Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 14, 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) | 457,818,571 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 15,109 | $ 21,352 |
Accounts receivable, net of allowance for doubtful accounts of $1 and $2 at June 30, 2017 and December 31, 2016, respectively | 142 | 74 |
Inventory | 193 | 135 |
Short-term investments | 1,796 | |
Prepaid expenses | 282 | 356 |
Total current assets | 17,522 | 21,917 |
Property and equipment, net | 180 | 111 |
Other assets | 54 | 54 |
Total assets | 17,756 | 22,082 |
Current liabilities: | ||
Accounts payable | 590 | 525 |
Accrued expenses and other current liabilities | 864 | 848 |
Deferred revenue | 153 | 71 |
Total current liabilities | 1,607 | 1,444 |
Deferred rent | 68 | 56 |
Total liabilities | 1,675 | 1,500 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 50,000,000 shares authorized, no shares issued and outstanding at June 30, 2017 and December 31, 2016 | ||
Common stock, $0.001 par value, 750,000,000 shares authorized at June 30, 2017 and December 31, 2016, 457,682,784 shares and 457,575,631 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 458 | 458 |
Additional paid-in capital | 81,586 | 80,266 |
Accumulated deficit | (65,963) | (60,142) |
Total stockholders’ equity | 16,081 | 20,582 |
Total liabilities and stockholders’ equity | $ 17,756 | $ 22,082 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Allowance for doubtful accounts | $ 1 | $ 2 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 50,000,000 | 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) | 750,000,000 | 750,000,000 |
Common stock, shares issued (in shares) | 457,682,784 | 457,575,631 |
Common stock, shares outstanding (in shares) | 457,682,784 | 457,575,631 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenue: | ||||
Net product revenue | $ 101,000 | $ 138,000 | $ 210,000 | $ 306,000 |
Collaboration agreement revenue | 11,000 | 6,000 | 39,000 | 16,000 |
Total revenue | 112,000 | 144,000 | 249,000 | 322,000 |
Costs and expenses: | ||||
Cost of goods sold | 203,000 | 156,000 | 378,000 | 382,000 |
Research and development | 1,295,000 | 497,000 | 2,328,000 | 938,000 |
Selling, general and administrative | 1,582,000 | 869,000 | 3,386,000 | 1,456,000 |
Total costs and expenses | 3,080,000 | 1,522,000 | 6,092,000 | 2,776,000 |
Operating loss | (2,968,000) | (1,378,000) | (5,843,000) | (2,454,000) |
Other income (expense): | ||||
Interest income | 23,000 | 23,000 | ||
Interest expense | 0 | (557,000) | 0 | (1,107,000) |
Change in fair value of convertible preferred stock warrant liability | 167,000 | 220,000 | ||
Change in fair value of maturity date preferred stock warrant liability | 8,000 | 7,000 | ||
Change in fair value of convertible shareholder notes derivative liability | (217,000) | (139,000) | ||
Other income (expense), net | (1,000) | (1,000) | (1,000) | |
Total other income (expense), net | 23,000 | (600,000) | 22,000 | (1,020,000) |
Net loss | $ (2,945,000) | $ (1,978,000) | $ (5,821,000) | $ (3,474,000) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.01) | $ (0.11) | $ (0.01) | $ (0.19) |
Weighted-average shares used in computing net loss per share, basic and diluted (in shares) | 457,682,784 | 18,723,511 | 457,668,755 | 18,723,511 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities: | ||
Net loss | $ (5,821) | $ (3,474) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 36 | 21 |
Change in fair value of convertible preferred stock warrant liability | (220) | |
Change in fair value of maturity date preferred stock warrant liability | (7) | |
Change in fair value of convertible shareholder notes derivative liability | 139 | |
Stock based compensation | 1,298 | 58 |
Non-cash interest expense on convertible shareholder notes | 1,107 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (68) | 22 |
Inventory | (58) | 18 |
Prepaid expenses | 74 | 98 |
Accounts payable | 60 | 185 |
Accrued expenses and other current liabilities, excluding accrued interest on convertible note | 16 | 161 |
Deferred revenue | 82 | 37 |
Deferred rent | 12 | (15) |
Net cash used in operating activities | (4,369) | (1,870) |
Investing activities: | ||
Purchase of property and equipment | (100) | |
Purchase of short-term investments | (1,796) | |
Net cash used in investing activities | (1,896) | |
Financing activities: | ||
Proceeds from the exercise of stock options | 22 | |
Net cash provided by financing activities | 22 | |
Net decrease in cash and cash equivalents | (6,243) | (1,870) |
Cash and cash equivalents at beginning of period | 21,352 | 3,557 |
Cash and cash equivalents at end of period | 15,109 | 1,687 |
Supplemental disclosures for noncash investing activity: | ||
Accounts payable recognized for the purchase of equipment | $ 5 |
Note 1 - Summary of Business an
Note 1 - Summary of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | ( 1 S ummary of Business and Basis of Presentation (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 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 19.3678009 |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | ( 2 Significant Accounting Policies (a) Basis of Preparation The accompanying condensed consolidated balance sheets, statements of operations, comprehensive loss and cash flows as of June 30, 2017 three six June 30, 2017 2016 June 30, 2017, three six June 30, 2017 2016, six June 30, 2017 2016. three six June 30, 2017 not December 31, 2017 These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10 December 31, 2016, March 30, 2017. (b) Liquidity The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $66 June 30, 2017. Based on management’s current plans, management believes cash and cash equivalents of $15.1 $1.8 June 30, 2017 third 2018. second Q3 2018, not may may no (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 liability; and share-based compensation. (d) Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated during the consolidation process. (e) Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 2016 10 no (f ) Investments Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 365 Premiums and discounts on debt securities are amortized or accreted over the life of the security as an adjustment to yield using the effective-interest method. Such amortization and accretion is reported as interest income (expense) in the statement of operations. Dividend and interest income are recognized when earned. (g ) Recently Adopted Accounting Pronouncement In March 2016, 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 (g) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 In August 2015, 2015 14 December 15, 2017 December 15, 2016, not may In February 2016, 2016 02 842 840 2016 02 December 15, 2018; not 2016 02 In May 2017, 2017 09 718 2017 09 718. 2017 09, December 15, 2017, 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 |
Note 3 - Fair Value Measurement
Note 3 - Fair Value Measurement | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | ( 3 Fair Value Measurement 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 Level 1 Level 2 not Level 3 no The Company’s money market instruments are classified as Level 2 2 The following table sets forth the fair value of our financial assets measured on a recurring basis as of June 30, 2017 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash $ 3,901 $ — $ — $ 3,901 Money market instruments — 8,711 — 8,711 US government securities — 649 — 649 US government agency securities — 1,848 — 1,848 Total cash and cash equivalents $ 3,901 $ 11,208 $ — $ 15,109 Marketable securities: US government securities — 1,796 — 1,796 Total marketable securities $ — $ 1,796 $ — $ 1,796 The following table sets forth the fair value of our financial assets measured on a recurring basis as of December 31, 2016 Level 1 Level 2 Level 3 Total Assets: Cash $ 21,352 $ — $ — $ 21,352 As discussed in Note 8, 2015, No June 30, 2017. In May 2015, $7.2 2015 8, 2015 June 30, 2016. 2015 not October 24, 2016. No June 30, 2017. |
Note 4 - Investments
Note 4 - Investments | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Investment [Text Block] | ( 4 ) Investments The following table summarizes the estimated value of the Company’s cash equivalents and marketable securities and the gross unrealized gains and losses as of June 30, 2017 ( Amortized cost Unrealized gain Unrealized loss Estimated Fair Value US government securities $ 1,796 $ — $ — $ 1,796 Total marketable securities $ 1,796 $ — $ — $ 1,796 As of June 30, 2017, one no 6 months ended June 30, 2017. |
Note 5 - Inventories
Note 5 - Inventories | 6 Months Ended |
Jun. 30, 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): June 30, 2017 December 31, 2016 Raw materials $ 62 59 Work in process 16 — Finished goods 115 76 Total $ 193 135 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 $1,000 $19,000 three June 30, 2017 2016, $10,000 $37,000 six June 30, 2017 2016, |
Note 6 - Property and Equipment
Note 6 - Property and Equipment, Net | 6 Months Ended |
Jun. 30, 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): June 30, 2017 December 31, 2016 Computer equipment and software $ 183 143 Laboratory and manufacturing equipment 431 366 Furniture and fixtures 48 48 Leasehold improvements 325 325 Property and equipment, gross 987 882 Less accumulated depreciation (807 ) (771 ) Property and equipment, net $ 180 111 Depreciation expense totaled approximately $23,000 $11,000 three June 30, 2017 2016, $36,000 $21,000 six June 30, 2017 2016, |
Note 7 - Accrued Expenses and O
Note 7 - Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Accrued Liabilities and Other Current Liabilities Disclosure [Text Block] | ( 7 ) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2017 December 31, 2016 Accrued expenses $ 406 478 Accrued clinical trial costs 126 — Grant liability 269 304 Customer deposits 63 66 Total $ 864 848 |
Note 8 - Convertible Notes
Note 8 - Convertible Notes | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | ( 8 ) Convertible Notes In May 2015, $7.2 2015 2015 8% 18 1933, 80% $5.0 may 80% 8% $0.07 8% In August 2016, 2015 2015 August 31, 2016 80% October 2016. August 31, 2016, 2015 67,443,988 The 2015 2015 not The Company recognized interest expense, including amortization of the debt discount of approximately $0 $557,000 three June 30, 2017 2016, $0 $1.1 six June 30, 2017 2016, |
Note 9 - Share-based Compensati
Note 9 - Share-based Compensation | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | ( 9 ) Share-Based Compensation BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2002 2002, 2002 2002 not 2002 2016, 2016 2016 2016 2016 Stock compensation attributable to manufacturing operations was not three six June 30, 2017 2016 Three Months ended June 30, Six Months ended June 30, 2017 2016 2017 2016 Cost of goods sold $ 33 $ — $ 74 $ 1 Research and development 154 — 326 1 Selling, general and administrative 489 28 898 56 Share-based compensation expense $ 676 $ 28 $ 1,298 $ 58 The following table summarizes the activity of stock options and related information: Options outstanding Weighted average Number of exercise shares price Balance, December 31, 2016 41,903,728 $ 0.15 Stock options granted 6,714,410 0.73 Stock options exercised (107,153 ) 0.20 Stock options cancelled (407,382 ) 0.04 Balance, June 30, 2017 48,103,603 $ 0.23 The weighted average grant-date fair value of options granted during the six June 30, 2017 $0.57 Employee Share-Based Compensation (Stock Options) During the six June 30, 2017, 4,766,627 Risk-free interest rate 1.88 – 2.12% Volatility 85 – 89% Dividend yield None Expected terms (in years) 5.50 – 6.25 Unrecognized share-based compensation for employee options granted through June 30, 2017 $4.4 3.0 Employee Share-Based Compensation (RSUs) During the six June 30, 2017, 1,176,000 The following summarizes the activity of non-vested RSUs: Weighted average grant date Number of fair value shares per share Balance, December 31, 2016 — RSUs granted 1,176,000 $ 0.73 RSUs vested — RSUs forfeited — Balance, June 30, 2017 1,176,000 $ 0.73 Unrecognized share-based compensation for employee RSUs granted through June 30, 2017 $742,000 2.1 Nonemployee Share-Based Compensation During the six June 30, 2017, 1,947,783 $277,000 $1,000 three June 30, 2017 2016, $510,000 $2,000 six June 30, 2017 2016, The Company accounts for share-based compensation arrangements with nonemployees, using the BSM 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 as of June 30, 2017: Risk-free interest rate 2.25 – 2.28% Volatility 87% Dividend yield None Expected terms (in years) 9.1 – 9.5 |
Note 10 - Net Loss Per Share
Note 10 - Net Loss Per Share | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | ( 10 ) Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Since we were in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following 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: June 30, 2017 2016 Stock options to purchase common stock 48,103,603 12,464,656 Restricted stock units 1,176,000 - Total 49,279,603 12,464,656 |
Note 11 - Income Taxes
Note 11 - Income Taxes | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | ( 11 Income Taxes During the six June 30, 2017 2016, no As of June 30, 2017, not not |
Note 12 - Related Party Transac
Note 12 - Related Party Transactions | 6 Months Ended |
Jun. 30, 2017 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | ( 12 Related Party Transactions In August 2016, 5,027,726 4 June 30, 2017, $184,000 $306,000 three six June 30, 2017, 4 one 5% 5% |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | (a) Basis of Preparation The accompanying condensed consolidated balance sheets, statements of operations, comprehensive loss and cash flows as of June 30, 2017 three six June 30, 2017 2016 June 30, 2017, three six June 30, 2017 2016, six June 30, 2017 2016. three six June 30, 2017 not December 31, 2017 These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10 December 31, 2016, March 30, 2017. |
Going Concern and Liquidity [Policy Text Block] | (b) Liquidity The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $66 June 30, 2017. Based on management’s current plans, management believes cash and cash equivalents of $15.1 $1.8 June 30, 2017 third 2018. second Q3 2018, not may may no |
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 liability; and share-based compensation. |
Consolidation, Policy [Policy Text Block] | (d) Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated during the consolidation process. |
Investment, Policy [Policy Text Block] | (f ) Investments Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 365 Premiums and discounts on debt securities are amortized or accreted over the life of the security as an adjustment to yield using the effective-interest method. Such amortization and accretion is reported as interest income (expense) in the statement of operations. Dividend and interest income are recognized when earned. |
New Accounting Pronouncements, Policy [Policy Text Block] | (g ) Recently Adopted Accounting Pronouncement In March 2016, 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 (g) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 In August 2015, 2015 14 December 15, 2017 December 15, 2016, not may In February 2016, 2016 02 842 840 2016 02 December 15, 2018; not 2016 02 In May 2017, 2017 09 718 2017 09 718. 2017 09, December 15, 2017, 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 |
Note 3 - Fair Value Measureme19
Note 3 - Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash $ 3,901 $ — $ — $ 3,901 Money market instruments — 8,711 — 8,711 US government securities — 649 — 649 US government agency securities — 1,848 — 1,848 Total cash and cash equivalents $ 3,901 $ 11,208 $ — $ 15,109 Marketable securities: US government securities — 1,796 — 1,796 Total marketable securities $ — $ 1,796 $ — $ 1,796 Level 1 Level 2 Level 3 Total Assets: Cash $ 21,352 $ — $ — $ 21,352 |
Note 4 - Investments (Tables)
Note 4 - Investments (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Unrealized Gain (Loss) on Investments [Table Text Block] | Amortized cost Unrealized gain Unrealized loss Estimated Fair Value US government securities $ 1,796 $ — $ — $ 1,796 Total marketable securities $ 1,796 $ — $ — $ 1,796 |
Note 5 - Inventories (Tables)
Note 5 - Inventories (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | June 30, 2017 December 31, 2016 Raw materials $ 62 59 Work in process 16 — Finished goods 115 76 Total $ 193 135 |
Note 6 - Property and Equipme22
Note 6 - Property and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | June 30, 2017 December 31, 2016 Computer equipment and software $ 183 143 Laboratory and manufacturing equipment 431 366 Furniture and fixtures 48 48 Leasehold improvements 325 325 Property and equipment, gross 987 882 Less accumulated depreciation (807 ) (771 ) Property and equipment, net $ 180 111 |
Note 7 - Accrued Expenses and23
Note 7 - Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block] | June 30, 2017 December 31, 2016 Accrued expenses $ 406 478 Accrued clinical trial costs 126 — Grant liability 269 304 Customer deposits 63 66 Total $ 864 848 |
Note 9 - Share-based Compensa24
Note 9 - Share-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Weighted average grant date Number of fair value shares per share Balance, December 31, 2016 — RSUs granted 1,176,000 $ 0.73 RSUs vested — RSUs forfeited — Balance, June 30, 2017 1,176,000 $ 0.73 |
Schedule of Share-based Compensation, Expense [Table Text Block] | Three Months ended June 30, Six Months ended June 30, 2017 2016 2017 2016 Cost of goods sold $ 33 $ — $ 74 $ 1 Research and development 154 — 326 1 Selling, general and administrative 489 28 898 56 Share-based compensation expense $ 676 $ 28 $ 1,298 $ 58 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Options outstanding Weighted average Number of exercise shares price Balance, December 31, 2016 41,903,728 $ 0.15 Stock options granted 6,714,410 0.73 Stock options exercised (107,153 ) 0.20 Stock options cancelled (407,382 ) 0.04 Balance, June 30, 2017 48,103,603 $ 0.23 |
Non-employee Stock Options [Member] | |
Notes Tables | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Risk-free interest rate 2.25 – 2.28% Volatility 87% Dividend yield None Expected terms (in years) 9.1 – 9.5 |
Employee Stock Option [Member] | |
Notes Tables | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Risk-free interest rate 1.88 – 2.12% Volatility 85 – 89% Dividend yield None Expected terms (in years) 5.50 – 6.25 |
Note 10 - Net Loss Per Share (T
Note 10 - Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | June 30, 2017 2016 Stock options to purchase common stock 48,103,603 12,464,656 Restricted stock units 1,176,000 - Total 49,279,603 12,464,656 |
Note 1 - Summary of Business 26
Note 1 - Summary of Business and Basis of Presentation (Details Textual) - Merger [Member] | Oct. 24, 2016shares |
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 | 19.3678009 |
Note 2 - Significant Accounti27
Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 | Jun. 30, 2016 | Dec. 31, 2015 |
Retained Earnings (Accumulated Deficit) | $ (65,963) | $ (60,142) | ||
Cash and Cash Equivalents, at Carrying Value | 15,109 | 21,352 | $ 1,687 | $ 3,557 |
Short-term Investments | $ 1,796 |
Note 3 - Fair Value Measureme28
Note 3 - Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | Jun. 30, 2017 | May 31, 2015 |
Warrants and Rights Outstanding | $ 0 | |
Notes Payable | $ 0 | |
The 2015 Notes [Member] | ||
Debt Instrument, Face Amount | $ 7,200 |
Note 3 - Fair Value Measureme29
Note 3 - Fair Value Measurement - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Marketable securities | $ 1,796 | |
Fair Value, Measurements, Recurring [Member] | ||
Cash and cash equivalents | 15,109 | $ 21,352 |
Marketable securities | 1,796 | |
Fair Value, Measurements, Recurring [Member] | U.S. States and Political Subdivisions Debt Securities [Member] | ||
Marketable securities | 1,796 | |
Fair Value, Measurements, Recurring [Member] | Cash [Member] | ||
Cash and cash equivalents | 3,901 | |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash and cash equivalents | 8,711 | |
Fair Value, Measurements, Recurring [Member] | US States and Political Subdivisions Debt Securities [Member] | ||
Cash and cash equivalents | 649 | |
Fair Value, Measurements, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and cash equivalents | 1,848 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash and cash equivalents | 3,901 | 21,352 |
Marketable securities | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | U.S. States and Political Subdivisions Debt Securities [Member] | ||
Marketable securities | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Cash [Member] | ||
Cash and cash equivalents | 3,901 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | US States and Political Subdivisions Debt Securities [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash and cash equivalents | 11,208 | |
Marketable securities | 1,796 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | U.S. States and Political Subdivisions Debt Securities [Member] | ||
Marketable securities | 1,796 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | Cash [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash and cash equivalents | 8,711 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | US States and Political Subdivisions Debt Securities [Member] | ||
Cash and cash equivalents | 649 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and cash equivalents | 1,848 | |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash and cash equivalents | ||
Marketable securities | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | U.S. States and Political Subdivisions Debt Securities [Member] | ||
Marketable securities | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | Cash [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | US States and Political Subdivisions Debt Securities [Member] | ||
Cash and cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | ||
Cash and cash equivalents |
Note 4 - Investments (Details T
Note 4 - Investments (Details Textual) $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Other than Temporary Impairment Losses, Investments | $ 0 |
Note 4 - Investments - Summary
Note 4 - Investments - Summary of Cash Equivalents and Marketable Securities (Details) $ in Thousands | Jun. 30, 2017USD ($) |
Marketable securities, amortized cost | $ 1,796 |
Marketable securities, unrealized gain | |
Marketable securities, unrealized loss | |
Marketable securities | 1,796 |
US States and Political Subdivisions Debt Securities [Member] | |
Marketable securities, amortized cost | 1,796 |
Marketable securities, unrealized gain | |
Marketable securities, unrealized loss | |
Marketable securities | $ 1,796 |
Note 5 - Inventories (Details T
Note 5 - Inventories (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Inventory Write-down | $ 1,000 | $ 19,000 | $ 10,000 | $ 37,000 |
Note 5 - Inventories - Inventor
Note 5 - Inventories - Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Raw materials | $ 62 | $ 59 |
Work in process | 16 | |
Finished goods | 115 | 76 |
Total | $ 193 | $ 135 |
Note 6 - Property and Equipme34
Note 6 - Property and Equipment, Net (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Depreciation | $ 23,000 | $ 11,000 | $ 36,000 | $ 21,000 |
Note 6 - Property and Equipme35
Note 6 - Property and Equipment, Net - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Property and equipment, gross | $ 987 | $ 882 |
Less accumulated depreciation | (807) | (771) |
Property and equipment, net | 180 | 111 |
Computer Equipment and Software [Member] | ||
Property and equipment, gross | 183 | 143 |
Laboratory and Manufacturing Equipment [Member] | ||
Property and equipment, gross | 431 | 366 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 48 | 48 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | $ 325 | $ 325 |
Note 7 - Accrued Expenses and36
Note 7 - Accrued Expenses and Other Current Liabilities - Accrued Liabilities and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Accrued expenses | $ 406 | $ 478 |
Accrued clinical trial costs | 126 | |
Grant liability | 269 | 304 |
Customer deposits | 63 | 66 |
Total | $ 864 | $ 848 |
Note 8 - Convertible Notes (Det
Note 8 - Convertible Notes (Details Textual) - USD ($) | Oct. 24, 2016 | May 31, 2015 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Aug. 31, 2016 |
Interest Expense | $ 0 | $ 557,000 | $ 0 | $ 1,107,000 | |||
The 2015 Notes [Member] | |||||||
Debt Instrument, Face Amount | $ 7,200,000 | ||||||
The 2015 Notes [Member] | Convertible Debt [Member] | |||||||
Debt Instrument, Face Amount | $ 7,200,000 | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | ||||||
Debt Instrument, Term | 1 year 180 days | ||||||
Debt Instrument, Convertible, Automatic Conversion of Principle and Accrued Interest into Shares of Common Stock, Percentage of Price of Shares Purchased in IPO | 80.00% | ||||||
Debt Instrument, Convertible, Optional Conversion Right, Trigger, Private Placement of Preferred Stock, Aggregate Sales Proceeds | $ 5,000,000 | ||||||
Debt Instrument, Convertible, Optional Conversion Right, Conversion Price, Percentage of the Price of the Preferred Shares | 80.00% | ||||||
Debt Instrument, Convertible, Optional Conversion Right, Warrant Coverage, Percent | 8.00% | ||||||
Debt Instrument, Convertible, Conversion Price | $ 0.07 | ||||||
Debt Instrument, Convertible, Optional Conversion Right at Maturity, Warrant Coverage, Percent | 8.00% | ||||||
Debt Instrument, Convertible, Conversion to Common Stock, Conversion Price, Percentage of the Price of the Convertible Notes to Be Issued | 80.00% | ||||||
The 2015 Notes [Member] | Convertible Debt [Member] | Merger [Member] | |||||||
Debt Conversion, Converted Instrument, Shares Issued | 67,443,988 |
Note 9 - Share-based Compensa38
Note 9 - Share-based Compensation (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 4,400,000 | $ 4,400,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0.57 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 6,714,410 | |||
Share-based Compensation | $ 1,298,000 | $ 58,000 | ||
Employee Stock Option [Member] | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 3 years | |||
Restricted Stock Units (RSUs) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 1,176,000 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | 742,000 | $ 742,000 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 36 days | |||
Non-employee Directors and Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 4,766,627 | |||
Non-employee Directors and Employees [Member] | Restricted Stock Units (RSUs) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 1,176,000 | |||
Consultants [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 1,947,783 | |||
Non-employees [Member] | ||||
Share-based Compensation | $ 277,000 | $ 1,000 | $ 510,000 | $ 2,000 |
Note 9 - Share-based Compensa39
Note 9 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Employee share-based compensation expense | $ 676 | $ 28 | $ 1,298 | $ 58 |
Cost of Goods Sold [Member] | ||||
Employee share-based compensation expense | 33 | 74 | 1 | |
Research and Development Expense [Member] | ||||
Employee share-based compensation expense | 154 | 326 | 1 | |
Selling, General and Administrative Expenses [Member] | ||||
Employee share-based compensation expense | $ 489 | $ 28 | $ 898 | $ 56 |
Note 9 - Share-based Compensa40
Note 9 - Share-based Compensation - Stock Option Activity (Details) | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Stock options outstanding, beginning of period (in shares) | shares | 41,903,728 |
Balance, weighted average exercise price, beginning of period (in dollars per share) | $ / shares | $ 0.15 |
Stock options granted (in shares) | shares | 6,714,410 |
Stock options granted (in dollars per share) | $ / shares | $ 0.73 |
Stock options exercised (in shares) | shares | (107,153) |
Stock options exercised, weighted average exercise price (in dollars per share) | $ / shares | $ 0.20 |
Stock options cancelled (in shares) | shares | (407,382) |
Stock options cancelled, weighted average exercise price (in dollars per share) | $ / shares | $ 0.04 |
Stock options outstanding, end of period (in shares) | shares | 48,103,603 |
Balance, weighted average exercise price, end of period (in dollars per share) | $ / shares | $ 0.23 |
Note 9 - Share-based Compensa41
Note 9 - Share-based Compensation - Valuation Assumptions for Employee Stock Options (Details) - Employee Stock Option [Member] | 6 Months Ended |
Jun. 30, 2017 | |
Risk-free interest rate, minimum | 1.88% |
Risk-free interest rate, maximum | 2.12% |
Volatility, minimum | 85.00% |
Volatility, maximum | 89.00% |
Dividend yield | 0.00% |
Minimum [Member] | |
Expected terms (Year) | 5 years 182 days |
Maximum [Member] | |
Expected terms (Year) | 6 years 91 days |
Note 9 - Share-based Compensa42
Note 9 - Share-based Compensation - Summary of Non-vested RSUs (Details) - Restricted Stock Units (RSUs) [Member] | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Balance (in shares) | shares | |
Balance (in dollars per share) | $ / shares | |
RSUs granted (in shares) | shares | 1,176,000 |
RSUs granted (in dollars per share) | $ / shares | $ 0.73 |
RSUs vested (in shares) | shares | |
RSUs vested (in dollars per share) | $ / shares | |
Balance (in dollars per share) | $ / shares | $ 0.73 |
RSUs forfeited (in shares) | shares | |
RSUs forfeited (in dollars per share) | $ / shares | |
Balance (in shares) | shares | 1,176,000 |
Note 9 - Share-based Compensa43
Note 9 - Share-based Compensation - Nonemployee Stock Option Valuation Assumptions (Details) - Non-employee Stock Options [Member] | 6 Months Ended |
Jun. 30, 2017 | |
Risk-free interest rate, minimum | 2.25% |
Risk-free interest rate, maximum | 2.28% |
Volatility | 87.00% |
Dividend yield | 0.00% |
Minimum [Member] | |
Expected terms (Year) | 9 years 36 days |
Maximum [Member] | |
Expected terms (Year) | 9 years 182 days |
Note 10 - Net Loss Per Share -
Note 10 - Net Loss Per Share - Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Antidilutive securities (in shares) | 49,279,603 | 12,464,656 |
Employee Stock Option [Member] | ||
Antidilutive securities (in shares) | 48,103,603 | 12,464,656 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive securities (in shares) | 1,176,000 |
Note 11 - Income Taxes (Details
Note 11 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Deferred Tax Liabilities, Net | $ 0 |
Note 12 - Related Party Trans46
Note 12 - Related Party Transactions (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Aug. 31, 2016 | Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 6,714,410 | |||
Share-based Compensation | $ 1,298,000 | $ 58,000 | ||
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 | 5,027,726 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||
Share-based Compensation | $ 184,000 | $ 306,000 | ||
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% |