials used in research and development activities and clinical trials ● Laboratory consumables and supplies ● Facility-related expenses allocated to research and development activities ● Fees to collaborators to license technology ● Depreciation expense for equipment used for research and development and clinical purposes. (r) Share-Based Compensation The Company measures and recognizes share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. The Company uses the Black-Scholes option pricing model to calculate fair value. Share-based compensation expense recognized in the consolidated statements of operations is based on the period the services are performed. The Company accounts for forfeitures as they occur. For options granted to nonemployees, the Company revalues the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the consolidated statements of operations over the period the related services are rendered. The Black-Scholes option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our share-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate The risk free interest rate assumption is based on the zero Expected Volatility The Company has limited historical data of its own to utilize in determining expected volatility. As such we based our volatility assumption on a combined weighted average of our own historical data and that of a selected peer group. The peer group was developed based on companies in the biotechnology and medical device industries whose shares are publicly-traded. Expected Term The expected term represents the period of time that options are expected to be outstanding. As the Company does not Common Stock Valuation Prior to the completion of the Merger, due to the absence of a public market for the BioCardia Lifesciences common stock, it was necessary to estimate the fair value of the common stock underlying the share-based awards when performing fair value calculations using the BSM option pricing model. The fair value of the common stock underlying the share-based awards was assessed on each grant date by the board of directors of BioCardia Lifesciences. All options to purchase shares of the Company’s common stock have been granted with an exercise price per share no (s) Income Taxes The Company accounts for income taxes based on the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets, liabilities, operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not not In evaluating the ability to recover its deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, forecasts of future taxable income, and ongoing tax planning. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, it would make an adjustment to the valuation allowance, which would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not The Company recognizes and measures benefits for uncertain tax positions using a two first not not second 50% ’s policy is to recognize interest and penalties related to unrecognized tax benefits as a component of income tax expense in the consolidated statements of operations and accrued interest and penalties within accrued liabilities in the consolidated balance sheets. No (t) Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the consolidated financial statements. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Where observable prices or inputs are not The Company ’s financial assets and liabilities consist principally of cash and cash equivalents, accounts receivable, accounts payable, warrants for convertible preferred stock, convertible notes and the convertible shareholder notes derivative liability. The fair value of the Company’s cash equivalents is determined based on quoted prices in active markets for identical assets. The recorded values of the Company’s accounts receivable and accounts payable approximate their current fair values due to the relatively short-term nature of these accounts. The fair value of the Company’s convertible preferred stock warrants is measured using the Black-Scholes option pricing model. Convertible notes are recorded at amortized cost. The fair value of the Company’s convertible shareholder notes derivative liability is measured utilizing a Monte Carlo simulation model. Based on borrowing rates currently available for loans with similar terms, the carrying value of convertible notes approximates fair value. (u) Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of convertible preferred stock, notes convertible into preferred stock, warrants to purchase convertible preferred stock and options outstanding under our stock option plans. For all periods presented, there is no (v) Recently Adopted Accounting Pronouncements In March 2016, No. 2016 09, 718 2016 09 2016 09 January 1, 2017. The impact of adopting ASU 2016 09 ● We classified the excess income tax benefits from stock-based compensation arrangement as a discrete item within income tax expense, rather than recognizing such excess income tax benefits in additional paid-in capital. The adoption of this guidance had no . ● We elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this guidance on a modified retrospective basis was insignificant . ● We applied the change in classification of cash flows resulting from excess tax benefits and cash paid by us when directly withholding shares for tax-withholding purposes on a retrospective basis. The adoption of these provisions did not There were no (w) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 . In August 2015, No. 2015 14 December 15, 2017. not ’s customer contracts and the potential impacts the standard may January 1, 2018 not In January 2016, No. 2016 01 2016 01 2016 01 ’s fiscal year beginning January 1, 2018 not no may 2016 01 January 1, 2018 not In February 2016, No. 2016 02 842 840 2016 02 December 15, 2018; not 2016 02 In May 2017, No. 2017 09 – Stock Compensation (Topic 718 2017 09 718. 2016 01 January 1, 2018 not Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not not ’s financial statement presentation or disclosures. |
Note 3 - Reverse Merger
Note 3 - Reverse Merger | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Assets Acquired Through Merger [Text Block] | ( 3 Reverse Merger On October 24, 2016, 1. For financial reporting purposes, the Merger is accounted for as an asset acquisition by BioCardia Lifesciences rather than a business combination because we did not $19 No $96,000 The Merger is considered a tax free reverse triangular merger for tax purposes pursuant to Internal Revenue Code Sections 368 368 2 Despite the stock acquisition treatment, none 382 |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | ( 4 Fair Value Measurements The fair value of financial instruments reflects the amounts that the Company estimates to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). The Company follows a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels: Level 1 Level 2 not Level 3 no The following table sets forth the fair value of our financial assets measured on a recurring basis as of December 31, 2017 December 31, 2016 As of December 31, 201 7 Level 1 Level 2 Level 3 Tota l Assets : Cash and cash equivalent s $ 12,689 $ — $ — $ 12,689 As of December 31, 201 6 Level 1 Level 2 Level 3 Tota l Assets : Cash and cash equivalent s $ 21,352 $ — $ — $ 21,352 |
Note 5 - Inventories
Note 5 - Inventories | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | ( 5 Inventories Inventories are stated at the lower of cost or net realizable value using the average cost method. Inventories consist of the following (in thousands): December 31, 201 7 201 6 Raw material s $ 70 $ 59 Work in proces s 92 — Finished good s 29 76 Tota l $ 191 $ 135 Write downs for excess or expired inventory are based on management ’s estimates of forecasted usage of inventories and are included in cost of goods sold. A significant change in the timing or level of demand for certain products as compared to forecasted amounts may $33,000, $52,000 $261,000 December 31, 2017, 2016 2015, |
Note 6 - Property and Equipment
Note 6 - Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | ( 6 ) Property and Equipment, Net Property and equipment, net consist of the following (in thousands): December 31, 201 7 201 6 Computer equipment and softwar e $ 106 143 Laboratory and manufacturing equipmen t 447 366 Furniture and fixture s 48 48 Leasehold improvement s 326 325 Property and equipment, gros s 927 882 Less accumulated depreciatio n (758 ) (771 ) Property and equipment, ne t $ 169 111 Depreciation expense totaled approximately $78,000, $39,000 $47,000 December 31, 2017, 2016 2015, |
Note 7 - Commitments
Note 7 - Commitments | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Commitments Disclosure [Text Block] | ( 7 ) Commitments In November 2016, 60 d on January 1, 2017 December 31, 2021. $601,000, $321,000 $266,000 December 31, 2017, 2016 2015, December 31, 2017 Years ending December 31 : 201 8 $ 594 201 9 612 202 0 630 202 1 649 Tota l $ 2,485 |
Note 8 - Collaborative Agreemen
Note 8 - Collaborative Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | ( 8 ) Collaborative Agreements The Company has entered into various collaborations related to clinical development. These agreements allow partners to utilize the Company ’s enabling biotherapeutic delivery systems, including training and support during clinical and pre-clinical delivery of biotherapeutics. Under the terms of these agreements, the Company typically receives a use fee and payments for the systems and services provided. The Company gains access to certain data generated by its partners for use in its own product development efforts and also receives nonexclusive patent rights to any BioCardia technology improvement inventions. |
Note 9 - Accrued Expenses and O
Note 9 - Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Accrued Liabilities and Other Current Liabilities Disclosure [Text Block] | ( 9 ) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 201 7 201 6 Accrued expense s $ 539 $ 478 Grant liabilit y 663 304 Customer deposit s 61 66 Tota l $ 1,263 $ 848 |
Note 10 - Convertible Preferred
Note 10 - Convertible Preferred Stock Warrant Liability | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Convertible Preferred Stock Warrant [Text Block] | ( 10 ) Convertible Preferred Stock Warrant Liability The Company has historically issued warrants to purchase shares of the Company ’s preferred stock in connection with certain preferred stock offerings and note financings. Upon the completion of the Merger in October 2016, 20% 10% 6,788 4,019 $25,000, |
Note 11 - Convertible Notes
Note 11 - Convertible Notes | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | ( 11 ) Convertible Notes In May 2015, $7.2 2015 8% 18 2015 5,620,332 In October 2016, BioCardia Lifesciences issued convertible notes with an aggregate principle amount of approximately $4.4 8% 2,470,771 The Company recognized interest expense, including amortization of the debt discount of approximately zero , $1.7 $1.4 December 31, 2017, 2016 2015, |
Note 12 - Convertible Preferred
Note 12 - Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Preferred Stock [Text Block] | ( 12 ) Convertible Preferred Stock Upon the completion of the Merger, convertible preferred stock converted into 9,208,376 |
Note 13 - Share-based Compensat
Note 13 - Share-based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | ( 13 ) Share-Based Compensation BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2002 2002 “2002 2002 have not not 2002 2016, 2016 “2016 2016 2016 2002 2016 four ten no The Company recognizes in the consolidated statements of operations the grant-date fair value of stock options and other equity-based compensation. Share-based compensation expense for the years ended December 31, 2017, 2016 2015 Years ended December 31 , 201 7 201 6 201 5 Cost of goods sol d $ 140 $ 14 $ 4 Research and developmen t 678 127 29 Selling, general and administrativ e 1,889 801 250 Share-based compensation expens e $ 2,707 $ 942 $ 283 The following table summarizes activity under the Company’s stock option plans, including the 2002 2016 Options outstanding Weighted Weighted Aggregate average average intrinsic Number of exercise remaining contractual value shares price term (years) (in thousands) Balance, December 31, 2016 3,491,937 $ 1.78 8.7 $ 39,046 Stock options granted 842,653 7.66 Stock options exercised ( ) 1.87 Stock options cancelled ( ) 0.48 Balance, December 31, 2017 4,213,100 $ 2.96 8.1 $ 1,890 Exercisable, December 31, 2017 1,556,234 $ 2.28 6.9 $ 844 Unexercisable, December 31, 2017 2,656,866 $ 3.36 8.8 $ 1,046 The total intrinsic value of options exercised during the years ended December 31, 2017, 2016 2015 $400,000, $144,000 $137,000, December 31, 2017 2016 $5.8 $1.33 Employee Share-Based Compensation During the year s ended December 31, 2017 2016, to purchase 796,399 2,190,629 no December 31, 2015. option pricing model with the following assumptions: Years ended December 31 , 201 7 201 6 Risk-free interest rat e 1.76 - 2.25% 1.28 - 1.58% Volatilit y 81 - 89% 88% Dividend yiel d None None Expected term (in years ) 5.00 - 6.25 6.25 Unrecognized share-based compensation for non-employee directors and employee options granted through December 31, 2017 $4.9 2.8 Non-Employee Director Share-Based Compensation (RSUs) During the year ended December 31, 2017, 97,996 The following summarizes the activity of non-vested RSUs: Weighte d averag e grant dat e Number o f fair valu e share s per shar e Balance, December 31, 201 6 — RSUs grante d 97,996 $ 8.71 RSUs veste d — RSUs forfeite d — Balance, December 31, 201 7 97,996 $ 8.71 Unrecognized share-based compensation for employee RSUs granted through December 31, 2017 $541,000 1.8 Nonemployee Share-Based Compensation During the year ended December 31, 201 7 2016, 46,254 490,849 No December 31, 2015. $768,000, $545,000 $10,000 December 31, 2017, 2016 2015 The Company accounts for share-based compensation arrangements with nonemployees, using the B lack Scholes option pricing model, based on the fair value as these instruments vest. Accordingly, at each reporting date, the Company revalues the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the consolidated statements of operations over the period the related services are rendered. The following assumptions were used to value the awards. Years ended December 31 , 201 7 201 6 201 5 Risk-free interest rate 2.25 - 2.40% 1.60 - 2.42% 1.26 - 2.30% Volatility 81 - 87% 89 - 91% 71 - 95% Dividend yield None None None Expected term (in years) 8.6 - 9.8 9.6 - 9.9 8.5 - 9.7 |
Note 14 - Concentrations
Note 14 - Concentrations | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Concentration Risk Disclosure [Text Block] | ( 14 ) Concentrations Most of the Company’s customers are located in the United States. No 10% 2017, 2016 2015 one 20% December 31, 2017 29% December 31, 2016. |
Note 15 - Net Loss Per Share
Note 15 - Net Loss Per Share | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | ( 15 ) Net Loss per Share The following table sets forth the computation of the basic and diluted net loss per share for the years ended December 31, 2017, 2016 2015 Years ended December 31 , 201 7 201 6 201 5 Numerator : Net los s $ (12,308 ) $ (10,310 ) $ (6,697 ) Denominator : Weighted average shares used to compute net loss per share, basic and dilute d 38,160,543 8,368,284 1,560,293 Net loss per share, basic and diluted $ (0.32 ) $ (1.23 ) $ (4.29 ) The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: December 31 , 201 7 201 6 201 5 Convertible preferred stoc k - - 9,208,376 Notes convertible into share s - - 8,731,657 Convertible preferred stock warrant s - - 194,383 Stock options to purchase common stoc k 4,213,100 3,491,937 1,149,040 Unvested restricted stock unit s 97,996 - - Tota l 4,311,096 3,491,937 19,283,456 |
Note 16 - Income Taxes
Note 16 - Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | ( 16 ) Income Taxes The Company ’s provision for income taxes for the years ended December 31, 2017, 2016 2015 $0 The provision for income taxes differs from the amount which would result by applying the federal statutory income tax rate to pre-tax loss for the years ended December 31, 2017, 2016 2015. Years ended December 31 , 201 7 201 6 201 5 Tax at federal statutory rat e $ (4,185 ) $ (3,505 ) $ (2,277 ) State, net of federal benefi t (1,238 ) (315 ) (335 ) Research and development credi t (135 ) (89 ) (51 ) Stock-based compensatio n 344 136 89 Nondeductible interes t — 590 471 Warrant and derivative revaluatio n — 328 (589 ) Change in Federal tax rat e 8,172 — — Othe r 7 94 5 Change in valuation allowanc e (2,965 ) 2,761 2,687 Total provision for income taxe s $ — $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss and tax credit carryforwards, net of any adjustment for unrecognized tax benefits. The components of the net deferred income tax assets as of December 31, 2017 2016 December 31 , 201 7 201 6 Accrued compensatio n $ 110 $ 154 Inventory adjustment s 449 708 Depreciation and amortization - noncurren t 146 252 Share-based compensatio n 558 273 Net operating loss and tax credit carryforwards - noncurren t 17,368 20,196 Othe r 34 47 Gross deferred tax asse t 18,665 21,630 Valuation allowanc e (18,665 ) (21,630 ) Net deferred tax asse t $ — $ — The Company has approximately $57.6 $47.7 December 31, 2017. 2022 2028 may may may one not 50% three Generally, utilization of the net operating loss carryforwards and credits may 382, 383, 1986, may The Company has not 382 At December 31, 201 7, $1.6 $1.3 2028. no The Company does not not not December 31, 2017 2016. The net decrease in the total valuation allowance for the year ended December 31, 2017 $3.0 December 31, 2016 $2.8 No The aggregate changes in the balance of gross unrecognized tax benefits were as follows (in thousands): December 31 , 201 7 201 6 Balance, beginning of yea r $ 608 $ 531 Additions based on tax positions related to the current yea r 117 77 Additions (reductions) for tax positions related to prior year s — — Balance, end of yea r $ 725 $ 608 Recognition of approximately $ 511,000 $398,000 December 31, 2017 2016, The Company is subject to U.S. federal, California, Colorado, Georgia, Michigan, and New Jersey income taxes. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. The Company was incorporated in 2002 US Tax Reform - Impact of the Tax Cuts and Jobs Act On December 22, 2017, 1 35% 21%, one The key impact of the Tax Act on our financial statement s was the re-measurement of the deferred tax balances to the new corporate tax rate. While we have not No. 118 118” In order to calculate the effects of the new corporate tax rate on our deferred tax balances, ASC 740 740 21 January 1, 2018. $8.2 $8.2 December 31, 2017. The Company has not The provisional amount related to the deferred tax balances are based on information available at this time and may ii) any impact resulting from our December 31, 2017 not one 118. |
Note 17 - Contingencies
Note 17 - Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Contingencies Disclosure [Text Block] | ( 17 ) Contingencies The Company may is not |
Note 18 - Grant Funding
Note 18 - Grant Funding | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Grant Funding [Text Block] | ( 18 ) Grant Funding In June 2016, 1998 ’s research universities and federal labs into the marketplace. TEDCO administers the Maryland Stem Cell Research Fund to promote State funded stem cell research and cures through financial assistance to public and private entities operating within the State. Under the agreement, TEDCO has agreed to provide the Company an amount not $750,000 three As of December 31, 2017, $721,000 $58,000 December 31, 2017. $663,000 December 31, 2017. |
Note 19 - Related Party Transac
Note 19 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | ( 19 ) Related Party Transactions In August 2016, 418,977 4 $1.80 $480,000 $466,000 December 31, 2017 2016, $5.3 4 one 5% 5% |
Note 20 - Employee Benefit Plan
Note 20 - Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | ( 20 Employee Benefit Plans The Company ’s U.S. employees are eligible to participate in a retirement and savings plan that qualifies under Section 401 may 75% not not December 31, 2017, 2016 2015, may |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | (a) Basis of Presentation and Consolidation These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all adjustments necessary for the fair presentation of the Company ’s financial position for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All material intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. |
Going Concern and Liquidity [Policy Text Block] | (b) Liquidity - Going Concern The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $72.5 December 31, 2017. st the next several years. The Company expects to incur increasing costs as the pivotal CardiAMP Heart Failure trial is advanced and development of the CardiAMP and CardiALLO Cell Therapy Systems continue. Therefore absent additional funding, management believes cash and cash equivalents of $12.7 December 31, 2017 not fourth 2018. one not The Company ’s ability to continue as a going concern and to continue further development of its therapeutic candidates through and beyond the fourth 2018, not not may may |
Use of Estimates, Policy [Policy Text Block] | (c) Use of Estimates The preparation of the financial statements in accordance with U.S. GAAP requires Company management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include the useful lives of property and equipment; allowances for doubtful accounts and sales returns; inventory valuation; fair value of the convertible preferred stock warrant liability; fair value of the maturity date preferred stock warrant liability; fair value of the convertible shareholder notes derivative liabilit y; and share-based compensation. |
Cash and Cash Equivalents, Policy [Policy Text Block] | (d) Cash Equivalents The Company classifies all highly liquid investments with original maturities of three months or less at the date of purchase as cash equivalents. The Company maintains its cash and cash equivalents with reputable financial institutions. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | (e) Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company maintains its cash at financial institutions, which at times, exceed federally insured limits. At December 31, 2017, one not not |
Trade and Other Accounts Receivable, Policy [Policy Text Block] | (f) Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not not ’s historical write-off experience, customer creditworthiness, facts and circumstances specific to outstanding balances and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts was $6,000 $2,000 December 31, 2017 2016, |
Inventory, Policy [Policy Text Block] | (g) Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the average-cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company analyzes its inventory levels quarterly and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of and the related costs are recognized in cost of goods sold. |
Deferred Charges, Policy [Policy Text Block] | (h) Deferred Financing Costs Deferred financing costs represent direct costs associated with future issuances of our corporate securities. Direct costs include, but are not not , which was delayed and subsequently withdrawn. The deferred offering costs for that offering in the amount of $1,634,000 2015. |
Property, Plant and Equipment, Policy [Policy Text Block] | (i) Property and Equipment, Net Property and equipment, net are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, as described in the table below. Maintenance and repairs are expensed as incurred. When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the accompanying consolidated statements of operations. Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 years or lease term, if shorter |
Property, Plant and Equipment, Impairment [Policy Text Block] | (j) Long-Lived Assets The Company evaluates long-lived assets such as property and equipment whenever events or changes in circumstances indicate the carrying amount of an asset may not not ’s carrying amount, the asset is written down to its fair value. There have been no |
Clinical Trial Accruals, Policy [Policy Text Block] | (k) Clinical Trial Accruals As part of the process of preparing its consolidated financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiation and may not ’s objective is to reflect the clinical trial expenses in its consolidated financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company makes estimates of its accrued expenses as of each balance sheet date in its consolidated financial statements based on the facts and circumstances known at that time. Although, the Company does not may may |
Derivatives, Policy [Policy Text Block] | (l) Derivatives Fair value accounting requires bifurcation of embedded derivative instruments such as conversion features in equity instruments and warrants granted, and measurement of their fair value. In determining the appropriate fair value of the compound embedded derivative requiring bifurcation from the convertible notes issued in 2015, three |
Lessee, Leases [Policy Text Block] | (m) Deferred Rent The Company ’s lease for its facility provides for fixed increases in minimum annual rental payments. The total amount of rental payments due over the lease term is charged to rent expense ratably over the life of the lease. Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight-line basis. |
Revenue Recognition, Policy [Policy Text Block] | (n) Revenue Recognition The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred, the price to the buyer is fixed or determinable, and collection from the customer is reasonably assured. Net product revenue – The Company currently has a portfolio of enabling and delivery products. The Company recognizes revenue from product sales when title and risk of loss have passed to the customer, which typically occurs upon delivery. Product sale transactions are evidenced by customer purchase orders, customer contracts, invoices and/or related shipping documents. Revenue is recognized net of provisions made for discounts, expected sales returns and allowances. Estimated returns and allowances are based on historical experience and other relevant factors. The Company accepts returns for unused, unopened and resellable product in its original packaging, subject to a restocking fee. The sales return reserve was approximately $ 1,000 December 31, 2017 2016. Amounts received from customers in advance of revenue recognition are recorded as deferred revenue on the consolidated balance sheets. Collaboration agreement revenue two ● The delivered items have value to the customer on a stand-alone basis ● If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company ’s control Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the customer could use the delivered item for its intended purpose without receipt of the remaining deliverables. If an arrangement includes multiple deliverables that are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting based on their relative selling prices and recognizes the associated revenue when the appropriate recognition criteria are met for those deliverables. The amount of allocable arrangement consideration is limited to the amounts that are fixed and determinable. |
Shipping and Handling Cost, Policy [Policy Text Block] | (o) Shipping Costs Costs incurred for the shipping of products to customers totaled approximately $5,000, $7,000 $11,000 December 31, 2017, 2016 2015, |
Standard Product Warranty, Policy [Policy Text Block] | (p) Product Warranties The Company provides a standard warranty of serviceability on all its products for the duration of the product ’s shelf life, which is two not December 31, 2017 2016. |
Research and Development Expense, Policy [Policy Text Block] | (q) Research and Development The Company ’s research and development costs are expensed as incurred. Research and development expense includes the costs of basic research activities as well as other research, engineering, and technical effort required to develop new products or services or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses and support costs for collaborative partnering programs wherein the Company provides biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. The Company’s research and development costs consist primarily of: ● Salaries, benefits and other personnel-related expenses, including share-based compensation ● Fees paid for services provided by clinical research organizations, research institutions, consultants and other outside service providers ● Costs to acquire and manufacture materials used in research and development activities and clinical trials ● Laboratory consumables and supplies ● Facility-related expenses allocated to research and development activities ● Fees to collaborators to license technology ● Depreciation expense for equipment used for research and development and clinical purposes. |
Compensation Related Costs, Policy [Policy Text Block] | (r) Share-Based Compensation The Company measures and recognizes share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. The Company uses the Black-Scholes option pricing model to calculate fair value. Share-based compensation expense recognized in the consolidated statements of operations is based on the period the services are performed. The Company accounts for forfeitures as they occur. For options granted to nonemployees, the Company revalues the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the consolidated statements of operations over the period the related services are rendered. The Black-Scholes option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our share-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate The risk free interest rate assumption is based on the zero Expected Volatility The Company has limited historical data of its own to utilize in determining expected volatility. As such we based our volatility assumption on a combined weighted average of our own historical data and that of a selected peer group. The peer group was developed based on companies in the biotechnology and medical device industries whose shares are publicly-traded. Expected Term The expected term represents the period of time that options are expected to be outstanding. As the Company does not Common Stock Valuation Prior to the completion of the Merger, due to the absence of a public market for the BioCardia Lifesciences common stock, it was necessary to estimate the fair value of the common stock underlying the share-based awards when performing fair value calculations using the BSM option pricing model. The fair value of the common stock underlying the share-based awards was assessed on each grant date by the board of directors of BioCardia Lifesciences. All options to purchase shares of the Company’s common stock have been granted with an exercise price per share no |
Income Tax, Policy [Policy Text Block] | (s) Income Taxes The Company accounts for income taxes based on the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets, liabilities, operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not not In evaluating the ability to recover its deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, forecasts of future taxable income, and ongoing tax planning. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, it would make an adjustment to the valuation allowance, which would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not The Company recognizes and measures benefits for uncertain tax positions using a two first not not second 50% ’s policy is to recognize interest and penalties related to unrecognized tax benefits as a component of income tax expense in the consolidated statements of operations and accrued interest and penalties within accrued liabilities in the consolidated balance sheets. No |
Fair Value of Financial Instruments, Policy [Policy Text Block] | (t) Fair Value of Financial Instruments The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the consolidated financial statements. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Where observable prices or inputs are not The Company ’s financial assets and liabilities consist principally of cash and cash equivalents, accounts receivable, accounts payable, warrants for convertible preferred stock, convertible notes and the convertible shareholder notes derivative liability. The fair value of the Company’s cash equivalents is determined based on quoted prices in active markets for identical assets. The recorded values of the Company’s accounts receivable and accounts payable approximate their current fair values due to the relatively short-term nature of these accounts. The fair value of the Company’s convertible preferred stock warrants is measured using the Black-Scholes option pricing model. Convertible notes are recorded at amortized cost. The fair value of the Company’s convertible shareholder notes derivative liability is measured utilizing a Monte Carlo simulation model. Based on borrowing rates currently available for loans with similar terms, the carrying value of convertible notes approximates fair value. |
Earnings Per Share, Policy [Policy Text Block] | (u) Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of convertible preferred stock, notes convertible into preferred stock, warrants to purchase convertible preferred stock and options outstanding under our stock option plans. For all periods presented, there is no |
New Accounting Pronouncements, Policy [Policy Text Block] | (v) Recently Adopted Accounting Pronouncements In March 2016, No. 2016 09, 718 2016 09 2016 09 January 1, 2017. The impact of adopting ASU 2016 09 ● We classified the excess income tax benefits from stock-based compensation arrangement as a discrete item within income tax expense, rather than recognizing such excess income tax benefits in additional paid-in capital. The adoption of this guidance had no . ● We elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this guidance on a modified retrospective basis was insignificant . ● We applied the change in classification of cash flows resulting from excess tax benefits and cash paid by us when directly withholding shares for tax-withholding purposes on a retrospective basis. The adoption of these provisions did not There were no (w) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 . In August 2015, No. 2015 14 December 15, 2017. not ’s customer contracts and the potential impacts the standard may January 1, 2018 not In January 2016, No. 2016 01 2016 01 2016 01 ’s fiscal year beginning January 1, 2018 not no may 2016 01 January 1, 2018 not In February 2016, No. 2016 02 842 840 2016 02 December 15, 2018; not 2016 02 In May 2017, No. 2017 09 – Stock Compensation (Topic 718 2017 09 718. 2016 01 January 1, 2018 not Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not not ’s financial statement presentation or disclosures. |
Note 2 - Significant Accounti28
Note 2 - Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Property, Plant and Equipment, Useful Life [Table Text Block] | Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 years or lease term, if shorter |
Note 4 - Fair Value Measureme29
Note 4 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | As of December 31, 201 7 Level 1 Level 2 Level 3 Tota l Assets : Cash and cash equivalent s $ 12,689 $ — $ — $ 12,689 As of December 31, 201 6 Level 1 Level 2 Level 3 Tota l Assets : Cash and cash equivalent s $ 21,352 $ — $ — $ 21,352 |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | December 31, 201 7 201 6 Raw material s $ 70 $ 59 Work in proces s 92 — Finished good s 29 76 Tota l $ 191 $ 135 |
Note 6 - Property and Equipme31
Note 6 - Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 201 7 201 6 Computer equipment and softwar e $ 106 143 Laboratory and manufacturing equipmen t 447 366 Furniture and fixture s 48 48 Leasehold improvement s 326 325 Property and equipment, gros s 927 882 Less accumulated depreciatio n (758 ) (771 ) Property and equipment, ne t $ 169 111 |
Note 7 - Commitments (Tables)
Note 7 - Commitments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Lessee, Operating Lease, Disclosure [Table Text Block] | Years ending December 31 : 201 8 $ 594 201 9 612 202 0 630 202 1 649 Tota l $ 2,485 |
Note 9 - Accrued Expenses and33
Note 9 - Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block] | December 31, 201 7 201 6 Accrued expense s $ 539 $ 478 Grant liabilit y 663 304 Customer deposit s 61 66 Tota l $ 1,263 $ 848 |
Note 13 - Share-based Compens34
Note 13 - Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Share-based Compensation, Expense [Table Text Block] | Years ended December 31 , 201 7 201 6 201 5 Cost of goods sol d $ 140 $ 14 $ 4 Research and developmen t 678 127 29 Selling, general and administrativ e 1,889 801 250 Share-based compensation expens e $ 2,707 $ 942 $ 283 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Options outstanding Weighted Weighted Aggregate average average intrinsic Number of exercise remaining contractual value shares price term (years) (in thousands) Balance, December 31, 2016 3,491,937 $ 1.78 8.7 $ 39,046 Stock options granted 842,653 7.66 Stock options exercised ( ) 1.87 Stock options cancelled ( ) 0.48 Balance, December 31, 2017 4,213,100 $ 2.96 8.1 $ 1,890 Exercisable, December 31, 2017 1,556,234 $ 2.28 6.9 $ 844 Unexercisable, December 31, 2017 2,656,866 $ 3.36 8.8 $ 1,046 |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Weighte d averag e grant dat e Number o f fair valu e share s per shar e Balance, December 31, 201 6 — RSUs grante d 97,996 $ 8.71 RSUs veste d — RSUs forfeite d — Balance, December 31, 201 7 97,996 $ 8.71 |
Non-employee Stock Options [Member] | |
Notes Tables | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Years ended December 31 , 201 7 201 6 201 5 Risk-free interest rate 2.25 - 2.40% 1.60 - 2.42% 1.26 - 2.30% Volatility 81 - 87% 89 - 91% 71 - 95% Dividend yield None None None Expected term (in years) 8.6 - 9.8 9.6 - 9.9 8.5 - 9.7 |
Employee Stock Option [Member] | |
Notes Tables | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Years ended December 31 , 201 7 201 6 Risk-free interest rat e 1.76 - 2.25% 1.28 - 1.58% Volatilit y 81 - 89% 88% Dividend yiel d None None Expected term (in years ) 5.00 - 6.25 6.25 |
Note 15 - Net Loss Per Share (T
Note 15 - Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Years ended December 31 , 201 7 201 6 201 5 Numerator : Net los s $ (12,308 ) $ (10,310 ) $ (6,697 ) Denominator : Weighted average shares used to compute net loss per share, basic and dilute d 38,160,543 8,368,284 1,560,293 Net loss per share, basic and diluted $ (0.32 ) $ (1.23 ) $ (4.29 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31 , 201 7 201 6 201 5 Convertible preferred stoc k - - 9,208,376 Notes convertible into share s - - 8,731,657 Convertible preferred stock warrant s - - 194,383 Stock options to purchase common stoc k 4,213,100 3,491,937 1,149,040 Unvested restricted stock unit s 97,996 - - Tota l 4,311,096 3,491,937 19,283,456 |
Note 16 - Income Taxes (Tables)
Note 16 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Years ended December 31 , 201 7 201 6 201 5 Tax at federal statutory rat e $ (4,185 ) $ (3,505 ) $ (2,277 ) State, net of federal benefi t (1,238 ) (315 ) (335 ) Research and development credi t (135 ) (89 ) (51 ) Stock-based compensatio n 344 136 89 Nondeductible interes t — 590 471 Warrant and derivative revaluatio n — 328 (589 ) Change in Federal tax rat e 8,172 — — Othe r 7 94 5 Change in valuation allowanc e (2,965 ) 2,761 2,687 Total provision for income taxe s $ — $ — $ — |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31 , 201 7 201 6 Accrued compensatio n $ 110 $ 154 Inventory adjustment s 449 708 Depreciation and amortization - noncurren t 146 252 Share-based compensatio n 558 273 Net operating loss and tax credit carryforwards - noncurren t 17,368 20,196 Othe r 34 47 Gross deferred tax asse t 18,665 21,630 Valuation allowanc e (18,665 ) (21,630 ) Net deferred tax asse t $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | December 31 , 201 7 201 6 Balance, beginning of yea r $ 608 $ 531 Additions based on tax positions related to the current yea r 117 77 Additions (reductions) for tax positions related to prior year s — — Balance, end of yea r $ 725 $ 608 |
Note 1 - Summary of Business (D
Note 1 - Summary of Business (Details Textual) | Nov. 03, 2017 | Dec. 31, 2017shares | Sep. 25, 2017 | Dec. 31, 2016shares | Oct. 24, 2016shares |
Holders of Issued and Outstanding Shares of Voting Stock Agreed with Reverse Stock Split, Percent | 63.60% | ||||
Common Stock, Shares Authorized | 100,000,000 | 750,000,000 | |||
Preferred Stock, Shares Authorized | 25,000,000 | 50,000,000 | |||
Merger [Member] | |||||
Business Combination, Percentage of Combined Company Owned By Acquirer Immediately After Merger | 54.00% | ||||
Business Combination, Number of Shares of Post-merger Entity for Each Share of Pre-merger Entity | 1.6139834 | ||||
Reverse Stock Split [Member] | |||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 12 |
Note 2 - Significant Accounti38
Note 2 - Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Retained Earnings (Accumulated Deficit) | $ (72,450,000) | $ (60,142,000) | ||
Cash and Cash Equivalents, at Carrying Value | 12,689,000 | 21,352,000 | $ 3,557,000 | $ 3,184,000 |
Allowance for Doubtful Accounts Receivable, Current | 6,000 | 2,000 | ||
Write-off of Deferred Offering Costs | 1,634,000 | |||
Impairment of Long-Lived Assets Held-for-use | 0 | 0 | 0 | |
Sales Returns Reserve | $ 1,000 | 1,000 | ||
Standard Product Warranty, Term | 2 years | |||
Standard Product Warranty Accrual | $ 0 | 0 | ||
Income Tax Examination, Penalties and Interest Accrued | 0 | 0 | 0 | |
Cost of Goods Sold [Member] | ||||
Shipping, Handling and Transportation Costs | $ 5,000 | $ 7,000 | $ 11,000 |
Note 2 - Significant Accounti39
Note 2 - Significant Accounting Policies - Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2017 | |
Computer Equipment and Software [Member] | |
Estimated useful lives (Year) | 3 years |
Laboratory and Manufacturing Equipment [Member] | |
Estimated useful lives (Year) | 3 years |
Furniture and Fixtures [Member] | |
Estimated useful lives (Year) | 3 years |
Leasehold Improvements [Member] | |
Estimated useful lives | 5 years or lease term, if shorter |
Note 3 - Reverse Merger (Detail
Note 3 - Reverse Merger (Details Textual) - USD ($) | Oct. 24, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Cash Acquired in Reverse Merger | $ 19,017,000 | |||
Payments of Transaction Costs for Reverse Merger | $ 96,000 | |||
Assets Acquired from Tiger X [Member] | ||||
Cash Acquired in Reverse Merger | $ 19,000,000 | |||
Payments of Transaction Costs for Reverse Merger | $ 96,000 |
Note 4 - Fair Value Measureme41
Note 4 - Fair Value Measurements - Fair Value of Assets Measured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Assets: | ||
Cash and cash equivalents | $ 12,689 | $ 21,352 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets: | ||
Cash and cash equivalents | 12,689 | 21,352 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets: | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | ||
Assets: | ||
Cash and cash equivalents |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Inventory Write-down | $ 597,000 | ||
Cost of Goods Sold [Member] | |||
Inventory Write-down | $ 33,000 | $ 52,000 | $ 261,000 |
Note 5 - Inventories - Summary
Note 5 - Inventories - Summary of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Raw materials | $ 70 | $ 59 |
Work in process | 92 | |
Finished goods | 29 | 76 |
Total | $ 191 | $ 135 |
Note 6 - Property and Equipme44
Note 6 - Property and Equipment, Net (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Depreciation | $ 78,000 | $ 39,000 | $ 47,000 |
Note 6 - Property and Equipme45
Note 6 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property and equipment, gross | $ 927 | $ 882 |
Less accumulated depreciation | (758) | (771) |
Property and equipment, net | 169 | 111 |
Computer Equipment and Software [Member] | ||
Property and equipment, gross | 106 | 143 |
Laboratory and Manufacturing Equipment [Member] | ||
Property and equipment, gross | 447 | 366 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 48 | 48 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | $ 326 | $ 325 |
Note 7 - Commitments (Details T
Note 7 - Commitments (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Nov. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Lessee, Operating Lease, Term of Contract | 5 years | |||
Operating Leases, Rent Expense, Net | $ 601,000 | $ 321,000 | $ 266,000 |
Note 7 - Commitments - Future M
Note 7 - Commitments - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2017USD ($) |
2,018 | $ 594 |
2,019 | 612 |
2,020 | 630 |
2,021 | 649 |
Total | $ 2,485 |
Note 9 - Accrued Liabilities -
Note 9 - Accrued Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued expenses | $ 539 | $ 478 |
Grant liability | 663 | 304 |
Customer deposits | 61 | 66 |
Total | $ 1,263 | $ 848 |
Note 10 - Convertible Preferr49
Note 10 - Convertible Preferred Stock Warrant Liability (Details Textual) - USD ($) | Oct. 24, 2016 | Dec. 31, 2016 |
Stock Issued During Period, Value, Exchange of Convertible Preferred Stock Warrants to Common Stock | $ 25,000 | $ 25,000 |
Warrant to Purchase Series D Convertible Preferred Stock [Member] | ||
Exchange of Convertible Preferred Stock Warrants for Common Stock, Percentage | 20.00% | |
Stock Issued During Period, Shares, Exchange of Convertible Preferred Stock Warrants to Common Stock | 6,788 | |
Warrant to Purchase Series F Convertible Preferred Stock [Member] | ||
Exchange of Convertible Preferred Stock Warrants for Common Stock, Percentage | 10.00% | |
Stock Issued During Period, Shares, Exchange of Convertible Preferred Stock Warrants to Common Stock | 4,019 |
Note 11 - Convertible Notes (De
Note 11 - Convertible Notes (Details Textual) - USD ($) $ in Thousands | Oct. 24, 2016 | May 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Oct. 23, 2016 |
Interest Expense | $ 0 | $ 1,736 | $ 1,386 | |||
The 2015 Notes [Member] | Convertible Debt [Member] | ||||||
Debt Instrument, Face Amount | $ 7,200 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | |||||
Debt Instrument, Term | 1 year 180 days | |||||
Debt Conversion, Converted Instrument, Shares Issued | 5,620,332 | |||||
The October 2016 Convertible Notes [Member] | Convertible Debt [Member] | ||||||
Debt Instrument, Face Amount | $ 4,400 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | |||||
The October 2016 Convertible Notes [Member] | Convertible Debt [Member] | Merger [Member] | Common Stock [Member] | ||||||
Debt Conversion, Converted Instrument, Shares Issued | 2,470,771 |
Note 12 - Convertible Preferr51
Note 12 - Convertible Preferred Stock (Details Textual) | Oct. 24, 2016shares |
Conversion from Convertible Preferred Stock to Common Stock [Member] | Merger [Member] | |
Conversion of Stock, Shares Issued | 9,208,376 |
Note 13 - Share-based Compens52
Note 13 - Share-based Compensation (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 400,000 | $ 144,000 | $ 137,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 5.80 | $ 1.33 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 842,653 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 4,900,000 | ||
Share-based Compensation | $ 2,707,000 | $ 942,000 | $ 283,000 |
Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 796,399 | 2,190,629 | 0 |
Consultants [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 46,254 | 490,849 | 0 |
Non-employees [Member] | |||
Share-based Compensation | $ 768,000 | $ 545,000 | $ 10,000 |
Employee Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 292 days | ||
Restricted Stock Units (RSUs) [Member] | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 292 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 97,996 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 541,000 | ||
Restricted Stock Units (RSUs) [Member] | Non-employee Directors and Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 97,996 |
Note 13 - Share-based Compens53
Note 13 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based compensation expense | $ 2,707 | $ 942 | $ 283 |
Cost of Goods Sold [Member] | |||
Share-based compensation expense | 140 | 14 | 4 |
Research and Development Expense [Member] | |||
Share-based compensation expense | 678 | 127 | 29 |
Selling, General and Administrative Expenses [Member] | |||
Share-based compensation expense | $ 1,889 | $ 801 | $ 250 |
Note 13 - Share-based Compens54
Note 13 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Stock options outstanding, beginning of period (in shares) | 3,491,937 | |
Balance, weighted average exercise price, beginning of period (in dollars per share) | $ 1.78 | |
Stock options outstanding, weighted average remaining contractual term (Year) | 8 years 36 days | 8 years 255 days |
Stock options outstanding, aggregate intrinsic value | $ 1,890 | $ 39,046 |
Stock options granted (in shares) | 842,653 | |
Stock options granted, weighted average exercise price (in dollars per share) | $ 7.66 | |
Stock options exercised (in shares) | (87,542) | |
Stock options exercised, weighted average exercise price (in dollars per share) | $ 1.87 | |
Stock options cancelled (in shares) | (33,948) | |
Stock options cancelled, weighted average exercise price (in dollars per share) | $ 0.48 | |
Stock options outstanding, end of period (in shares) | 4,213,100 | 3,491,937 |
Balance, weighted average exercise price, end of period (in dollars per share) | $ 2.96 | $ 1.78 |
Exercisable, options outstanding (in shares) | 1,556,234 | |
Exercisable, weighted average exercise price (in dollars per share) | $ 2.28 | |
Stock options exercisable, weighted average remaining contractual term (Year) | 6 years 328 days | |
Stock options exercisable, aggregate intrinsic value | $ 844 | |
Unexercisable, options outstanding (in shares) | 2,656,866 | |
Unexercisable, weighted average exercise price (in dollars per share) | $ 3.36 | |
Stock options unexercisable, weighted average remaining contractual term (Year) | 8 years 292 days | |
Stock options unexercisable, aggregate intrinsic value | $ 1,046 |
Note 13 - Share-based Compens55
Note 13 - Share-based Compensation - Valuation Assumptions for Employee Stock Options (Details) - Employee Stock Option [Member] | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Volatility | 88.00% | |
Dividend yield | 0.00% | 0.00% |
Expected term (in years) (Year) | 6 years 91 days | |
Minimum [Member] | ||
Risk-free interest rate | 1.76% | 1.28% |
Volatility | 81.00% | |
Expected term (in years) (Year) | 5 years | |
Maximum [Member] | ||
Risk-free interest rate | 2.25% | 1.58% |
Volatility | 89.00% | |
Expected term (in years) (Year) | 6 years 91 days |
Note 13 - Share-based Compens56
Note 13 - Share-based Compensation - Summary of Non-vested RSUs (Details) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Balance, Shares (in shares) | shares | |
Balance, Weighted average grant date fair value per share (in dollars per share) | $ / shares | |
RSUs granted, Shares (in shares) | shares | 97,996 |
RSUs granted, Weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 8.71 |
RSUs vested, Shares (in shares) | shares | |
RSUs vested, Weighted average grant date fair value per share (in dollars per share) | $ / shares | |
RSUs forfeited, Shares (in shares) | shares | |
RSUs forfeited, Weighted average grant date fair value per share (in dollars per share) | $ / shares | |
Balance, Shares (in shares) | shares | 97,996 |
Balance, Weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 8.71 |
Note 13 - Share-based Compens57
Note 13 - Share-based Compensation - Nonemployee Stock Option Valuation Assumptions (Details) - Non-employee Stock Options [Member] | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Risk-free interest rate | 2.25% | 1.60% | 1.26% |
Volatility | 81.00% | 89.00% | 71.00% |
Expected term (in years) (Year) | 8 years 219 days | 9 years 219 days | 8 years 182 days |
Maximum [Member] | |||
Risk-free interest rate | 2.40% | 2.42% | 2.30% |
Volatility | 87.00% | 91.00% | 95.00% |
Expected term (in years) (Year) | 9 years 292 days | 9 years 328 days | 9 years 255 days |
Note 14 - Concentrations (Detai
Note 14 - Concentrations (Details Textual) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Sales Revenue, Net [Member] | |||
Number of Major Customers | 0 | 0 | 0 |
Accounts Receivable [Member] | |||
Number of Major Customers | 1 | 1 | |
Concentration Risk, Percentage | 20.00% | 29.00% |
Note 15 - Net Loss Per Share -
Note 15 - Net Loss Per Share - Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net loss | $ (12,308) | $ (10,310) | $ (6,697) |
Weighted-average shares used in computing net loss per share, basic and diluted (in shares) | 38,160,543 | 8,368,284 | 1,560,293 |
Net loss per share, basic and diluted (in dollars per share) | $ (0.32) | $ (1.23) | $ (4.29) |
Note 15 - Net Loss Per Share 60
Note 15 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive securities (in shares) | 4,311,096 | 3,491,937 | 19,283,456 |
Convertible Preferred Stock [Member] | |||
Antidilutive securities (in shares) | 9,208,376 | ||
Convertible Debt Securities [Member] | |||
Antidilutive securities (in shares) | 8,731,657 | ||
Warrant [Member] | |||
Antidilutive securities (in shares) | 194,383 | ||
Employee Stock Option [Member] | |||
Antidilutive securities (in shares) | 4,213,100 | 3,491,937 | 1,149,040 |
Restricted Stock Units (RSUs) [Member] | |||
Antidilutive securities (in shares) | 97,996 |
Note 16 - Income Taxes (Details
Note 16 - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 | $ 0 | |
Deferred Tax Liabilities, Net | 0 | 0 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (3,000,000) | 2,800,000 | ||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | $ 511,000 | $ 398,000 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | |||
Changes in Deferred Tax Assets Before Valuation Allowance, Due to Changes in Enacted Tax Rate | $ (8,200,000) | |||
Deferred Tax Assets Remeasurement [Member] | ||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (8,200,000) | |||
Scenario, Forecast [Member] | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | |||
Domestic Tax Authority [Member] | Internal Revenue Service (IRS) [Member] | ||||
Operating Loss Carryforwards | 57,600,000 | |||
Domestic Tax Authority [Member] | Internal Revenue Service (IRS) [Member] | Research Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward, Amount | 1,600,000 | |||
State and Local Jurisdiction [Member] | ||||
Operating Loss Carryforwards | 47,700,000 | |||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||||
Tax Credit Carryforward, Amount | $ 1,300,000 |
Note 16 - Income Taxes - Effect
Note 16 - Income Taxes - Effective Income Tax Reconciliation (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Tax at federal statutory rate | $ (4,185,000) | $ (3,505,000) | $ (2,277,000) |
State, net of federal benefit | (1,238,000) | (315,000) | (335,000) |
Research and development credit | (135,000) | (89,000) | (51,000) |
Stock-based compensation | 344,000 | 136,000 | 89,000 |
Nondeductible interest | 590,000 | 471,000 | |
Warrant and derivative revaluation | 328,000 | (589,000) | |
Change in Federal tax rate | 8,172,000 | ||
Other | 7,000 | 94,000 | 5,000 |
Change in valuation allowance | (2,965,000) | 2,761,000 | 2,687,000 |
Total provision for income taxes | $ 0 | $ 0 | $ 0 |
Note 16 - Income Taxes - Compon
Note 16 - Income Taxes - Components of the Net Deferred Income Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued compensation | $ 110 | $ 154 |
Inventory adjustments | 449 | 708 |
Depreciation and amortization - noncurrent | 146 | 252 |
Share-based compensation | 558 | 273 |
Net operating loss and tax credit carryforwards - noncurrent | 17,368 | 20,196 |
Other | 34 | 47 |
Gross deferred tax asset | 18,665 | 21,630 |
Valuation allowance | (18,665) | (21,630) |
Net deferred tax asset |
Note 16 - Income Taxes - Aggreg
Note 16 - Income Taxes - Aggregate Changes in the Balance of Gross Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Balance, beginning of year | $ 608 | $ 531 |
Additions based on tax positions related to the current year | 117 | 77 |
Additions (reductions) for tax positions related to prior years | ||
Balance, end of year | $ 725 | $ 608 |
Note 18 - Grant Funding (Detail
Note 18 - Grant Funding (Details Textual) - Grant Agreement [Member] - TEDCO [Member] - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2017 | |
Grant Funding Available | $ 750,000 | |
Grant Funding, Term of Grant | 3 years | |
Proceeds from Grant Funding | $ 721,000 | |
Research and Development Expense Reduction from Qualified Grant Funding | 58,000 | |
Deferred Revenue from Grants, Current | $ 663,000 |
Note 19 - Related Party Trans66
Note 19 - Related Party Transactions (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 842,653 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 2.96 | $ 1.78 | ||
Share-based Compensation | $ 2,707,000 | $ 942,000 | $ 283,000 | |
OPKO [Member] | ||||
Related Party, Ownership Percentage | 5.00% | |||
OPKO [Member] | Consulting Services [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 418,977 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price | $ 1.80 | |||
Share-based Compensation | 480,000 | $ 466,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested Grant Date Fair Value | $ 5,300,000 | |||
Consulting Agreement, Term | 4 years | |||
Consulting Agreement, Term, Length of Automatic Renewal Periods | 1 year | |||
Chairman and Chief Executive Officer of OPKO [Member] | ||||
Related Party, Ownership Percentage | 5.00% |
Note 20 - Employee Benefit Pl67
Note 20 - Employee Benefit Plans (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 75.00% | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0 | $ 0 | $ 0 |