10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2017

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 0-21419

BioCardia, Inc.

(Exact name of registrant as specified in its charter)

Delaware	23-2753988
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

125 Shoreway Road, Suite B 

San Carlos, California 94070

(Address of principal executive offices)

(650) 226-0120

Registrant’s telephone number, including area code

N/A

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☐  (Do not check if a smaller reporting company)	Smaller reporting company	☒

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No  ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

There were 457,682,784 shares of the registrant’s Common Stock issued and outstanding as of May 9, 2017.

Part I.   FINANCIAL INFORMATION		1
Item 1.	Unaudited Condensed Consolidated Financial Statements	1
	Condensed Consolidated Balance Sheets as of March 31, 2017 and December 31, 2016	1
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2017 and 2016	2
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2017 and 2016	3
	Notes to Unaudited Condensed Consolidated Financial Statements	4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	15
Item 4.	Controls and Procedures	15
Part II.  OTHER INFORMATION		17
Item 1.	Legal Proceedings	17
Item 1A.	Risk Factors	17
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	17
Item 3.	Defaults Upon Senior Securities	17
Item 4.	Mine Safety Disclosures	17
Item 5.	Other Information	17
Item 6.	Exhibits	17
SIGNATURES		18
EXHIBIT INDEX		19

FORWARD-LOOKING INFORMATION

This report contains forward-looking statements within the meaning of the U.S. federal securities laws that involve risks and uncertainties. Certain statements contained in this report are not purely historical including, without limitation, statements regarding our expectations, beliefs, intentions, anticipations, commitments or strategies regarding the future that are forward-looking. These statements include those discussed in Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including “Critical Accounting Policies and Estimates,” “Results of Operations,” “Liquidity and Capital Resources,” and “Future Funding Requirements,” and elsewhere in this report.

In this report, the words “may,” “could,” “would,” “might,” “will,” “should,” “plan,” “ forecast,” “anticipate,” “believe,” “expect,” “intend,” “estimate,” “predict,” “potential,” “continue,” “future,” “moving toward” or the negative of these terms or other similar expressions also identify forward-looking statements. Our actual results could differ materially from those forward-looking statements contained in this report as a result of a number of risk factors including, but not limited to, those listed in our Annual Report on Form 10-K and elsewhere in this report. You should carefully consider these risks, in addition to the other information in this report and in our other filings with the SEC. All forward-looking statements and reasons why results may differ included in this report are made as of the date of this report, and we assume no obligation to update any such forward-looking statement or reason why such results might differ, except as required by law.

PART I. FINANCIAL INFORMATION

ITEM 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

BIOCARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

Assets	March 31, 2017			December 31, 2016
	(unaudited)
Current assets:
Cash and cash equivalents	$	19,032		$	21,352
Accounts receivable, net of allowance for doubtful accounts of $1 and $2 at March 31, 2017 and December 31, 2016, respectively		121			74
Inventory		144			135
Prepaid expenses		252			356
Total current assets		19,549			21,917
Property and equipment, net		177			111
Other assets		54			54
Total assets	$	19,780		$	22,082
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	291		$	525
Accrued liabilities		720			544
Deferred revenue		72			71
Grant liability		285			304
Total current liabilities		1,368			1,444
Deferred rent		62			56
Total liabilities		1,430			1,500
Stockholders’ equity:
Preferred stock, $0.001 par value, 50,000,000 shares authorized, no shares issued and outstanding at March 31, 2017 and December 31, 2016		—			—
Common stock, $0.001 par value, 750,000,000 shares authorized at March 31, 2017 and December 31, 2016, 457,682,784 shares and 457,575,631 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively		458			458
Additional paid-in capital		80,910			80,266
Accumulated deficit		(63,018	)		(60,142	)
Total stockholders’ equity		18,350			20,582
Total liabilities and stockholders’ equity	$	19,780		$	22,082

See accompanying notes to condensed consolidated financial statements.

1

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

	Three Months ended March 31,
	2017			2016
Revenue:
Net product revenue	$	109		$	168
Collaboration agreement revenue		28			10
Total revenue		137			178
Costs and expenses:
Cost of goods sold		175			226
Research and development		1,033			441
Selling, general and administrative		1,804			587
Total costs and expenses		3,012			1,254
Operating loss		(2,875	)		(1,076	)
Other income (expense):
Interest expense, net		—			(550	)
Change in fair value of convertible preferred stock warrant liability		—			53
Change in fair value of maturity date preferred stock warrant liability		—			(1	)
Change in fair value of convertible shareholder notes derivative liability		—			78
Other expense		(1	)		—
Total other expense, net		(1	)		(420	)
Net loss	$	(2,876	)	$	(1,496	)
Net loss per share, basic and diluted	$	(0.01	)	$	(0.08	)
Weighted-average shares used in computing net loss per share, basic and diluted		457,654,570			18,947,536

See accompanying notes to condensed consolidated financial statements.

2

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

	Three Months ended March 31,
	2017			2016
Operating activities:
Net loss	$	(2,876	)	$	(1,496	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		13			10
Change in fair value of convertible preferred stock warrant liability		—			(53	)
Change in fair value of maturity date preferred stock warrant liability		—			1
Change in fair value of convertible shareholder notes derivative liability		—			(78	)
Share-based compensation		622			30
Non-cash interest expense on convertible shareholder notes		—			550
Changes in operating assets and liabilities:
Accounts receivable		(47	)		(4	)
Inventory		(9	)		42
Prepaid expenses		104			28
Accounts payable		(249	)		103
Accrued liabilities excluding accrued interest on convertible note		176			86
Deferred revenue		1			40
Deferred rent		6			(7	)
Grant liability		(19	)		—
Net cash used in operating activities		(2,278	)		(748	)
Investing activities:
Purchase of property and equipment		(64	)		—
Net cash used in investing activities		(64	)		—
Financing activities:
Proceeds from the exercise of stock options		22			—
Net cash provided by financing activities		22			—
Net decrease in cash and cash equivalents		(2,320	)		(748	)
Cash and cash equivalents at beginning of period		21,352			3,557
Cash and cash equivalents at end of period	$	19,032		$	2,809
Supplemental disclosures for noncash investing activity:
Accounts payable recognized for the purchase of equipment	$	15		$	—

See accompanying notes to condensed consolidated financial statements.

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(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 therapeutic candidate is the CardiALLO cell therapy system. To date the Company has devoted substantially all of its resources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting its intellectual property.

The Company has three enabling device product lines: (1) the CardiAMP cell processing system; (2) the Helix biotherapeutic delivery system, or Helix; and (3) the Morph vascular access product line, or Morph, which offers advanced catheter products for interventional medicine. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

(b) Reverse Merger

On August 22, 2016, the Company, its wholly-owned subsidiary, Icicle Acquisition Corp, and BioCardia Lifesciences, Inc., or BioCardia Lifesciences (at the time named BioCardia, Inc.), entered into an Agreement and Plan of Merger, or the Merger Agreement. The transactions contemplated by the Merger Agreement closed on October 24, 2016, pursuant to which Icicle Acquisition Corp. merged with and into BioCardia Lifesciences, with BioCardia Lifesciences continuing as the surviving company, or the Merger. BioCardia Lifesciences was determined to be the accounting acquirer in the Merger based upon the terms of the Merger and other factors, including: (i) former BioCardia Lifesciences security holders owned approximately 54% of the combined company (on a fully diluted basis) immediately following the closing of the Merger, (ii) former BioCardia Lifesciences directors hold the majority of the board seats in the combined company, and (iii) former BioCardia Lifesciences management holds all of the key positions in the management of the combined company. Following the completion of the Merger, the Company changed its name to BioCardia, Inc.

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 shares of Company common stock, or the Exchange Ratio. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the capital structure as a result of the Merger.

(2) Significant Accounting Policies

(a) Basis of Preparation

The accompanying condensed consolidated balance sheets, statements of operations and cash flows as of March 31, 2017 and for the three months ended March 31, 2017 and 2016 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of March 31, 2017, results of operations and cash flows for the three months ended March 31, 2017 and 2016. The results for the three months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other interim period or for any other future year.

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-K for the year ended December 31, 2016, filed with the SEC on March 30, 2017.

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(b) Liquidity

The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $63.0 million as of March 31, 2017. Management expects operating losses and negative cash flows to continue through at least the next several years.

Upon closing of the Merger Agreement, the combined company had approximately $24.0 million in cash, including $19.0 million of cash acquired as part of the Merger and $4.4 million in net proceeds from the issuance of convertible notes in October 2016. Management believes cash of $19.0 million as of March 31, 2017 is sufficient to fund the Company for at least the next twelve-month period following the date of issuance of these financial statements. The Company also plans to raise other additional capital, potentially including debt and equity arrangements, to finance its future operations. If adequate funds are not available, the Company may be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that may require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations. While the Company believes in the viability of its strategy to raise additional funds, there can be no assurances to that effect.

(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 of the notes to the financial statements included in the 2016 Form 10-K. There have been no changes to those policies except as described below.

(f) Recently Adopted Accounting Pronouncement

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (ASU 2016-09). The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification in the statement of cash flows and forfeitures. The Company adopted ASU 2016-09 effective January 1, 2017.

The impact of adopting ASU 2016-09 resulted in the following:

● We will classify 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 material impact to our condensed consolidated financial statements due to a full valuation allowance recognized against our deferred tax assets.

● 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 result in changes in our condensed consolidated statements of cash flow.

There were no other material impacts to our condensed consolidated financial statements as a result of adopting this updated standard.

5

(g) Recently Issued Accounting Pronouncements

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides comprehensive guidance for revenue recognition. ASU 2014-09 affects any entity which either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. The core principle of the guidance provides that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The new standard can be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of the change recognized at the date of the initial application in retained earnings.

In August 2015, the FASB issued ASU 2015-14 Revenue from Contracts with Customers, which deferred the effective date for implementation of the standard. Public entities are to apply the new standard for annual and interim reporting periods beginning after December 15, 2017 and earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company has not elected early adoption and has not concluded on an adoption method. The Company has formed a task force that is beginning to assess the Company’s customer contracts and the potential impacts the standard may have on previously reported revenues and future revenues. Given the relatively small volume of revenue arrangements, the Company believes that the analysis will be completed in sufficient time to adopt the new standard when required.

In February 2016, the FASB issued ASU 2016-02 Leases (Topic 842), which supersedes existing guidance on accounting for leases in “Leases (Topic 840)” and generally requires all leases to be recognized in the consolidated balance sheet. ASU 2016-02 is effective for annual and interim reporting periods beginning after December 15, 2018; early adoption is permitted. The Company does not plan to elect early adoption. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on the Company’s financial statement presentation or disclosures.

(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 – quoted prices in active markets for identical assets and liabilities

Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities

Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table sets forth the fair value of our financial assets measured on a recurring basis as of March 31, 2017 and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	19,032	$	—	$	—	$	19,032

The following table sets forth the fair value of our financial assets measured on a recurring basis as of December 31, 2016 and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	21,352	$	—	$	—	$	21,352

As discussed in Note 7, in 2015, the Company issued warrants to purchase preferred stock in connection with the note agreements to various shareholders as described below. The warrant liabilities were recorded at the fair value on the date of issuance and were remeasured each subsequent balance sheet date and as of the warrant exercise date, with fair value changes recognized as income (decrease in fair value) or expense (increase in fair value) in other income (expense) in the consolidated statements of operations.  No warrants are outstanding as of March 31, 2017.

6

In May 2015, the Company entered into note agreements with various stockholders of the Company and other lenders for a total of $7.2 million, or the 2015 Notes. As discussed more fully in Note 7, the 2015 Notes include embedded derivative features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The Company estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model from inception through June 30, 2016. 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 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Upon the completion of the Merger, the valuation of the compound embedded derivative was determined based on the settlement value of the common stock exchanged for the notes on October 24, 2016.  No notes are outstanding as of March 31, 2017.

(4) 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):

	March 31, 2017		December 31, 2016
Raw materials	$	53	$	59
Work in process		48		—
Finished goods		43		76
Total	$	144	$	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 result in recording additional write downs for excess or expired inventory in the future. Charges to cost of goods sold for inventory write-downs, scrap, shrinkage and expired inventories totaled approximately $9,000 and $18,000 for the three months ended March 31, 2017 and 2016, respectively.

(5) Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):

	March 31, 2017			December 31, 2016
Computer equipment and software	$	172		$	143
Laboratory and manufacturing equipment		415			366
Furniture and fixtures		48			48
Leasehold improvements		326			325
Property and equipment, gross		961			882
Less accumulated depreciation		(784	)		(771	)
Property and equipment, net	$	177		$	111

Depreciation expense totaled approximately $13,000 and $10,000 for the three months ended March 31, 2017 and 2016, respectively.

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(6) Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

	March 31, 2017		December 31, 2016
Accrued expenses	$	572	$	478
Accrued clinical trial costs		86		—
Customer deposits		62		66
Total	$	720	$	544

(7) Convertible Notes

In May 2015, BioCardia Lifesciences entered into note agreements with various stockholders of BioCardia Lifesciences and other lenders for a total of $7.2 million, or the 2015 Notes. The 2015 Notes accrued 8% annual simple interest, matured 18 months from the issue date and were callable after the maturity date by written demand of a majority of the holders of the outstanding note principle. If BioCardia Lifesciences closed an effective registration statement filed under the Securities Act of 1933, as amended, covering the sale of BioCardia Lifesciences common stock (an IPO) prior to maturity, the outstanding principle and accrued interest would have automatically converted into shares of common stock at 80% of the price of the shares of common stock purchased in the IPO. If at any time prior to the maturity date, the Company closed a private placement of the Company’s preferred stock for aggregate sales proceeds of at least $5.0 million excluding note conversions, at the note holder’s option, or the Optional Conversion Right, the outstanding principle and interest may have been converted into shares of the preferred stock at a conversion price equal to 80% of the price of the preferred shares sold in such financing, plus preferred stock warrant coverage equal to 8% with an exercise price equal to the purchase price of the preferred stock sold in such financing. If the notes were held to maturity, subject to BioCardia Lifesciences authorizing sufficient shares of a new class of preferred stock, or the Maturity Date Preferred Stock, the holder would have had the option to convert the outstanding principle and interest to this new class of Maturity Date Preferred Stock at an exercise price of $0.07 per share, plus 8% warrant coverage.

In August 2016, the Company and the holders of the 2015 Notes amended the 2015 Notes, pursuant to which the outstanding principal amount and all accrued interest through August 31, 2016 automatically converted into shares of BioCardia Lifesciences common stock at 80% of the conversion price of the convertible notes issued in October 2016. In addition, the amendment eliminated the payment of interest for the period subsequent to August 31, 2016, and through the date of the closing of the Merger. Upon the completion of the Merger, the 2015 Notes and accrued interest converted into shares of BioCardia Lifesciences common stock, which were then exchanged at the Exchange Ratio into 67,443,988 shares of the Company’s common stock.

The 2015 Notes had redemption features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The changes in the estimated value are reflected in the change in fair value of convertible shareholder notes derivative liability in the consolidated statements of operations. 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 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Immediately prior to the closing of the Merger, the compound embedded derivative was remeasured based on the settlement value of the common stock exchanged for the notes, and we reclassified the balance of the convertible shareholder notes derivative liability to additional paid-in capital.

The Company recognized interest expense, including amortization of the debt discount of approximately $0 and $550,000 for the three months ended March 31, 2017 and 2016, respectively. 

(8) Share-Based Compensation

BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2002 Stock Plan in 2002, or the 2002 Plan, and the Company assumed the 2002 Plan in the Merger. We will not grant any additional awards under the 2002 Plan following the Merger. In 2016, BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2016 Equity Incentive Plan, or the 2016 Plan, and the Company assumed the 2016 Plan in the Merger. We will grant awards, including incentive stock options and nonstatutory stock options, under the 2016 Plan following the Merger.

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Stock compensation attributable to manufacturing operations was not significant and was expensed directly to cost of goods sold in the condensed consolidated statements of operations. Share-based compensation expense for the three months ended March 31, 2017 and 2016 was recorded as follows (in thousands):

	Three Months ended March 31,
	2017		2016
Cost of goods sold	$	41	$	1
Research and development		172		1
Selling, general and administrative		409		28
Share-based compensation expense	$	622	$	30

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		4,413,930			0.90
Stock options exercised		(107,153	)		0.20
Stock options cancelled		(407,382	)		0.04
Balance, March 31, 2017		45,803,123		$	0.22

The weighted average grant-date fair value of options granted during the three months ended March 31, 2017 was $0.72 per share.

Employee Share-Based Compensation (Stock Options)

During the three months ended March 31, 2017, the Company granted stock options to certain non-employee directors and employees to purchase 2,466,147 shares of common stock. The fair value of each option grant is estimated on the date of the grant using the BSM option pricing model with the weighted average assumptions in the table below.  

Risk-free interest rate	2.05	–	2.07%
Volatility	88	–	89%
Dividend yield		None
Expected terms (in years)	6.00	–	6.25

Unrecognized share-based compensation for employee options granted through March 31, 2017 is approximately $4.1 million to be recognized over a remaining weighted average service period of 3.4 years.

Employee Share-Based Compensation (RSUs)

During the three months ended March 31, 2017, the Company granted to certain non-employee directors 736,000 restricted stock units, or RSUs. The fair value of each RSU is estimated on the closing market price on the grant date.  

The following summarizes the activity of non-vested RSUs:

			Weighted
			average
			grant date
	Number of		fair value
	shares		per share
Non-vested units, December 31, 2016		—
RSUs granted		736,000	$	0.92
RSUs vested		—
RSUs forfeited		—
Non-vested units, March 31, 2017		736,000	$	0.92

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Unrecognized share-based compensation for employee RSUs granted through March 31, 2017 is approximately $630,000 to be recognized over a remaining weighted average service period of 2.8 years.

Nonemployee Share-Based Compensation

During the three months ended March 31, 2017, the Company granted options to purchase 1,947,783 shares of common stock to consultants. These options were granted in exchange for consulting services to be rendered and vest over the term specified in the grant, which correlates to the period the services are rendered. The Company recorded approximately $233,000 and $1,000 for the three months ended March 31, 2017 and 2016, respectively, as nonemployee share-based compensation expense.

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 March 31, 2017:

Risk-free interest rate	2.37	–	2.40%
Volatility		89%
Dividend yield		None
Expected terms (in years)	9.4	–	9.8%

(9) 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:

	March 31,
	2017		2016
Stock options to purchase common stock		45,803,123		12,595,578
Unvested restricted stock units		736,000		-
Total		46,539,123		12,595,578

(10)     Income Taxes

During the three months ended March 31, 2017 and 2016, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statement of operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets.

As of March 31, 2017, the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of the Company’s deferred tax assets depends primarily on its ability to generate future taxable income which is uncertain. The Company does not believe that its deferred tax assets are realizable on a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.

(11)     Grant Funding

In June 2016, the Company entered into a grant agreement with Maryland Technology Development Corporation, or TEDCO. TEDCO was created by the Maryland State Legislature in 1998 to facilitate the transfer and commercialization of technology from Maryland’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 to exceed $750,000 to be used solely to finance the costs to conduct the research project entitled “Heart Failure Trial” over a period of three years. 

In the fourth quarter of 2016, the Company received approximately $312,000 under the grant which will be accounted for as a reduction to research and development expenses as the related qualifying costs are incurred. Approximately $27,000 of the qualifying costs had been incurred as of March 31, 2017. The remaining $285,000 is recorded as grant liability on the condensed consolidated balance sheet at March 31, 2017. The amount is recorded as a liability as the amounts are refundable, should a default by the Company, as defined in the agreement, occur prior to incurring the qualifying costs.

(12)     Related Party Transactions

In August 2016, the Company granted an option to purchase 5,027,726 shares of common stock, with 4-year vesting period and the exercise price of $0.15 per share, to OPKO Health, Inc., or OPKO, as 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 March 31, 2017, and the Company recorded $122,000 as expense during the three months ended March 31, 2017. The term of the consulting agreement is 4 years and will be automatically renewed for successive one year periods. The chairman and chief executive officer of OPKO is a beneficial owner of more than 5% of the outstanding shares of the Company’s common stock and OPKO itself is also a beneficial owner of more than 5% of the outstanding shares of the Company’s common stock. 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains certain forward-looking statements that involve risk and uncertainties. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those listed in our Annual Report on Form 10-K and elsewhere in this report. Historical results are not necessarily indicative of future results.

Special Note Regarding Smaller Reporting Company Status

We are filing this Quarterly Report on Form 10-Q as a “smaller reporting company” (as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended) based on our public float (the aggregate market value of our common equity held by non-affiliates of the Company) as of the last business day of our second fiscal quarter of 2016. As a result of being a smaller reporting company, we are allowed and have elected to omit certain information, including tabular disclosure of contractual obligations, from this Management’s Discussion and Analysis of Financial Condition and Results of Operations; however, we have provided all information for the periods presented that we believe to be appropriate and necessary.

Overview

We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Our lead therapeutic candidate is the CardiAMP Cell Therapy System, or CardiAMP. We have initiated our U.S. Food and Drug Administration, or FDA, accepted Phase III pivotal trial for CardiAMP in ischemic systolic heart failure, began treating patients in February 2017 and expect to obtain top-line data in 2019. If our trial is successful, we believe we will be the first company to reach the market with a cell-based therapy to treat heart failure. An Investigational Device Exemption submission to FDA for CardiAMP in the indication of post myocardial indication is anticipated in 2017. Our second therapeutic candidate is the CardiALLO Cell Therapy System, or CardiALLO. We anticipate preparation of an Investigational New Drug, or IND, application for submission to the FDA for a Phase II trial for CardiALLO for the treatment of ischemic systolic heart failure. This IND is expected to have improved Chemistry Manufacturing Controls, or CMC, in the IND relative to our previous co-sponsored investigations. We are committed to applying our expertise in the fields of autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular conditions.

To date, we have devoted substantially all of our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems, including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property. We have also generated modest revenues from sales of our approved products. We have funded our operations primarily through the sales of equity and convertible debt securities, and certain government and private grants. All convertible debt securities were converted into shares of our Common Stock in connection with the Merger.

We have incurred net losses in each year since our inception. Our net losses were approximately $2.9 million and $1.5 million for the three months ended March 31, 2017 and 2016, respectively. As of March 31, 2017, we had an accumulated deficit of approximately $63.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs, clinical trials, intellectual property matters, building our manufacturing and sales capabilities, and from general and administrative costs associated with our operations.

Financial Overview

Revenue

We currently have a portfolio of enabling and delivery products, from which we have generated modest revenue.

Cost of Goods Sold

Cost of goods sold includes the costs of raw materials and components, manufacturing personnel and facility costs and other indirect and overhead costs associated with manufacturing our enabling and delivery products.

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Research and Development Expenses

Our research and development expenses consist primarily of:

• salaries and related overhead expenses, which include share-based compensation and benefits for personnel in research and development functions;

• fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial material management and statistical compilation and analysis;

• costs related to acquiring and manufacturing clinical trial materials;

• costs related to compliance with regulatory requirements; and

• payments related to licensed products and technologies.

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are performed.

We plan to increase our research and development expenses for the foreseeable future as we continue to develop CardiAMP, and subject to the availability of additional funding, further advance the development of CardiALLO and any other therapeutic candidates for additional indications. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly we have not historically allocated resources specifically to our individual programs.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our therapeutic candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our therapeutic candidates.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other significant selling, general and administrative expenses include sales commissions, rent, accounting and legal services, obtaining and maintaining patents, the cost of consultants, occupancy costs, insurance premiums and information systems costs.

We expect that our selling, general and administrative expenses will increase as we advance our Phase III pivotal heart failure trial for CardiAMP, and subject to the availability of additional funding, conduct our Phase II trial for CardiALLO and prepare for commercialization. We believe that these increases will likely include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel to support product commercialization efforts and operations and increased fees for outside consultants, attorneys and accountants. We also expect to incur increased costs to comply with corporate governance, internal controls, investor relations and disclosures, and similar requirements applicable to public companies.

Other Income (Expense)

Other income and expense consists primarily of interest income we earn on our cash and cash equivalents, interest charges we incurred in periods when we have convertible debt outstanding, and changes in the fair value of our warrant and convertible shareholder note derivative liabilities in periods when we have warrants or convertible debt outstanding. Subsequent to the Merger we have no interest charges related to the convertible debt and changes in the fair value of our warrant and convertible shareholder note derivative liabilities as such instruments were converted, cancelled or exchanged as part of the Merger. We expect our interest income to increase following the completion of the Merger as we invest our cash on hand pending its use in our operations.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported expenses during the periods presented. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. 

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Other than below, there were no material changes in our critical accounting estimates or accounting policies described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2016 Form 10-K during the three months ended March 31, 2017.

Share-Based Compensation 

We measure and recognize share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. We use the Black-Scholes-Merton option-pricing model, or BSM, to calculate the fair value of stock options. Restricted stock units (RSUs) are measured based on the fair market values of the underlying stock on the dates of grant. Share-based compensation expense recognized in the statements of operations is based on awards at the time of grant, and is reduced for actual forfeitures at the time that the forfeitures occur. Compensation cost for employee share-based awards will be recognized over the vesting period of the applicable award on a straight-line basis. 

For options granted to nonemployees, we revalue the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the statements of operations over the period the related services are rendered.

The BSM option-pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of our 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. 

Results of Operations

The following table summarizes our results of operations for the three months ended March 31, 2017 and 2016 (in thousands):

	Three Months Ended March 31,
	2017			2016
Revenue:
Net product revenue	$	109		$	168
Collaboration agreement revenue		28			10
Total revenue		137			178
Cost and expenses:
Cost of goods sold		175			226
Research and development		1,033			441
Selling, general and administrative		1,804			587
Total cost and expenses		3,012			1,254
Operating loss		(2,875	)		(1,076	)
Interest expense		-			(550	)
Other (expense) income		(1	)		130
Net loss	$	(2,876	)	$	(1,496	)

Revenue.     Revenue decreased by approximately $41,000 in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 primarily due to a reduction in sales volumes. We expect net product revenue for 2017 to be relatively consistent with 2016.

Cost of Goods Sold.    Cost of goods sold decreased by approximately $51,000 in the three months ended March 31, 2017 compared to the three months ended March 31 2016 consistent with the reduction in revenue. We expect cost of goods sold for 2017 to be relatively consistent with 2016.

Research and Development Expenses.     Research and development expenses increased by approximately $592,000 in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 primarily due to expenses incurred in the planning, preparation and inception of the CardiAMP Phase III pivotal heart failure trial. We expect research and development expenses to increase as we continue to enroll and treat patients in the trial and incur additional development expenses related to CardiALLO therapeutic program. 

Selling, General and Administrative Expenses.    Selling, general and administrative expenses increased by approximately $1.2 million in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 primarily due to the additional expense of operating as a public company, including additional salary expenses, stock compensation costs, legal, accounting, tax and other corporate expenses. We expect selling, general and administrative expenses for the remaining quarters to increase moderately from the three month period ended March 31, 2017 as we continue to build the supporting staff and infrastructure to support the CardiAMP Phase III pivotal trial and public company operations.  

Interest Expense.   Interest expense for the three months ended March 31, 2016 consisted primarily of interest expense related to convertible notes which are no longer outstanding.

Other Income (Expense). Other income (expense) for the three months ended March 31, 2016 consisted primarily of the changes in value of the convertible preferred stock warrant liabilities and the change in value of the convertible shareholder note derivative liability.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of March 31, 2017, we had an accumulated deficit of approximately $63.0 million. We anticipate that we will continue to incur net losses for at least the next several years.

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We have funded our operations principally through the sales of equity and convertible debt securities as well as the cash acquired through the Merger. As of March 31, 2017, we had cash and cash equivalents of approximately $19.0 million.

The following table shows a summary of our cash flows for the periods indicated (in thousands):

	Three Months Ended March 31,
	2017			2016
Net cash provided by (used in):
Operating activities	$	(2,278	)	$	(748	)
Investing activities		(64	)		-
Financing activities		22			-
Net decrease in cash and cash equivalents	$	(2,320	)	$	(748	)

Cash Flows from Operating Activities.    The increase in overall spending for operating activities of approximately $1.5 million in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 relates primarily to increased cash outflows to conduct the CardiAMP Phase III pivotal trial, further develop the CardiAMP and CardiALLO programs and to build the supporting infrastructure to sustain these efforts and support operations as a public company.   

Cash Flows from Investing Activities.     Net cash used in investing activities of $64,000 during the three months ended March 31, 2017 consists of the purchase of property and equipment.

Cash Flows from Financing Activities.     Net cash provided by financing activities of $22,000 during the three months ended March 31, 2017 consists of the proceeds from the exercise of stock options.

Future Funding Requirements

To date, we have generated modest revenue from sales of our approved products. We do not know when, or if, we will generate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our CardiAMP or CardiALLO therapeutic candidates unless and until we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations.  

Based upon our current operating plan, we believe that the cash on hand of $19.0 million as of March 31, 2017 will enable us to fund our operations for at least 12 months from the date of issuance of these financial statements. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.  

Our future capital requirements will depend on many factors, including:

• the progress, costs, results and timing of our CardiAMP and CardiALLO clinical trials;

• FDA acceptance of our CardiAMP and CardiALLO therapies for heart failure and for other potential indications;

• the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

• the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;

• the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;

• the ability of our product candidates to progress through clinical development successfully;

• our need to expand our research and development activities;

• the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;

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• our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

• the general and administrative expenses related to being a public company;

• our need and ability to hire additional management and scientific, medical and sales personnel;

• the effect of competing technological and market developments; and

• our need to implement additional internal systems and infrastructure, including financial and reporting systems.

Until such time that we can generate meaningful revenue from the sales of approved therapies and products, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our Common Stock holders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our Common Stock holders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, products or therapeutic candidates or to grant licenses on terms that may not be favorable to us. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research and development programs or the commercialization of any approved therapies or products or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition and results of operations.

Off-Balance Sheet Arrangements

During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the Securities and Exchange Commission.

Recent Accounting Pronouncements

See Note 2 of our notes to condensed consolidated financial statements for information regarding recent accounting pronouncements that are of significance or potential significance to us.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer and Vice President of Finance, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as the Company’s controls are designed to do, and management necessarily was required to apply its judgment in evaluating the risk related to controls and procedures.

In connection with the preparation of this Quarterly Report on Form 10-Q, as of March 31, 2017, an evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer and Vice President of Finance, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Due to the material weakness in internal control over financial reporting described in our Annual Report on 10-K for the fiscal year end dated December 31, 2016, our Chief Executive Officer and Vice President of Finance concluded that our disclosure controls and procedures were not effective as of March 31, 2017. These conclusions were communicated to the Audit Committee. Notwithstanding the existence of this material weakness, management has concluded that the condensed consolidated financial statements in this Form 10-Q fairly present, in all material respects, the Company’s financial position, results of operations and cash flows for all periods and dates presented.

15

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the three month period covered by this Quarterly Report on Form 10-Q that have materially affected or is reasonably likely to materially affect, our internal control over financial reporting.

16

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

The Company may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management does not believe that the Company is party to any currently pending legal proceedings. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows.

ITEM 1A. RISK FACTORS

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016, which could materially affect our business, financial condition, or future results. The risks described in this report and in our Annual Report on 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBIT INDEX

The exhibits listed in the Exhibit Index to this Quarterly Report on Form 10-Q are incorporated herein by reference.

17

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	BIOCARDIA, INC. (Registrant)
Date:     May 11, 2017	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)

18

EXHIBIT INDEX

Exhibit Number	Exhibit Description
3.1(1)	Amended and Restated Certificate of Incorporation.
3.2(2)	Amended and Restated Bylaws.

31.1* Certification of Periodic Report by Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

31.2* Certification of Periodic Report by Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**	Certification of Principal Executive Officer Pursuant to Rule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Title 18, United States Code).
32.2**	Certification of Principal Financial Officer Pursuant to Rule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Title 18, United States Code).

101.INS+	XBRL Instance Document
101.SCH+	XBRL Taxonomy Extension Schema Document
101.CAL+	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF+	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB+	XBRL Taxonomy Extension Label Linkbase Document
101.PRE+	XBRL Taxonomy Extension Presentation Linkbase Document

* Filed herewith.

**	Furnished herewith.
+	The financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission.

(1)	Previously filed as an exhibit to the Current Report on Form 8-K filed by us on April 11, 2017.
(2)	Previously filed as an exhibit to the Current Report on Form 8-K filed by us on April 11, 2017.

19

EX-31.1

 

Exhibit 31.1

Certification of Principal Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Peter Altman, certify that:

1.       I have reviewed this Quarterly Report on Form 10-Q of BioCardia, Inc.;

2.       Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.       Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.       The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)     Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)     Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)     Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.       The registrant's other certifying officer and I have disclosed to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)     All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)     Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: May 11, 2017

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

EX-31.2

Exhibit 31.2

Certification of Principal Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, David McClung, certify that:

1.       I have reviewed this Quarterly Report on Form 10-Q of BioCardia, Inc.;

2.       Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.       Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.       The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)     Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)     Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(c)     Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.       The registrant's other certifying officer and I have disclosed to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)     All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)     Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: May 11, 2017

/s/ David McClung

Name: David McClung

Title: Vice President of Finance

EX-32.1

Exhibit 32.1

Certification of Principal Executive Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Peter Altman, the President and Chief Executive Officer of BioCardia, Inc. (the "Company"), hereby certify, that, to my knowledge:

1.     The Quarterly Report on Form 10-Q for the period ended March 31, 2017 (the "Report") of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

1.     The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 11, 2017

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

EX-32.2

Exhibit 32.2

Certification of Principal Financial Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, David McClung, the Vice President of Finance of BioCardia, Inc. (the "Company"), hereby certify, that, to my knowledge:

1.     The Quarterly Report on Form 10-Q for the period ended March 31, 2017 (the "Report") of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2.     The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 11, 2017

/s/ David McClung

Name: David McClung

Title: Vice President of Finance

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Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2017	May 09, 2017
Document Information [Line Items]
Entity Registrant Name	BioCardia, Inc.
Entity Central Index Key	0000925741
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)		457,682,784
Document Type	10-Q
Document Period End Date	Mar. 31, 2017
Document Fiscal Year Focus	2017
Document Fiscal Period Focus	Q1
Amendment Flag	false

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Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Current assets:
Cash and cash equivalents	$ 19,032	$ 21,352
Accounts receivable, net of allowance for doubtful accounts of $1 and $2 at March 31, 2017 and December 31, 2016, respectively	121	74
Inventory	144	135
Prepaid expenses	252	356
Total current assets	19,549	21,917
Property and equipment, net	177	111
Other assets	54	54
Total assets	19,780	22,082
Current liabilities:
Accounts payable	291	525
Accrued liabilities	720	544
Deferred revenue	72	71
Grant liability	285	304
Total current liabilities	1,368	1,444
Deferred rent	62	56
Total liabilities	1,430	1,500
Stockholders’ equity:
Preferred stock, $0.001 par value, 50,000,000 shares authorized, no shares issued and outstanding at March 31, 2017 and December 31, 2016
Common stock, $0.001 par value, 750,000,000 shares authorized at March 31, 2017 and December 31, 2016, 457,682,784 shares and 457,575,631 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively	458	458
Additional paid-in capital	80,910	80,266
Accumulated deficit	(63,018)	(60,142)
Total stockholders’ equity	18,350	20,582
Total liabilities and stockholders’ equity	$ 19,780	$ 22,082

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Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Mar. 31, 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

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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Revenue:
Net product revenue	$ 109,000	$ 168,000
Collaboration agreement revenue	28,000	10,000
Total revenue	137,000	178,000
Costs and expenses:
Cost of goods sold	175,000	226,000
Research and development	1,033,000	441,000
Selling, general and administrative	1,804,000	587,000
Total costs and expenses	3,012,000	1,254,000
Operating loss	(2,875,000)	(1,076,000)
Other income (expense):
Interest expense, net	0	(550,000)
Change in fair value of convertible preferred stock warrant liability		53,000
Change in fair value of maturity date preferred stock warrant liability		(1,000)
Change in fair value of convertible shareholder notes derivative liability		78,000
Other expense	(1,000)
Total other expense, net	(1,000)	(420,000)
Net loss	$ (2,876,000)	$ (1,496,000)
Net loss per share, basic and diluted (in dollars per share)	$ (0.01)	$ (0.08)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	457,654,570	18,947,536

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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Operating activities:
Net loss	$ (2,876)	$ (1,496)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	13	10
Change in fair value of convertible preferred stock warrant liability		(53)
Change in fair value of maturity date preferred stock warrant liability		1
Change in fair value of convertible shareholder notes derivative liability		(78)
Share-based compensation	622	30
Non-cash interest expense on convertible shareholder notes		550
Changes in operating assets and liabilities:
Accounts receivable	(47)	(4)
Inventory	(9)	42
Prepaid expenses	104	28
Accounts payable	(249)	103
Accrued liabilities excluding accrued interest on convertible note	176	86
Deferred revenue	1	40
Deferred rent	6	(7)
Grant liability	(19)
Net cash used in operating activities	(2,278)	(748)
Investing activities:
Purchase of property and equipment	(64)
Net cash used in investing activities	(64)
Financing activities:
Proceeds from the exercise of stock options	22
Net cash provided by financing activities	22
Net decrease in cash and cash equivalents	(2,320)	(748)
Cash and cash equivalents at beginning of period	21,352	3,557
Cash and cash equivalents at end of period	19,032	2,809
Supplemental disclosures for noncash investing activity:
Accounts payable recognized for the purchase of equipment	$ 15

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Note 1 - Summary of Business and Basis of Presentation

3 Months Ended

Mar. 31, 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

therapeutic candidate is the CardiALLO cell therapy system. To date the Company has devoted substantially all of its resources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting its intellectual property.

The Company has

three

enabling device product lines:

(1)

the CardiAMP cell processing system;

(2)

the Helix biotherapeutic delivery system, or Helix; and

(3)

the Morph vascular access product line, or Morph, which offers advanced catheter products for interventional medicine.

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

(b) Reverse Merger

On

August

22,

2016,

the Company, its wholly-owned subsidiary, Icicle Acquisition Corp, and BioCardia Lifesciences, Inc., or BioCardia Lifesciences (at the time named BioCardia, Inc.)

, entered into an Agreement and Plan of Merger, or the Merger Agreement. The transactions contemplated by the Merger Agreement closed on

October

24,

2016,

pursuant to which Icicle Acquisition Corp. merged with and into BioCardia Lifesciences, with BioCardia Lifesciences continuing as the surviving company, or the Merger. BioCardia Lifesciences was determined to be the accounting acquirer in the Merger based upon the terms of the Merger and other factors, including: (i) former BioCardia Lifesciences security holders owned approximately

54%

of the combined company (on a fully diluted basis) immediately following the closing of the Merger, (ii) former BioCardia Lifesciences directors hold the majority of the board seats in the combined company, and (iii) former BioCardia Lifesciences management holds all of the key positions in the management of the combined company. Following the completion of the Merger, the Company changed its name to BioCardia, Inc.

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

shares of Company common stock, or the Exchange Ratio. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the capital structure as a result of the Merger.

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Note 2 - Significant Accounting Policies

3 Months Ended

Mar. 31, 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

March

31,

2017

and for the

three

months ended

March

31,

2017

and

2016

are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of

March

31,

2017,

results of operations and cash flows for the

three

months ended

March

31,

2017

and

2016.

The results for the

three

months ended

March

31,

2017

are not necessarily indicative of the results to be expected for the year ending

December

31,

2017

or for any other interim period or for any other future year.

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

-K for the year ended

December

31,

2016,

filed with the SEC on

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

$63.0

million as of

March

31,

2017.

Management expects operating losses and negative cash flows to continue through at least the next several years.

Upon closing of the Merger Agreement, the combined company had approximately

$24.0

million in cash, including

$19.0

million of cash acquired as part of the Merger and

$4.4

million in net proceeds from the issuance of convertible notes in

October

2016.

Management believes cash of

$19.0

million as of

March

31,

2017

is sufficient to fund the Company for at least the next

twelve

-month period following the date of issuance of these financial statements. The Company also plans to raise other additional capital, potentially including debt and equity arrangements, to finance its future operations. If adequate funds are not available, the Company

may

be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that

may

require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations. While the Company believes in the viability of its strategy to raise additional funds, there can be no assurances to that effect.

(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

of the notes to the financial statements included in the

2016

Form

10

-K. There have been no changes to those policies except as described below.

(f) Recently Adopted Accounting Pronouncement

In

March

2016,

the FASB issued ASU

2016

-

09,

Compensation - Stock Compensation (Topic

718):

Improvements to Employee Share-Based Payment Accounting (ASU

2016

-

09).

The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification in the statement of cash flows and forfeitures. The Company adopted ASU

2016

-

09

effective

January

1,

2017.

The impact of adopting ASU

2016

-

09

resulted in the following:

● We will classify 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 material impact to our condensed consolidated financial statements due to a full valuation allowance recognized against our deferred tax assets.

● 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 result in changes in our condensed consolidated statements of cash flow.

There were no other material impacts to our condensed consolidated financial statements as a result of adopting this updated standard.

(g) Recently Issued Accounting Pronouncements

In

May

2014,

the FASB issued ASU No.

2014

-

09,

Revenue from Contracts with Customers (Topic

606),

which provides comprehensive guidance for revenue recognition. ASU

2014

-

09

affects any entity which either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. The core principle of the guidance provides that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The new standard can be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of the change recognized at the date of the initial application in retained earnings.

In

August

2015,

the FASB issued ASU

2015

-

14

Revenue from Contracts with Customers, which deferred the effective date for implementation of the standard. Public entities are to apply the new standard for annual and interim reporting periods beginning after

December

15,

2017

and earlier application is permitted only as of annual reporting periods beginning after

December

15,

2016,

including interim reporting periods within that reporting period. The Company has not elected early adoption and has not concluded on an adoption method. The Company has formed a task force that is beginning to assess the Company’s customer contracts and the potential impacts the standard

may

have on previously reported revenues and future revenues.

 Given the relatively small volume of revenue arrangements, the Company believes that the analysis will be completed in sufficient time to adopt the new standard when required.

In

February

2016,

the FASB issued ASU

2016

-

02

Leases (Topic

842),

which supersedes existing guidance on accounting for leases in “Leases (Topic

840)”

and generally requires all leases to be recognized in the consolidated balance sheet. ASU

2016

-

02

is effective for annual and interim reporting periods beginning after

December

15,

2018;

early adoption is permitted. The Company does not plan to elect early adoption. The provisions of ASU

2016

-

02

are to be applied using a modified retrospective approach. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on the Company’s financial statement presentation or disclosures.

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Note 3 - Fair Value Measurement

3 Months Ended

Mar. 31, 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

– quoted prices in active markets for identical assets and liabilities

Level 

2

– observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities

Level 

3

– unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table sets forth the fair value of our financial assets measured on a recurring basis as of

March

31,

2017

and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	19,032	$	—	$	—	$	19,032

The following table sets forth the fair value of our financial assets measured on a recurring basis as of

December

31,

2016

and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	21,352	$	—	$	—	$	21,352

As discussed in Note

7,

in

2015,

the Company issued warrants to purchase preferred stock in connection with the note agreements to various shareholders as described below. The warrant liabilities were recorded at the fair value on the date of issuance and were remeasured each subsequent balance sheet date and as of the warrant exercise date, with fair value changes recognized as income (decrease in fair value) or expense (increase in fair value) in other income (expense) in the consolidated statements of operations.

  No warrants are outstanding as of

March

31,

2017.

In

May

2015,

the Company entered into note agreements with various stockholders of the Company and other lenders for a total of

$7.2

million, or the

2015

Notes. As discussed more fully in Note

7,

the

2015

Notes include embedded derivative features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The Company estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model from inception through

June

30,

2016.

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

Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Upon the completion of the Merger, the valuation of the compound embedded derivative was determined based on the settlement value of the common stock exchanged for the notes on

October

24,

2016.

  No notes are outstanding as of

March

31,

2017.

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Note 4 - Inventories

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Inventory Disclosure [Text Block]

(4 ) 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):

	March 31, 2017		December 31, 2016
Raw materials	$	53	$	59
Work in process		48		—
Finished goods		43		76
Total	$	144	$	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

result in recording additional write downs for excess or expired inventory in the future. Charges to cost of goods sold for inventory write-downs, scrap, shrinkage and expired inventories totaled approximately

$9,000

and

$18

,000

for the

three

months ended

March

31,

2017

and

2016,

respectively.

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Note 5 - Property and Equipment, Net

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Property, Plant and Equipment Disclosure [Text Block]

(5 ) Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):

	March 31, 2017			December 31, 2016
Computer equipment and software	$	172		$	143
Laboratory and manufacturing equipment		415			366
Furniture and fixtures		48			48
Leasehold improvements		326			325
Property and equipment, gross		961			882
Less accumulated depreciation		(784	)		(771	)
Property and equipment, net	$	177		$	111

Depreciation expense totaled approximately

$13,000

and

$10,000

for the

three

months ended

March

31,

2017

and

2016,

respectively.

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Note 6 - Accrued Liabilities

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

(6 ) Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

	March 31, 2017		December 31, 2016
Accrued expenses	$	572	$	478
Accrued clinical trial costs		86		—
Customer deposits		62		66
Total	$	720	$	544

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Note 7 - Convertible Notes

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Debt Disclosure [Text Block]

(7 ) Convertible Notes

In

May

2015,

 BioCardia Lifesciences entered into note agreements with various stockholders of BioCardia Lifesciences and other lenders for a total of

$7.2

million, or the

2015

Notes. The

2015

Notes accrued

8%

annual simple interest, matured

18

months from the issue date and were callable after the maturity date by written demand of a majority of the holders of the outstanding note principle. If BioCardia Lifesciences closed an effective registration statement filed under the Securities Act of

1933,

as amended, covering the sale of BioCardia Lifesciences common stock (an IPO) prior to maturity, the outstanding principle and accrued interest would have automatically converted into shares of common stock at

80%

of the price of the shares of common stock purchased in the IPO. If at any time prior to the maturity date, the Company closed a private placement of the Company’s preferred stock for aggregate sales proceeds of at least

$5.0

million excluding note conversions, at the note holder’s option, or the Optional Conversion Right, the outstanding principle and interest

may

 have been converted into shares of the preferred stock at a conversion price equal to

80%

of the price of the preferred shares sold in such financing, plus preferred stock warrant coverage equal to

8%

with an exercise price equal to the purchase price of the preferred stock sold in such financing. If the notes were held to maturity, subject to BioCardia Lifesciences authorizing sufficient shares of a new class of preferred stock, or the Maturity Date Preferred Stock, the holder would have had the option to convert the outstanding principle and interest to this new class of Maturity Date Preferred Stock at an exercise price of

$0.07

per share, plus

8%

warrant coverage.

In

August

2016,

the Company and the holders of the

2015

Notes amended the

2015

Notes, pursuant to which the outstanding principal amount and all accrued interest through

August

31,

2016

automatically converted into shares of BioCardia Lifesciences common stock at

80%

of the conversion price of the convertible notes issued in

October

2016.

In addition, the amendment eliminated the payment of interest for the period subsequent to

August

31,

2016,

and through the date of the closing of the Merger. Upon the completion of the Merger, the

2015

Notes and accrued interest converted into shares of BioCardia Lifesciences common stock, which were then exchanged at the Exchange Ratio into

67,443,988

shares of the Company’s common stock.

The

2015

Notes had redemption features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The changes in the estimated value are reflected in the change in fair value of convertible shareholder notes derivative liability in the consolidated statements of operations. 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

Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Immediately prior to the closing of the Merger, the compound embedded derivative was remeasured based on the settlement value of the common stock exchanged for the notes, and we reclassified the balance of the convertible shareholder notes derivative liability to additional paid-in capital.

The Company recognized interest expense, including amortization of the debt discount of approximately

$0

and

$550,000

for the

three

months ended

March

31,

2017

and

2016,

respectively. 

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Note 8 - Share-based Compensation

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Disclosure of Compensation Related Costs, Share-based Payments [Text Block]

(8 ) Share-Based Compensation

BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the

2002

Stock Plan in

2002,

or the

2002

Plan, and the Company assumed the

2002

Plan in the Merger. We will not grant any additional awards under the

2002

Plan following the Merger. In

2016,

BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the

2016

Equity Incentive Plan, or the

2016

Plan, and the Company assumed the

2016

Plan in the Merger. We will grant awards, including incentive stock options and nonstatutory stock options, under the

2016

Plan following the Merger.

Stock compensation attributable to manufacturing operations was not significant and was expensed directly to cost of goods sold in the condensed consolidated statements of operations. Share-based compensation expense for the

three

months ended

March

31,

2017

and

2016

was recorded as follows (in thousands):

	Three Months ended March 31,
	2017		2016
Cost of goods sold	$	41	$	1
Research and development		172		1
Selling, general and administrative		409		28
Share-based compensation expense	$	622	$	30

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		4,413,930			0.90
Stock options exercised		(107,153	)		0.20
Stock options cancelled		(407,382	)		0.04
Balance, March 31, 2017		45,803,123		$	0.22

The weighted average grant-date fair value of options granted during the

three

months ended

March

31,

2017

was

$0.72

per share.

Employee

Share-Based Compensation (Stock Options)

During the

three

months ended

March

31,

2017,

the Company granted stock options to certain non-employee directors and employees to purchase

2,466,147

shares of common stock. The fair value of each option grant is estimated on the date of the grant using the BSM option pricing model with the weighted average assumptions in the table below.  

Risk-free interest rate	2.05	–	2.07%
Volatility	88	–	89%
Dividend yield		None
Expected terms (in years)	6.00	–	6.25

Unrecognized share-based compensation for employee options granted through

March

31,

2017

is approximately

$4.1

million to be recognized over a remaining weighted average service period of

3.4

 years.

Employee

Share-Based Compensation (RSUs)

During the

three

months ended

March

31,

2017,

the Company granted to certain non-employee directors

736,000

restricted stock units, or RSUs. The fair value of each RSU is estimated on the closing market price on the grant date.  

The following summarizes the activity of non-vested RSUs:

			Weighted
			average
			grant date
	Number of		fair value
	shares		per share
Non-vested units, December 31, 2016		—
RSUs granted		736,000	$	0.92
RSUs vested		—
RSUs forfeited		—
Non-vested units, March 31, 2017		736,000	$	0.92

Unrecognized share-based compensation for employee RSUs granted through

March

31,

2017

is approximately

$630,000

to be recognized over a remaining weighted average service period of

2.8

years.

Nonemployee Share-Based Compensation

During the

three

months ended

March

31,

2017,

the Company granted options to purchase

1,947,783

shares of common stock to consultants. These options were granted in exchange for consulting services to be rendered and vest over the term specified in the grant, which correlates to the period the services are rendered. The Company recorded approximately

$233,000

and

$1,000

for the

three

months ended

March

31,

2017

and

2016,

respectively, as nonemployee share-based compensation expense.

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

March

31,

2017:

Risk-free interest rate	2.37	–	2.40%
Volatility		89%
Dividend yield		None
Expected terms (in years)	9.4	–	9.8%

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Note 9 - Net Loss Per Share

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Earnings Per Share [Text Block]

(9) 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:

	March 31,
	2017		2016
Stock options to purchase common stock		45,803,123		12,595,578
Unvested restricted stock units		736,000		-
Total		46,539,123		12,595,578

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Note 10 - Income Taxes

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Income Tax Disclosure [Text Block]

(1

0

)     Income Taxes

During the

three

months ended

March

31,

2017

and

2016,

there was

no

income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statement of operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets.

As of

March

31,

2017,

the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The r

ealization of the Company’s

deferred tax assets depends primarily

on its ability to generate

future taxable income

which is uncertain. The Company does

not

believe that its deferred tax

assets are realizable on a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.

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Note 11 - Grant Funding

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Grant Funding [Text Block]

(1

1

)     Grant Funding

In

June

2016,

the Company entered into a grant agreement with Maryland Technology Development Corporation, or TEDCO. TEDCO was created by the Maryland State Legislature in

1998

to facilitate the transfer and commercialization of technology from Maryland’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 to exceed

$750,000

to be used solely to finance the costs to conduct the research project entitled “Heart Failure Trial” over a period of

three

years. 

In the

fourth

quarter of

2016,

the Company received approximately

$312,000

under the grant which will be accounted for as a reduction to research and development expenses as the related qualifying costs are incurred. Approximately

$27,000

of the qualifying costs had been incurred as of

March

31,

2017.

The remaining

$285,000

is recorded as grant liability on the condensed consolidated balance sheet at

March

31,

2017.

The amount is recorded as a liability as the amounts are refundable, should a default by the Company, as defined in the agreement, occur prior to incurring the qualifying costs.

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Note 12 - Related Party Transactions

3 Months Ended

Mar. 31, 2017

Notes to Financial Statements

Related Party Transactions Disclosure [Text Block]

(1

2

)     

Related Party Transactions

In

August

2016,

the Company granted an option to purchase

5,027,726

shares of common stock, with

4

-year vesting period and the exercise price of

$0.15

per share, to OPKO Health, Inc., or OPKO, as 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

March

31,

2017,

and the Company recorded

$122,000

as expense during the

three

months ended

March

31,

2017.

The term of the consulting agreement is

4

years and will be automatically renewed for successive

one

year periods. The chairman and chief executive officer of OPKO is a beneficial owner of more than

5%

of the outstanding shares of the Company’s common stock and OPKO itself is also a beneficial owner of more than

5%

of the outstanding shares of the Company’s common stock. 

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Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 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

March

31,

2017

and for the

three

months ended

March

31,

2017

and

2016

are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of

March

31,

2017,

results of operations and cash flows for the

three

months ended

March

31,

2017

and

2016.

The results for the

three

months ended

March

31,

2017

are not necessarily indicative of the results to be expected for the year ending

December

31,

2017

or for any other interim period or for any other future year.

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

-K for the year ended

December

31,

2016,

filed with the SEC on

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

$63.0

million as of

March

31,

2017.

Management expects operating losses and negative cash flows to continue through at least the next several years.

Upon closing of the Merger Agreement, the combined company had approximately

$24.0

million in cash, including

$19.0

million of cash acquired as part of the Merger and

$4.4

million in net proceeds from the issuance of convertible notes in

October

2016.

Management believes cash of

$19.0

million as of

March

31,

2017

is sufficient to fund the Company for at least the next

twelve

-month period following the date of issuance of these financial statements. The Company also plans to raise other additional capital, potentially including debt and equity arrangements, to finance its future operations. If adequate funds are not available, the Company

may

be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that

may

require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations. While the Company believes in the viability of its strategy to raise additional funds, there can be no assurances to that effect.

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.

New Accounting Pronouncements, Policy [Policy Text Block]

(e) Significant Accounting Policies

The Company’s significant accounting policies are described in Note

2

of the notes to the financial statements included in the

2016

Form

10

-K. There have been no changes to those policies except as described below.

(f) Recently Adopted Accounting Pronouncement

In

March

2016,

the FASB issued ASU

2016

-

09,

Compensation - Stock Compensation (Topic

718):

Improvements to Employee Share-Based Payment Accounting (ASU

2016

-

09).

The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification in the statement of cash flows and forfeitures. The Company adopted ASU

2016

-

09

effective

January

1,

2017.

The impact of adopting ASU

2016

-

09

resulted in the following:

● We will classify 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 material impact to our condensed consolidated financial statements due to a full valuation allowance recognized against our deferred tax assets.

● 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 result in changes in our condensed consolidated statements of cash flow.

There were no other material impacts to our condensed consolidated financial statements as a result of adopting this updated standard.

(g) Recently Issued Accounting Pronouncements

In

May

2014,

the FASB issued ASU No.

2014

-

09,

Revenue from Contracts with Customers (Topic

606),

which provides comprehensive guidance for revenue recognition. ASU

2014

-

09

affects any entity which either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. The core principle of the guidance provides that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The new standard can be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of the change recognized at the date of the initial application in retained earnings.

In

August

2015,

the FASB issued ASU

2015

-

14

Revenue from Contracts with Customers, which deferred the effective date for implementation of the standard. Public entities are to apply the new standard for annual and interim reporting periods beginning after

December

15,

2017

and earlier application is permitted only as of annual reporting periods beginning after

December

15,

2016,

including interim reporting periods within that reporting period. The Company has not elected early adoption and has not concluded on an adoption method. The Company has formed a task force that is beginning to assess the Company’s customer contracts and the potential impacts the standard

may

have on previously reported revenues and future revenues.

 Given the relatively small volume of revenue arrangements, the Company believes that the analysis will be completed in sufficient time to adopt the new standard when required.

In

February

2016,

the FASB issued ASU

2016

-

02

Leases (Topic

842),

which supersedes existing guidance on accounting for leases in “Leases (Topic

840)”

and generally requires all leases to be recognized in the consolidated balance sheet. ASU

2016

-

02

is effective for annual and interim reporting periods beginning after

December

15,

2018;

early adoption is permitted. The Company does not plan to elect early adoption. The provisions of ASU

2016

-

02

are to be applied using a modified retrospective approach. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on the Company’s financial statement presentation or disclosures.

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Note 3 - Fair Value Measurement (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	19,032	$	—	$	—	$	19,032

	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	21,352	$	—	$	—	$	21,352

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Note 4 - Inventories (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Schedule of Inventory, Current [Table Text Block]

	March 31, 2017		December 31, 2016
Raw materials	$	53	$	59
Work in process		48		—
Finished goods		43		76
Total	$	144	$	135

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Note 5 - Property and Equipment, Net (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Property, Plant and Equipment [Table Text Block]

	March 31, 2017			December 31, 2016
Computer equipment and software	$	172		$	143
Laboratory and manufacturing equipment		415			366
Furniture and fixtures		48			48
Leasehold improvements		326			325
Property and equipment, gross		961			882
Less accumulated depreciation		(784	)		(771	)
Property and equipment, net	$	177		$	111

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Note 6 - Accrued Liabilities (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Schedule of Accrued Liabilities [Table Text Block]

	March 31, 2017		December 31, 2016
Accrued expenses	$	572	$	478
Accrued clinical trial costs		86		—
Customer deposits		62		66
Total	$	720	$	544

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Note 8 - Share-based Compensation (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Schedule of Share-based Compensation, Expense [Table Text Block]

	Three Months ended March 31,
	2017		2016
Cost of goods sold	$	41	$	1
Research and development		172		1
Selling, general and administrative		409		28
Share-based compensation expense	$	622	$	30

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		4,413,930			0.90
Stock options exercised		(107,153	)		0.20
Stock options cancelled		(407,382	)		0.04
Balance, March 31, 2017		45,803,123		$	0.22

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]

			Weighted
			average
			grant date
	Number of		fair value
	shares		per share
Non-vested units, December 31, 2016		—
RSUs granted		736,000	$	0.92
RSUs vested		—
RSUs forfeited		—
Non-vested units, March 31, 2017		736,000	$	0.92

Non-employee Stock Options [Member]

Notes Tables

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

Risk-free interest rate	2.37	–	2.40%
Volatility		89%
Dividend yield		None
Expected terms (in years)	9.4	–	9.8%

Employee Stock Option [Member]

Notes Tables

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

Risk-free interest rate	2.05	–	2.07%
Volatility	88	–	89%
Dividend yield		None
Expected terms (in years)	6.00	–	6.25

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Note 9 - Net Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2017

Notes Tables

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

	March 31,
	2017		2016
Stock options to purchase common stock		45,803,123		12,595,578
Unvested restricted stock units		736,000		-
Total		46,539,123		12,595,578

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Note 1 - Summary of Business and Basis of Presentation (Details Textual) - Merger [Member]	Oct. 24, 2016 shares
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

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Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016	Oct. 31, 2016	Oct. 24, 2016	Mar. 31, 2016	Dec. 31, 2015
Retained Earnings (Accumulated Deficit)	$ (63,018)	$ (60,142)
Cash and Cash Equivalents, at Carrying Value	$ 19,032	$ 21,352		$ 24,000	$ 2,809	$ 3,557
Proceeds from Convertible Notes [Member]
Cash and Cash Equivalents, at Carrying Value			$ 4,400
Tiger X [Member]
Cash and Cash Equivalents, at Carrying Value				$ 19,000

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Note 3 - Fair Value Measurement (Details Textual) - USD ($) $ in Thousands	Mar. 31, 2017	May 31, 2015
Notes Payable	$ 0
The 2015 Notes [Member]
Debt Instrument, Face Amount		$ 7,200

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Note 3 - Fair Value Measurement - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Assets:
Cash and cash equivalents	$ 19,032	$ 21,352
Fair Value, Inputs, Level 1 [Member]
Assets:
Cash and cash equivalents	19,032	21,352
Fair Value, Inputs, Level 2 [Member]
Assets:
Cash and cash equivalents
Fair Value, Inputs, Level 3 [Member]
Assets:
Cash and cash equivalents

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Note 4 - Inventories (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Inventory Write-down	$ 9,000	$ 18,000

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Note 4 - Inventories - Inventories (Details) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Raw materials	$ 53	$ 59
Work in process	48
Finished goods	43	76
Total	$ 144	$ 135

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Note 5 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Depreciation	$ 13,000	$ 10,000

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Note 5 - Property and Equipment, Net - Property and Equipment, Net (Details) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Property and equipment, gross	$ 961	$ 882
Less accumulated depreciation	(784)	(771)
Property and equipment, net	177	111
Computer Equipment and Software [Member]
Property and equipment, gross	172	143
Laboratory and Manufacturing Equipment [Member]
Property and equipment, gross	415	366
Furniture and Fixtures [Member]
Property and equipment, gross	48	48
Leasehold Improvements [Member]
Property and equipment, gross	$ 326	$ 325

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Note 6 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2017	Dec. 31, 2016
Accrued expenses	$ 572	$ 478
Accrued clinical trial costs	86
Customer deposits	62	66
Total	$ 720	$ 544

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Note 7 - Convertible Notes (Details Textual) - USD ($)		1 Months Ended	3 Months Ended
	Oct. 24, 2016	May 31, 2015	Mar. 31, 2017	Mar. 31, 2016	Aug. 31, 2016
Interest Expense			$ 0	$ 550,000
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

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Note 8 - Share-based Compensation (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value	$ 0.72
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross	4,413,930
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options	$ 4,100,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition	3 years 146 days
Share-based Compensation	$ 622,000	$ 30,000
Restricted Stock Units (RSUs) [Member]
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition	2 years 292 days
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period	736,000
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options	$ 630,000
Non-employee Directors and Employees [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross	2,466,147
Non-employee Directors [Member] | Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period	736,000
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	$ 233,000	$ 1,000

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Note 8 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Employee share-based compensation expense	$ 622	$ 30
Cost of Goods Sold [Member]
Employee share-based compensation expense	41	1
Research and Development Expense [Member]
Employee share-based compensation expense	172	1
Selling, General and Administrative Expenses [Member]
Employee share-based compensation expense	$ 409	$ 28

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Note 8 - Share-based Compensation - Stock Option Activity (Details)	3 Months Ended
	Mar. 31, 2017 $ / shares shares
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	4,413,930
Stock options granted (in dollars per share) | $ / shares	$ 0.90
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	45,803,123
Balance, weighted average exercise price, end of period (in dollars per share) | $ / shares	$ 0.22

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Note 8 - Share-based Compensation - Valuation Assumptions for Employee Stock Options (Details) - Employee Stock Option [Member]	3 Months Ended
	Mar. 31, 2017
Risk-free interest rate, minimum	2.05%
Risk-free interest rate, maximum	2.07%
Volatility, minimum	88.00%
Volatility, maximum	89.00%
Dividend yield	0.00%
Minimum [Member]
Expected terms (Year)	6 years
Maximum [Member]
Expected terms (Year)	6 years 91 days

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Note 8 - Share-based Compensation - Summary of Non-vested RSUs (Details) - Restricted Stock Units (RSUs) [Member]	3 Months Ended
	Mar. 31, 2017 $ / shares shares
Balance (in shares) | shares
Balance (in dollars per share) | $ / shares
RSUs granted (in shares) | shares	736,000
RSUs granted (in dollars per share) | $ / shares	$ 0.92
RSUs vested (in shares) | shares
RSUs vested (in dollars per share) | $ / shares
RSUs forfeited (in shares) | shares
RSUs forfeited (in dollars per share) | $ / shares
Balance (in shares) | shares	736,000
Balance (in dollars per share) | $ / shares	$ 0.92

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Note 8 - Share-based Compensation - Nonemployee Stock Option Valuation Assumptions (Details) - Non-employee Stock Options [Member]	3 Months Ended
	Mar. 31, 2017
Risk-free interest rate, minimum	2.37%
Risk-free interest rate, maximum	2.40%
Volatility	89.00%
Dividend yield	0.00%
Minimum [Member]
Expected terms (Year)	9 years 146 days
Maximum [Member]
Expected terms (Year)	9 years 292 days

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Note 9 - Net Loss Per Share - Antidilutive Securities (Details) - shares	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Antidilutive securities (in shares)	46,539,123	12,595,578
Employee Stock Option [Member]
Antidilutive securities (in shares)	45,803,123	12,595,578
Restricted Stock Units (RSUs) [Member]
Antidilutive securities (in shares)	736,000

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Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Income Tax Expense (Benefit)	$ 0	$ 0
Deferred Tax Liabilities, Net	$ 0

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Note 11 - Grant Funding (Details Textual) - USD ($)	1 Months Ended	3 Months Ended	10 Months Ended
	Jun. 30, 2016	Dec. 31, 2016	Mar. 31, 2017
Deferred Revenue from Grants, Current		$ 304,000	$ 285,000
Grant Agreement [Member] | TEDCO [Member]
Grant Funding Available	$ 750,000
Grant Funding, Term of Grant	3 years
Proceeds from Grant Funding		$ 312,000
Research and Development Expense Reduction from Qualified Grant Funding			27,000
Deferred Revenue from Grants, Current			$ 285,000

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Note 12 - Related Party Transactions (Details Textual) - USD ($)	1 Months Ended	3 Months Ended
	Aug. 31, 2016	Mar. 31, 2017	Mar. 31, 2016	Dec. 31, 2016	Oct. 24, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross		4,413,930
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price		$ 0.22		$ 0.15
Share-based Compensation		$ 622,000	$ 30,000
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 Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price	$ 0.15
Share-based Compensation		$ 122,000
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%