BioCardia (BCDA) 10-Q 9 Nov 17 2017 Q3 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2017	Nov. 08, 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)		38,220,141
Document Type	10-Q
Document Period End Date	Sep. 30, 2017
Document Fiscal Year Focus	2,017
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016
Current assets:
Cash and cash equivalents	$ 13,326	$ 21,352
Accounts receivable, net of allowance for doubtful accounts of $3 and $2 at September 30, 2017 and December 31, 2016, respectively	90	74
Inventory	240	135
Short-term investments	1,799
Prepaid expenses	188	356
Total current assets	15,643	21,917
Property and equipment, net	163	111
Other assets	54	54
Total assets	15,860	22,082
Current liabilities:
Accounts payable	447	525
Accrued expenses and other current liabilities	1,393	848
Deferred revenue	160	71
Total current liabilities	2,000	1,444
Deferred rent	75	56
Total liabilities	2,075	1,500
Stockholders’ equity:
Preferred stock, $0.001 par value, 50,000,000 shares authorized; no shares issued and outstanding as of September 30, 2017 and December 31, 2016	0	0
Common stock, $0.001 par value, 750,000,000 shares authorized as of September 30, 2017 and December 31, 2016 respectively; 38,151,548 shares and 38,131,303 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively	38	38
Additional paid-in capital	82,711	80,686
Accumulated deficit	(68,964)	(60,142)
Total stockholders’ equity	13,785	20,582
Total liabilities and stockholders’ equity	$ 15,860	$ 22,082

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016
Allowance for doubtful accounts	$ 3	$ 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)	38,151,548	38,131,303
Common stock, shares outstanding (in shares)	38,151,548	38,131,303

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Revenue:
Net product revenue	$ 88,000	$ 100,000	$ 298,000	$ 406,000
Collaboration agreement revenue	42,000	17,000	81,000	33,000
Total revenue	130,000	117,000	379,000	439,000
Costs and expenses:
Cost of goods sold	147,000	196,000	525,000	578,000
Research and development	1,700,000	684,000	4,028,000	1,622,000
Selling, general and administrative	1,322,000	919,000	4,708,000	2,375,000
Total costs and expenses	3,169,000	1,799,000	9,261,000	4,575,000
Operating loss	(3,039,000)	(1,682,000)	(8,882,000)	(4,136,000)
Other income (expense):
Interest income	35,000		58,000
Interest expense	0	(520,000)	0	(1,627,000)
Change in fair value of convertible preferred stock warrant liability		30,000		250,000
Change in fair value of maturity date preferred stock warrant liability		3,000		10,000
Change in fair value of convertible shareholder notes derivative liability		(1,085,000)		(1,224,000)
Other expense	3,000		2,000	(1,000)
Total other income (expense), net	38,000	(1,572,000)	60,000	(2,592,000)
Net loss	$ (3,001,000)	$ (3,254,000)	$ (8,822,000)	$ (6,728,000)
Net loss per share, basic and diluted (in dollars per share)	$ (0.08)	$ (2.06)	$ (0.23)	$ (4.26)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	38,146,751	1,579,852	38,141,654	1,579,264

Condensed Consolidated Stateme5

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Operating activities:
Net loss	$ (8,822)	$ (6,728)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	57	30
Change in fair value of convertible preferred stock warrant liability		(250)
Change in fair value of maturity date preferred stock warrant liability		(10)
Change in fair value of convertible shareholder notes derivative liability		1,224
Stock based compensation	1,999	145
Non-cash interest expense on convertible shareholder notes		1,627
Changes in operating assets and liabilities:
Accounts receivable	(16)	45
Inventory	(105)	44
Prepaid expenses and other current assets	168	111
Accounts payable	(80)	505
Accrued liabilities excluding accrued interest on convertible note	545	235
Deferred revenue	89	37
Deferred rent	19	(22)
Net cash used in operating activities	(6,146)	(3,007)
Investing activities:
Purchase of property and equipment	(107)
Purchase of short-term investments	(1,799)
Net cash used in investing activities	(1,906)
Financing activities:
Proceeds from the exercise of common stock options	26	2
Net cash provided by financing activities	26	2
Net decrease in cash and cash equivalents	(8,026)	(3,005)
Cash and cash equivalents at beginning of period	21,352	3,557
Cash and cash equivalents at end of period	13,326	552
Supplemental disclosures for noncash investing activity:
Accounts payable recognized for the purchase of equipment	$ 2

Note 1 - Summary of Business an

Note 1 - Summary of Business and Basis of Presentation	9 Months Ended
	Sep. 30, 2017
Notes to Financial Statements
Business Description and Basis of Presentation [Text Block]	( 1 Summary 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 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 condensed consolidated financial statements, resulting in no As of September 30, 2017 December 31, 2016, ’s authorized share capital was 750 50 November 3, 2017, 100 25 ( 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 19.3678009 (approximately 1.6139834 November 3, 2017),

Note 2 - Significant Accounting

Note 2 - Significant Accounting Policies	9 Months Ended
	Sep. 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 and cash flows as of September 30, 2017 three nine September 30, 2017 2016 September 30, 2017, three nine September 30, 2017 2016, nine September 30, 2017 2016. three nine September 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 $69.0 September 30, 2017. $13.3 $1.8 September 30, 2017 third 2018. one not Our ability to continue as a going concern and to continue further development of the Company’s lead therapeutic candidate, the CardiAMP cell therapy system, and the Company’s second third 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 original 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, Financial Accounting Standards Board ( FASB) issued Accounting Standards Update ( ASU) 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 (g) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 In August 2015, No. 2015 14 December 15, 2017 December 15, 2016, not ’s customer contracts and the potential impacts the standard may In January 2016, FASB issued ASU No. 2016 01 2016 01 2016 01 January 1, 2018 not no may September 30, 2017, not 2016 01. 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. 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 ’s financial statement presentation or disclosures.

Note 3 - Fair Value Measurement

Note 3 - Fair Value Measurement	9 Months Ended
	Sep. 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 levels: 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 September 30, 2017 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash $ 2,093 $ — $ — $ 2,093 Money market instruments — 11,233 — 11,233 Total cash and cash equivalents $ 2,093 $ 11,233 $ — $ 13,326 Short term investments: US government securities $ — $ 1,799 $ — $ 1,799 Total short-term investments $ — $ 1,799 $ — $ 1,799 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, 20% 10% 81,460 48,223 6,788 4,018 November 3, 2017), n o warrants are outstanding as of September 30, 2017 December 31, 2016. In May 2015, $7.2 2015 Upon the completion of the Merger, the 2015 67,443,988 5,620,332 November 3, 2017). o notes are outstanding as of September 30, 2017 December 31, 2016. 8, 2015 September 30, 2016. 2015 not October 24, 2016.

Note 4 - Investments

Note 4 - Investments	9 Months Ended
	Sep. 30, 2017
Notes to Financial Statements
Investment [Text Block]	( 4 ) Investments The following table summarizes the estimated value of the Company ’s marketable securities and the gross unrealized gains and losses as of September 30, 2017 ( Amortized cost Unrealized gain Unrealized loss Estimated Fair Value US government securities $ 1,799 $ — $ — $ 1,799 Total short-term investments $ 1,799 $ — $ — $ 1,799 As of September 30, 2017, one no nine September 30, 2017.

Note 5 - Inventories

Note 5 - Inventories	9 Months Ended
	Sep. 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): September 30, 2017 December 31, 2016 Raw materials $ 74 $ 59 Work in process 87 — Finished goods 79 76 Total $ 240 $ 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 $15,000 $57,000 three September 30, 2017 2016, $25,000 $94,000 nine September 30, 2017 2016,

Note 6 - Property and Equipment

Note 6 - Property and Equipment, Net	9 Months Ended
	Sep. 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): September 30, 2017 December 31, 2016 Computer equipment and software $ 186 $ 143 Laboratory and manufacturing equipment 431 366 Furniture and fixtures 48 48 Leasehold improvements 326 325 Property and equipment, gross 991 882 Less accumulated depreciation (828 ) (771 ) Property and equipment, net $ 163 $ 111 Depreciation expense totaled approximately $21,000 $9,000 three September 30, 2017 2016, $57,000 $30,000 nine September 30, 2017 2016,

Note 7 - Accrued Expenses and O

Note 7 - Accrued Expenses and Other Current Liabilities	9 Months Ended
	Sep. 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): September 30, 2017 December 31, 2016 Accrued expenses $ 487 $ 478 Accrued clinical trial costs 175 — Grant liability 669 304 Customer deposits 62 66 Total $ 1,393 $ 848

Note 8 - Convertible Notes

Note 8 - Convertible Notes	9 Months Ended
	Sep. 30, 2017
Notes to Financial Statements
Debt Disclosure [Text Block]	( 8 ) Convertible Notes As of September 30, 2017, no In May 2015, BioCardia Lifesciences entered into note agreements with various stockholders of BioCardia Lifesciences and other lenders for a total of $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 ’s common stock (approximately 5,620,332 ) . The 2015 We estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model. The inputs used to determine the estimated fair value of the compound embedded derivative instrument include the probability of an underlying event triggering the redemption event and its timing prior to the maturity date of the 2015 not The Company recognized interest expense, including amortization of the debt discount of $0 $520,000 three September 30, 2017 2016, $0 $1.6 nine September 30, 2017 2016,

Note 9 - Share-based Compensati

Note 9 - Share-based Compensation	9 Months Ended
	Sep. 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 The Company will not 2002 2016, 2016 2016 2016 2016 Stock compensation attributable to manufacturing operations was not three nine September 30, 2017 2016 Three Months ended September 30, Nine Months ended September 30, 2017 2016 2017 2016 Cost of goods sold $ 33 $ - $ 107 $ 1 Research and development 172 30 498 30 Selling, general and administrative 496 57 1,394 114 Share-based compensation expense $ 701 $ 87 $ 1,999 $ 145 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 3,491,937 $ 1.78 Stock options granted 704,946 8.34 Stock options exercised (20,243 ) 2.08 Stock options cancelled (33,948 ) 0.48 Balance, September 30, 2017 4,142,692 $ 2.90 The weighted average grant-date fair value of options granted during the nine September 30, 2017 $6.44 Employee Share-Based Compensation (Stock Options) During the nine September 30, 2017, 542,631 Risk-free interest rate 1. 88 – 2. 13% Volatility 8 2 – 89% Dividend yield None Expected terms (in years) 5. 50 – 6.25 Unrecognized share-based compensation for employee options granted through September 30, 2017 $4.7 3.0 Non-Employee Director Share-Based Compensation (RSUs) During the nine September 30, 2017, 97,996 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 97,996 $ 8.71 RSUs vested — RSUs forfeited — Balance, September 30, 2017 97,996 $ 8.71 Unrecognized share-based compensation for employee RSUs granted through September 30, 2017 $642,000 2.0 Nonemployee Share-Based Compensation During the nine September 30, 2017, 162,315 $188,000 $20,000 three September 30, 2017 2016, $698,000 $21,000 nine September 30, 2017 2016, The Company accounts for share-based compensation arrangements with nonemployees, using the Black-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 for the nine September 30, 2017: Risk-free interest rate 2.25 – 2.2 9% Volatility 84 – 87% Dividend yield None Expected terms (in years) 8.9 – 9.5

Note 10 - Net Loss Per Share

Note 10 - Net Loss Per Share	9 Months Ended
	Sep. 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: September 30, 2017 2016 Convertible preferred stock - 9,208,376 Notes convertible into shares - 5,620,332 Convertible preferred stock warrants - 92,116 Stock options to purchase common stock 4,142,692 3,716,947 Unvested restricted stock units 97,996 - Total 4,240,688 18,637,771

Note 11 - Income Taxes

Note 11 - Income Taxes	9 Months Ended
	Sep. 30, 2017
Notes to Financial Statements
Income Tax Disclosure [Text Block]	( 11 ) Income Taxes During the nine September 30, 2017 2016, no As of September 30, 2017, not not

Note 12 - Related Party Transac

Note 12 - Related Party Transactions	9 Months Ended
	Sep. 30, 2017
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	( 1 2 ) Related Party Transactions In August 2016, purchase 5,027,726 418,977 November 3, 2017) 4 consideration for consulting services to be provided by OPKO in accordance with the consulting agreement entered into between the Company and OPKO. The unearned portion of the share-based compensation related to the OPKO option was revalued at September 30, 2017, $126,000 $432,000 three nine September 30, 2017, 4 one 5% 5%

Significant Accounting Policies

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 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 and cash flows as of September 30, 2017 three nine September 30, 2017 2016 September 30, 2017, three nine September 30, 2017 2016, nine September 30, 2017 2016. three nine September 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 $69.0 September 30, 2017. $13.3 $1.8 September 30, 2017 third 2018. one not Our ability to continue as a going concern and to continue further development of the Company’s lead therapeutic candidate, the CardiAMP cell therapy system, and the Company’s second third 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 original 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, Financial Accounting Standards Board ( FASB) issued Accounting Standards Update ( ASU) 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 (g) Recently Issued Accounting Pronouncements In May 2014, No. 2014 09, 606 2014 09 In August 2015, No. 2015 14 December 15, 2017 December 15, 2016, not ’s customer contracts and the potential impacts the standard may In January 2016, FASB issued ASU No. 2016 01 2016 01 2016 01 January 1, 2018 not no may September 30, 2017, not 2016 01. 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. 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 ’s financial statement presentation or disclosures.

Note 3 - Fair Value Measureme19

Note 3 - Fair Value Measurement (Tables)	9 Months Ended
	Sep. 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 $ 2,093 $ — $ — $ 2,093 Money market instruments — 11,233 — 11,233 Total cash and cash equivalents $ 2,093 $ 11,233 $ — $ 13,326 Short term investments: US government securities $ — $ 1,799 $ — $ 1,799 Total short-term investments $ — $ 1,799 $ — $ 1,799 Level 1 Level 2 Level 3 Total Assets: Cash $ 21,352 $ — $ — $ 21,352

Note 4 - Investments (Tables)

Note 4 - Investments (Tables)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Unrealized Gain (Loss) on Investments [Table Text Block]	Amortized cost Unrealized gain Unrealized loss Estimated Fair Value US government securities $ 1,799 $ — $ — $ 1,799 Total short-term investments $ 1,799 $ — $ — $ 1,799

Note 5 - Inventories (Tables)

Note 5 - Inventories (Tables)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Schedule of Inventory, Current [Table Text Block]	September 30, 2017 December 31, 2016 Raw materials $ 74 $ 59 Work in process 87 — Finished goods 79 76 Total $ 240 $ 135

Note 6 - Property and Equipme22

Note 6 - Property and Equipment, Net (Tables)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Property, Plant and Equipment [Table Text Block]	September 30, 2017 December 31, 2016 Computer equipment and software $ 186 $ 143 Laboratory and manufacturing equipment 431 366 Furniture and fixtures 48 48 Leasehold improvements 326 325 Property and equipment, gross 991 882 Less accumulated depreciation (828 ) (771 ) Property and equipment, net $ 163 $ 111

Note 7 - Accrued Expenses and23

Note 7 - Accrued Expenses and Other Current Liabilities (Tables)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block]	September 30, 2017 December 31, 2016 Accrued expenses $ 487 $ 478 Accrued clinical trial costs 175 — Grant liability 669 304 Customer deposits 62 66 Total $ 1,393 $ 848

Note 9 - Share-based Compensa24

Note 9 - Share-based Compensation (Tables)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Schedule of Share-based Compensation, Expense [Table Text Block]	Three Months ended September 30, Nine Months ended September 30, 2017 2016 2017 2016 Cost of goods sold $ 33 $ - $ 107 $ 1 Research and development 172 30 498 30 Selling, general and administrative 496 57 1,394 114 Share-based compensation expense $ 701 $ 87 $ 1,999 $ 145
Share-based Compensation, Stock Options, Activity [Table Text Block]	Options outstanding Weighted average Number of exercise shares price Balance, December 31, 2016 3,491,937 $ 1.78 Stock options granted 704,946 8.34 Stock options exercised (20,243 ) 2.08 Stock options cancelled (33,948 ) 0.48 Balance, September 30, 2017 4,142,692 $ 2.90
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 97,996 $ 8.71 RSUs vested — RSUs forfeited — Balance, September 30, 2017 97,996 $ 8.71
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 – 2.2 9% Volatility 84 – 87% Dividend yield None Expected terms (in years) 8.9 – 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. 13% Volatility 8 2 – 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)	9 Months Ended
	Sep. 30, 2017
Notes Tables
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	September 30, 2017 2016 Convertible preferred stock - 9,208,376 Notes convertible into shares - 5,620,332 Convertible preferred stock warrants - 92,116 Stock options to purchase common stock 4,142,692 3,716,947 Unvested restricted stock units 97,996 - Total 4,240,688 18,637,771

Note 1 - Summary of Business 26

Note 1 - Summary of Business and Basis of Presentation (Details Textual)	Nov. 01, 2017shares	Sep. 30, 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		750,000,000		750,000,000
Preferred Stock, Shares Authorized		50,000,000		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					19.3678009
Subsequent Event [Member]
Common Stock, Shares Authorized	100,000,000
Preferred Stock, Shares Authorized	25,000,000
Subsequent Event [Member] | Merger [Member]
Business Combination, Number of Shares of Post-merger Entity for Each Share of Pre-merger Entity	1.6139834
Reverse Stock Split [Member] | Subsequent Event [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	12

Note 2 - Significant Accounti27

Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016	Sep. 30, 2016	Dec. 31, 2015
Retained Earnings (Accumulated Deficit)	$ (68,964)	$ (60,142)
Cash and Cash Equivalents, at Carrying Value	13,326	21,352	$ 552	$ 3,557
Short-term Investments	$ 1,799

Note 3 - Fair Value Measureme28

Note 3 - Fair Value Measurement (Details Textual) - USD ($)	Nov. 01, 2017	Oct. 24, 2016	Sep. 30, 2017	Dec. 31, 2016	May 31, 2015
Warrants and Rights Outstanding			$ 0	$ 0
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
The 2015 Notes [Member] | Convertible Debt [Member] | Merger [Member]
Debt Conversion, Converted Instrument, Shares Issued		67,443,988
Subsequent Event [Member] | The 2015 Notes [Member] | Convertible Debt [Member] | Merger [Member]
Debt Conversion, Converted Instrument, Shares Issued after Effect of Reverse Stock Split	5,620,332
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		81,460
Warrant to Purchase Series D Convertible Preferred Stock [Member] | Subsequent Event [Member]
Stock Issued During Period, Shares, Exchange of Convertible Preferred Stock Warrants to Common Stock after Effect of Reverse Stock Split	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		48,223
Warrant to Purchase Series F Convertible Preferred Stock [Member] | Subsequent Event [Member]
Stock Issued During Period, Shares, Exchange of Convertible Preferred Stock Warrants to Common Stock after Effect of Reverse Stock Split	4,018

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	Sep. 30, 2017	Dec. 31, 2016
Marketable securities	$ 1,799
Fair Value, Measurements, Recurring [Member]
Cash and cash equivalents	13,326
Marketable securities	1,799
Fair Value, Measurements, Recurring [Member] | US Government Agencies Debt Securities [Member]
Marketable securities	1,799
Fair Value, Measurements, Recurring [Member] | Cash [Member]
Cash and cash equivalents	2,093	$ 21,352
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member]
Cash and cash equivalents	11,233
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member]
Cash and cash equivalents	2,093
Marketable securities
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | US Government Agencies Debt Securities [Member]
Marketable securities
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Cash [Member]
Cash and cash equivalents	2,093	21,352
Fair Value, Inputs, Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member]
Cash and cash equivalents
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member]
Cash and cash equivalents	11,233
Marketable securities	1,799
Fair Value, Inputs, Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | US Government Agencies Debt Securities [Member]
Marketable securities	1,799
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	11,233
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] | US Government Agencies 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

Note 4 - Investments (Details T

Note 4 - Investments (Details Textual) $ in Thousands	9 Months Ended
	Sep. 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	Sep. 30, 2017USD ($)
Marketable securities, amortized cost	$ 1,799
Marketable securities, unrealized gain
Marketable securities, unrealized loss
Marketable securities	1,799
US States and Political Subdivisions Debt Securities [Member]
Marketable securities, amortized cost	1,799
Marketable securities, unrealized gain
Marketable securities, unrealized loss
Marketable securities	$ 1,799

Note 5 - Inventories (Details T

Note 5 - Inventories (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Inventory Write-down	$ 15,000	$ 57,000	$ 25,000	$ 94,000

Note 5 - Inventories - Summary

Note 5 - Inventories - Summary of Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016
Raw materials	$ 74	$ 59
Work in process	87
Finished goods	79	76
Total	$ 240	$ 135

Note 6 - Property and Equipme34

Note 6 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Depreciation	$ 21,000	$ 9,000	$ 57,000	$ 30,000

Note 6 - Property and Equipme35

Note 6 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016
Property and equipment, gross	$ 991	$ 882
Less accumulated depreciation	(828)	(771)
Property and equipment, net	163	111
Computer Equipment and Software [Member]
Property and equipment, gross	186	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	$ 326	$ 325

Note 7 - Accrued Expenses and36

Note 7 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2017	Dec. 31, 2016
Accrued expenses	$ 487	$ 478
Accrued clinical trial costs	175
Grant liability	669	304
Customer deposits	62	66
Total	$ 1,393	$ 848

Note 8 - Convertible Notes (Det

Note 8 - Convertible Notes (Details Textual) - USD ($)	Nov. 01, 2017	Oct. 24, 2016	May 31, 2015	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Aug. 31, 2016
Notes Payable				$ 0		$ 0
Interest Expense				$ 0	$ 520,000	$ 0	$ 1,627,000
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
The 2015 Notes [Member] | Convertible Debt [Member] | Merger [Member] | Subsequent Event [Member]
Debt Conversion, Converted Instrument, Shares Issued after Effect of Reverse Stock Split	5,620,332

Note 9 - Share-based Compensa38

Note 9 - Share-based Compensation (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value			$ 6.44
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross			704,946
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options	$ 4,700,000		$ 4,700,000
Share-based Compensation			$ 1,999,000	$ 145,000
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]
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition			2 years
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	642,000		$ 642,000
Non-employee Directors and Employees [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross			542,631
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			97,996
Consultants [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross			162,315
Non-employees [Member]
Share-based Compensation	$ 188,000	$ 20,000	$ 698,000	$ 21,000

Note 9 - Share-based Compensa39

Note 9 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Share-based compensation expense	$ 701	$ 87	$ 1,999	$ 145
Cost of Goods Sold [Member]
Share-based compensation expense	33		107	1
Research and Development Expense [Member]
Share-based compensation expense	172	30	498	30
Selling, General and Administrative Expenses [Member]
Share-based compensation expense	$ 496	$ 57	$ 1,394	$ 114

Note 9 - Share-based Compensa40

Note 9 - Share-based Compensation - Stock Option Activity (Details)	9 Months Ended
	Sep. 30, 2017$ / sharesshares
Stock options outstanding, beginning of period (in shares) | shares	3,491,937
Balance, weighted average exercise price, beginning of period (in dollars per share) | $ / shares	$ 1.78
Stock options granted (in shares) | shares	704,946
Stock options granted (in dollars per share) | $ / shares	$ 8.34
Stock options exercised (in shares) | shares	(20,243)
Stock options exercised, weighted average exercise price (in dollars per share) | $ / shares	$ 2.08
Stock options cancelled (in shares) | shares	(33,948)
Stock options cancelled, weighted average exercise price (in dollars per share) | $ / shares	$ 0.48
Stock options outstanding, end of period (in shares) | shares	4,142,692
Balance, weighted average exercise price, end of period (in dollars per share) | $ / shares	$ 2.90

Note 9 - Share-based Compensa41

Note 9 - Share-based Compensation - Valuation Assumptions for Employee Stock Options (Details) - Employee Stock Option [Member]	9 Months Ended
	Sep. 30, 2017
Risk-free interest rate, minimum	1.88%
Risk-free interest rate, maximum	2.13%
Volatility, minimum	82.00%
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]	9 Months Ended
	Sep. 30, 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 9 - Share-based Compensa43

Note 9 - Share-based Compensation - Nonemployee Stock Option Valuation Assumptions (Details) - Non-employee Stock Options [Member]	9 Months Ended
	Sep. 30, 2017
Risk-free interest rate, minimum	2.25%
Risk-free interest rate, maximum	2.29%
Volatility, minimum	84.00%
Volatility, maximum	87.00%
Dividend yield	0.00%
Minimum [Member]
Expected terms (Year)	8 years 328 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	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Antidilutive securities (in shares)	4,240,688	18,637,771
Convertible Preferred Stock [Member]
Antidilutive securities (in shares)		9,208,376
Convertible Debt Securities [Member]
Antidilutive securities (in shares)		5,620,332
Warrant [Member]
Antidilutive securities (in shares)		92,116
Employee Stock Option [Member]
Antidilutive securities (in shares)	4,142,692	3,716,947
Restricted Stock Units (RSUs) [Member]
Antidilutive securities (in shares)	97,996

Note 11 - Income Taxes (Details

Note 11 - Income Taxes (Details Textual) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2017	Sep. 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 ($)	Nov. 01, 2017	Aug. 31, 2016	Sep. 30, 2017	Sep. 30, 2017	Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross				704,946
Share-based Compensation				$ 1,999,000	$ 145,000
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			$ 126,000	$ 432,000
Consulting Agreement, Term		4 years
Consulting Agreement, Term, Length of Automatic Renewal Periods		1 year
OPKO [Member] | Consulting Services [Member] | Subsequent Event [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period after Effect of Reverse Stock Split	418,977
Chairman and Chief Executive Officer of OPKO [Member]
Related Party, Ownership Percentage		5.00%