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, 2021

or

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

Commission file number: 001-38999

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 including zip code)

(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)

1

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 every Interactive Data File required to be submitted 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 such files).    Yes  ☒    No  ☐

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	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  ☒

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 Warrant to Purchase Common Stock	BCDA BCDAW	The Nasdaq Capital Market The Nasdaq Capital Market

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

There were 16,792,893 shares of the registrant’s Common Stock issued and outstanding as of May 1, 2021.

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Part I.	FINANCIAL INFORMATION	4
Item 1.	Unaudited Condensed Consolidated Financial Statements	4
	Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020	4
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020	5
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2021 and 2020	6
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4.	Controls and Procedures	22
Part II.	OTHER INFORMATION	23
Item 1.	Legal Proceedings	23
Item 1A.	Risk Factors	23
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3.	Defaults Upon Senior Securities	23
Item 4.	Mine Safety Disclosures	23
Item 5.	Other Information	23
Item 6.	Exhibits	24
EXHIBIT INDEX		24
SIGNATURES		25

FORWARD-LOOKING INFORMATION

This Quarterly Report on Form 10-Q, or 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 for the year ended December 31, 2020, 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 undertake no obligation to update any such forward-looking statement or reason why such results might differ after the date of this Quarterly Report on Form 10-Q, except as required by law.

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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)

(unaudited)

	March 31,			December 31,
	2021			2020
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	21,502		$	21,407
Accounts receivable, net of allowance for doubtful accounts of $16 at both March 31, 2021 and December 31, 2020		190			232
Prepaid expenses and other current assets		344			401
Other receivable due from related party		623			618
Total current assets		22,659			22,658
Property and equipment, net		164			145
Operating lease right-of-use asset, net		432			567
Other assets		53			54
Total assets	$	23,308		$	23,424
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	850		$	746
Accrued expenses and other current liabilities		2,248			2,205
Deferred revenue		1,180			683
Operating lease liability - current		468			614
Total liabilities		4,746			4,248
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020		—			—
Common stock, $0.001 par value, 100,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 16,792,893 and 16,297,381 shares issued and outstanding as of March 31, 2021 and December 31, 2020		17			16
Additional paid-in capital		137,588			135,234
Accumulated deficit		(119,043	)		(116,074	)
Total stockholders’ equity		18,562			19,176
Total liabilities and stockholders’ equity	$	23,308		$	23,424

See accompanying notes to condensed consolidated financial statements.

4

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

	Three months ended March 31,
	2021			2020
Revenue:
Net product revenue	$	—		$	5
Collaboration agreement revenue		46			33
Total revenue		46			38
Costs and expenses:
Cost of goods sold		—			4
Research and development		1,841			2,786
Selling, general and administrative		1,177			1,857
Total costs and expenses		3,018			4,647
Operating loss		(2,972	)		(4,609	)
Other income (expense):
Interest income		4			16
Other expense		(1	)		(1	)
Total other income (expense), net		3			15
Net loss	$	(2,969	)	$	(4,594	)
Net loss per share, basic and diluted	$	(0.18	)	$	(0.67	)
Weighted-average shares used in computing net loss per share, basic and diluted		16,569,268			6,831,976

See accompanying notes to condensed consolidated financial statements.

5

BIOCARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share amounts)

(unaudited)

	Common stock				Additional		Accumulated
	Shares		Cost		paid-in capital		deficit			Total
Balance at December 31, 2020		16,297,381	$	16	$	135,234	$	(116,074	)	$	19,176
Restricted stock units vested and issued		40,100		—		—		—			—
Sale of common stock		453,832		1		1,933		—			1,934
Exercise of common stock options		1,580		—		5		—			5
Share-based compensation		—		—		416		—			416
Net loss		—		—		—		(2,969	)		(2,969	)
Balance at March 31, 2021		16,792,893	$	17	$	137,588	$	(119,043	)	$	18,562
Balance at December 31, 2019		6,825,183	$	7	$	103,433	$	(101,070	)	$	2,370
Restricted stock units vested and issued		23,172		—		—		—			—
Share-based compensation		—		—		941		—			941
Net loss		—		—		—		(4,594	)		(4,594	)
Balance at March 31, 2020		6,848,355	$	7	$	104,374	$	(105,664	)	$	(1,283	)

See accompanying notes to condensed consolidated financial statements.

6

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited) 

	Three months ended March 31,
	2021			2020
Operating activities:
Net loss	$	(2,969	)	$	(4,594	)
Adjustments to reconcile net loss to net cash used in operating activities:
Write-off of inventory		—			3
Depreciation		14			22
Reduction in the carrying amount of right-of-use assets		135			118
Share-based compensation		416			941
Changes in operating assets and liabilities:
Accounts receivable		42			(32	)
Inventory		—			1
Prepaid expenses and other current assets		57			189
Other receivable due from related party		(5	)		—
Accounts payable		99			194
Accrued liabilities and other current liabilities		(23	)		293
Deferred revenue		497			(2	)
Operating lease liability - current		(146	)		20
Operating lease liability - noncurrent		—			(146	)
Net cash used in operating activities		(1,883	)		(2,993	)
Investing activities:
Purchase of property and equipment		(27	)		(5	)
Net cash used in investing activities		(27	)		(5	)
Financing activities:
Proceeds from sales of common stock		2,000			—
Proceeds from exercise of common stock options		5			—
Net cash provided by financing activities		2,005			—
Net change in cash and cash equivalents		95			(2,998	)
Cash and cash equivalents at beginning of period		21,407			5,585
Cash and cash equivalents at end of period	$	21,502		$	2,587
Supplemental disclosure for noncash investing and financing activities:
Unpaid issuance costs of common stock	$	66		$	—

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. (we, us, our, BioCardia or the Company), is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular and respiratory diseases with significant unmet medical needs. The Company’s lead therapeutic candidate is the CardiAMP® Cell Therapy System, which provides an autologous bone marrow derived cell therapy for treatment in two clinical indications: heart failure that develops after a heart attack and chronic myocardial ischemia. The Company’s second therapeutic platform is an investigational bone marrow derived allogeneic “off the shelf” Neurokinin-1 Receptor Positive mesenchymal stem cell therapy for the treatment of cardiac and pulmonary disease. To date, the Company has devoted substantially all 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.
	BioCardia also 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. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

(2) Significant Accounting Policies

(a)

Basis of Preparation

The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity, and cash flows as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 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 its financial position as of March 31, 2021, results of operations for the three months ended March 31, 2021 and 2020, and cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ended December 31, 2021 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, 2020, filed with the SEC on March 30, 2021.

(b)	Liquidity and Other Risks and Uncertainties
	Liquidity - The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $119.0 million as of March 31, 2021. Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as it advances its trials and development activities. Management believes cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund the Company’s planned expenditures and meet its obligations for at least 12 months following the filing of this form 10-Q.
(c)	Use of Estimates
	The preparation of the financial statements in accordance with U.S. GAAP requires 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 share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, inventory valuation, and assumptions used for revenue recognition.

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(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)	Changes to Significant Accounting Policies
	The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in its Annual Report on Form 10-K filed March 30, 2021 for the year ended December 31, 2020. There have been no changes to those policies.

(f)	Recent Accounting Pronouncements
	Recent accounting pronouncements issued by the Financial Accounting Standards Board (FASB), including its Emerging Issues Task Force 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 its financial assets measured on a recurring basis as of March 31, 2021 and December 31, 2020 and indicates the fair value hierarchy utilized to determine such fair value (in thousands):

	As of March 31, 2021
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,583	$	—	$	—	$	20,583
Cash in checking account		—		—		—		919
Total cash and cash equivalents	$	20,583	$	—	$	—	$	21,502

	As of December 31, 2020
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,662	$	—	$	—	$	20,662
Cash in checking account		—		—		—		745
Total cash and cash equivalents	$	20,662	$	—	$	—	$	21,407

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(4) Property and Equipment, Net

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

	March 31,			December 31,
	2021			2020
Computer equipment and software	$	166		$	159
Laboratory and manufacturing equipment		574			550
Furniture and fixtures		59			59
Leasehold improvements		332			332
Construction in progress		72			70
Property and equipment, gross		1,203			1,170
Less accumulated depreciation		(1,039	)		(1,025	)
Property and equipment, net	$	164		$	145

Depreciation expense totaled approximately $14,000 and $22,000 for the three months ended March 31, 2021 and 2020, respectively.

(5) Operating Lease Right-of-Use Asset, Net

The Company’s operating lease is a property lease for its laboratory and corporate offices. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants, nor does it contain an additional lease extension. The Company determines if an arrangement is a lease at inception by assessing whether it conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

Right-of-use (ROU) assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The Company’s lease does not provide an implicit rate. The Company used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. Variable rent expense is made up of expenses for common area maintenance and shared utilities and were not included in the determination of the present value of lease payments. The Company has no finance leases.

The lease expense for the three months ended March 31, 2021 and 2020 was $150,000. The cash paid under the operating lease during the three months ended March 31, 2021 and 2020 was $162,000 and $158,000, respectively. On March 31, 2021, the weighted average remaining lease term was 0.75 years, and the weighted average discount rate was 12.05%.

Future minimum lease payments under the operating lease as of March 31, 2021 are as follows (in thousands):

	Operating Lease March 31, 2021
Remainder of 2021	$	486
Total undiscounted lease payments		486
Less imputed interest		18
Total operating lease liabilities	$	468

10

(6) Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

	March 31,		December 31,
	2021		2020
Accrued expenses	$	240	$	87
Accrued salaries and employee benefits		851		961
Accrued clinical trial costs		457		452
Grant liability		610		615
Customer deposits		90		90
Total	$	2,248	$	2,205

(7) Stockholders’ Equity

Warrants - Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant.

	Number of		Weighted
	Common Stock		Average
	Warrants		Exercise Price
Balance, December 31, 2020		2,424,724	$	6.36
Warrants for common stock sold		—		—
Warrants for common stock exercised		—		—
Balance, March 31, 2021		2,424,724	$	6.36

Lincoln Park Capital stock purchase agreement - On March 29, 2021, the Company and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having an aggregate value of up to $20 million, subject to certain limitations and conditions set forth in the Purchase Agreement (the Offering). As consideration for entering into the Purchase Agreement, the Company agreed to issue to Lincoln Park 75,000 shares of common stock as commitment shares. In addition, the Company agreed to issue to Lincoln Park up to an aggregate of 50,000 additional shares of common stock as a further commitment fee based on a pro-rata percentage of the $20 million of common stock issued to Lincoln Park under the Purchase Agreement.

Pursuant to the Purchase Agreement, Lincoln Park purchased 373,832 shares of common stock, at a price of $5.35 per share, for a total gross purchase price of $2 million (the Initial Purchase) and the Company issued 80,000 shares of common stock as commitment shares, which included 5,000 commitment shares issued on a pro rata basis for the initial $2 million purchase. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2 million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase in multiple Accelerated Purchases on the same trading day or (ii) 30% of the total number of shares of the Company’s common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day.

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The Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement. In no event may the Company issue or sell to Lincoln Park under the Purchase Agreement shares of the Company’s common stock in excess of 3,266,177 shares (including the commitment shares), which represents 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of its common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the Purchase Agreement equals or exceeds $4.2736 per share. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 9.99% of its common stock.

The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at the Company’s sole discretion, except that during the 36 months after the date of the Purchase Agreement (subject to certain exceptions) the Company may not enter into any agreement to effect the issuance of its common stock or common stock equivalents in any “equity line of credit” or other similar continuous offering in which the Company may offer, issue or sell common stock or common stock equivalents at a future determined price, other than in connection with common stock issued pursuant to an “at-the-market offering” by the Company exclusively through a registered broker-dealer acting as agent of the Company pursuant to a written agreement between the Company and the registered broker-dealer. The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company.

As of March 31, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

(8) Share-Based Compensation

The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee’s respective function. No share-based compensation was capitalized during the periods presented. Share-based compensation expense for the three months ended March 31, 2021 and 2020 was recorded as follows (in thousands):

	Three Months ended March 31,
	2021		2020
Research and development	$	206	$	413
Selling, general and administrative		210		528
Total share-based compensation	$	416	$	941

On January 29, 2020 (the repricing date), the Company’s Board of Directors repriced certain previously granted and still outstanding vested and unvested stock option awards held by employees, executives and certain service providers of the Company; as a result, the exercise price was lowered to $5.32 per share. No other terms of the repriced stock options were modified, and the repriced stock options will continue to vest according to their original vesting schedules and will retain their original expiration dates. As a result of the repricing, 515,036 vested and unvested stock options outstanding with original exercise prices ranging from $10.05 to $97.21, were repriced.

The repricing on January 29, 2020 resulted in incremental stock-based compensation expense of $569,000, of which $412,000 related to vested employee stock option awards and was expensed on the repricing date, and $157,000 related to unvested stock option awards is being amortized on a straight-line basis over the approximately three year remaining weighted average vesting period of those awards.

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The following table summarizes the activity of stock options and related information:

	Options outstanding
	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrisinsic value (in thousands)
Balance, December 31, 2020		1,114,306		$	5.89		7.5	$	177.1
Stock options granted		18,850			4.63
Stock options exercised		(1,580	)		2.49
Stock options forfeited		(44,643	)		4.30
Stock options expired		(125	)		5.32
Balance, March 31, 2021		1,086,808		$	5.94		6.9	$	423.8
Exercisable, March 31, 2021		661,430		$	7.29		5.6	$	73.0

Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2021 is approximately $1.7 million to be recognized over a remaining weighted average service period of 2.2 years.

Share-Based Compensation (RSUs)

The following summarizes the activity of non-vested RSUs:

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2020		224,311		$	4.12
RSUs granted		18,792			4.34
RSUs released		(40,100	)		4.20
Balance, March 31, 2021		203,003		$	4.12

Unrecognized share-based compensation for employee and nonemployee RSUs granted through March 31, 2021 is approximately $24,000 to be recognized over a remaining weighted average service period of 2.1 years.

(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. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to its net loss position.

13

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,		December 31,
	2021		2020
Stock options to purchase common stock		1,086,808		1,114,306
Unvested restricted stock units		8,200		8,200
Common stock warrants		2,424,724		2,424,724
Total		3,519,732		3,547,230

(10) Income Taxes

During the three months ended March 31, 2021 and 2020, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets.

As of March 31, 2021, the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of its 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) Related Party Transactions

On April 9, 2020, the Company entered into a Litigation Funding Agreement (the Funding Agreement) with BSLF, L.L.C. (the Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding the Company’s legal proceedings and any and all claims, actions and/or proceedings relating to or arising from the case captioned Boston Scientific Corp., et al., v. BioCardia Inc., Case No. 3:19-05645-VC, U.S.D.C., N. D. Cal (the Litigation). BioCardia sought imposition of constructive trusts both on the patents naming Ms. Sarna as an inventor and the proceeds received from the sale of nVision to Boston Scientific, as well as damages, including unjust enrichment damages measured by the proceeds received from the sale of nVision to Boston Scientific.

Under the terms of the Funding Agreement, the Funder agreed to fund the legal fees and costs incurred by the Company in connection with the Litigation on and after March 1, 2020 on a non-recourse basis. The Company agreed to repay the Funder from any proceeds arising from the Litigation (the Litigation Proceeds), (i) any taxes paid by or imposed upon Funder (other than taxes imposed upon Funder as a consequence of Funder’s income) with respect to the claims, the litigation proceeds or as a consequence of any settlement in connection with the Litigation, if any, plus (ii) an amount, without reduction, set-off or counterclaim, equal to the amount actually paid by the Funder pursuant to the Funding Agreement (the Actual Funding Amount) plus (iii) the greater of:

(a) 50% of the remaining Litigation Proceeds, up to three times the Actual Funding Amount; or

(b) 30% of the remaining Litigation Proceeds.

Although the Company is required under the terms of the Funding Agreement to consult with the Funder regarding any settlement in connection with the Litigation and to allow Funder to participate in any real-time settlement negotiations, the Company has the sole and exclusive right to settle on whatever terms it deems acceptable. 

The Funding Agreement may be terminated by Funder upon ten days’ written notice to the Company. Funder is obligated to fund only the fees and costs incurred in the Litigation through the end of the month in which the termination notice was served. The Company may terminate the agreement upon ten days’ written notice to Funder from and after a failure by Funder to fulfill its obligations under the Funding Agreement if such failure or material breach is continuing at the end of such ten-day period. Under the terms of the agreement, the total due from the related party as of March 31, 2021 was approximately $623,000.

(12) Contingencies and Uncertainties

Contingencies - 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 is not aware of any current legal or administrative proceedings that are likely to have an adverse effect on the Company’s business, financial position, results of operations, or cash flows.

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Uncertainties - The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other interim period or for any other future year, particularly in light of the novel coronavirus pandemic, or COVID-19, and its impact on domestic and global economies. To limit the spread of COVID-19, governments have taken various actions including the issuance of stay-at-home orders and social distancing guidelines, causing some businesses to suspend operations and/or experience a reduction in demand for many products from direct or ultimate customers. Accordingly, businesses have adjusted, reduced or suspended operating activities and are continuing to adapt to these changing actions and guidelines.

Beginning March 17, 2020, substantially all of the Company’s workforce began working from home. On April 6, 2020, manufacturing operations resumed at the Company’s facilities, with a number of other staff continuing to work from home. While the direct effects of the stay-at-home orders and BioCardia’s work-from-home policies have been largely mitigated as of March 31, 2021, the overall impact of the pandemic resulted in disruption to the Company’s business and in delays in the Company’s development programs and regulatory and commercialization timelines. The overall magnitude of the continuing impact will depend, in part, on the length and severity of changing restrictions and other limitations on BioCardia’s ability to conduct the Company’s business. BioCardia’s future research and development expenses and general and administrative expenses may vary significantly if the Company experiences an increased impact from COVID-19 on the costs and timing associated with the conduct of BioCardia’s clinical trials and other related business activities. 

As the outbreak continues to mutate and spread, it may affect the Company’s operations and those of third parties on which the Company relies, including causing disruptions in the supply of the Company’s product candidates and the conduct of current and planned preclinical and clinical studies. BioCardia may need to limit operations and may experience limitations in employee resources. There are risks that the COVID-19 outbreak may be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly. The extent to which the coronavirus impacts the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

Additionally, while the potential economic impact brought by, and the duration of, a coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity, and the Company’s ability to complete its preclinical and clinical studies on a timely basis, or at all. The Company was successful in raising additional funding in 2020. However, the ultimate impact of coronavirus is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing, preclinical and clinical trial activities or the global economy as a whole. However, these effects could have a material, adverse impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which BioCardia relies.

(13) Subsequent Events

On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement. All claims in the Litigation have been dismissed. The settlement did not result in any material benefit or liability to the Company. The Company expects to terminate the Funding Agreement once all remaining matters thereunder are concluded.

On April 26, 2021, the Company issued a press release announcing that it has entered into an agreement with a leading Japanese biotechnology company related to the Company’s Helix catheter biotherapeutic delivery product candidates. This is the second new biotherapeutic delivery partnership for the Company in 2021. Under the terms of the agreement, the Company will receive $500,000, a portion of which is creditable for biotherapeutic delivery products and support services. The agreement has a one-year term with an option for the Japanese biotechnology company to negotiate a non-exclusive worldwide license for therapeutic delivery of certain cell types for cardiac indications.

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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 within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any and all statements contained in this Annual Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Quarterly Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems and our clinical trials, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) our ability to raise additional capital, (iv) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the SEC and (vi) the assumptions underlying or relating to any statement described in points (i) – (iv) above. 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 identified below and elsewhere in this Quarterly Report on Form 10-Q, those listed in our Annual Report on Form 10-K for the year ended December 31, 2020. Historical results are not necessarily indicative of future results. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.    

Overview

We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular and pulmonary diseases with large unmet medical needs. 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 and pulmonary conditions. Our CardiAMP cell therapy platform provides an autologous bone marrow derived cell therapy (using a patient’s own cells) for the treatment of two clinical indications: heart failure that develops after a heart attack (BCDA-01) and chronic myocardial ischemia (BCDA-02). Our allogeneic mesenchymal stem cell therapy platform, derived from donor cells and intended to be provided “off the shelf,” is also being advanced for two indications, heart failure (BCDA-03) and for the pulmonary indication of acute respiratory distress that has developed from COVID-19 (BCDA-04).

Our Helix™ Biotherapeutic Delivery System platform, or Helix, delivers therapeutics into the heart muscle with a helical needle from within the heart. It enables local delivery of cell, gene and protein-based therapies, including our own cell therapies to treat cardiac indications. The Helix system is CE marked in Europe and under investigational use in the United States. We selectively partner with firms developing other cell, gene and protein therapies utilizing the Helix and other biotherapeutic delivery systems that we have developed.  

Our AVANCE™ product offering for transseptal cardiac procedures has begun early commercialization activities in the United States through commission-only 1099 sales representatives. 

CardiAMP Cell Therapy for Heart Failure and Chronic Myocardial Ischemia

The Company’s lead platform, CardiAMP cell therapy, is an autologous cell therapy being advanced for two indications in pivotal clinical trials: heart failure and chronic myocardial ischemia.

The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at 40 centers nationwide, which includes a 10-patient roll-in cohort. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for heart failure which develops after a patient has a heart attack (BCDA-01). The trial is active at 24 clinical sites and 94 patients have been enrolled to date. The independent Data Safety Monitoring Board (DSMB) completed a prespecified data review on December 17, 2020, including all data for the 86 patients enrolled and 60 randomized patients that had reached their one-year follow-up at that date. The DSMB performed a risk-benefit review, indicated it had no safety concerns, and recommended in writing that the study continue as planned.  

The CardiAMP Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, controlled study of up to 343 patients at up to 40 clinical sites. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for the indication of chronic myocardial ischemia (BCDA-02). This therapeutic approach uses many of the same novel aspects as the CardiAMP Heart Failure Trial and is expected to leverage our experience and investment in the heart failure trial. The trial has been activated and we are working towards initial patient enrollment in the second quarter of 2021.  

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The Department of Health & Human Services Centers for Medicare & Medicaid Services, or CMS, has designated that both CardiAMP pivotal trials qualify for Medicare national coverage. Covered costs include patient screening, the CardiAMP Cell Therapy System and procedure, and clinical follow-up at one and two years after the procedure. Private insurance plans covering 50 million insured Americans follow this CMS reimbursement policy and are similarly anticipated to cover these costs. This coverage significantly reduces our cost of conducting these pivotal trials.   

ALLOGENEIC Cell Therapy for Cardiac and Pulmonary Disease

Our second therapeutic platform is our investigational culture expanded bone marrow derived allogeneic, Neurokinin-1 Receptor Positive mesenchymal stem cells (NK1R+ MSC). This “off the shelf” mesenchymal cell therapy is being advanced for cardiac and pulmonary disease. 

We are actively working to secure FDA acceptance of an Investigational New Drug (IND) application for a Phase I/II trial using the CardiALLO Cell Therapy System to deliver these allogeneic cells for the treatment of ischemic systolic heart failure (BCDA-03). We are working to receive FDA acceptance of the IND in 2021.

The Company also intends to submit an IND for the use of its allogeneic cell therapy for Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 (BCDA-04). Based on clinical reports on COVID-19, respiratory failure complicated by ARDS is a leading cause of death for COVID-19 patients. ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. BCDA-04 is on a similar timeline with BCDA-03 and we are working towards FDA acceptance of the IND in 2021.  

Financial Overview

Revenue

We currently have a portfolio of enabling and delivery products, from which we have generated modest revenue. Net product revenues include commercial sales of our Morph vascular access system in the US and EU and collaboration agreement revenues include revenue from partnering agreements with corporate and academic institutions. Under these partnering agreements, we provide our Helix biotherapeutic delivery system and customer training and support for use in preclinical and clinical studies.

Research and Development Expenses

Our research and development expenses consist primarily of:

• salaries and related overhead expenses, which include, but are not limited to 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 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 of 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 received. 

We plan to increase our research and development expenses for the foreseeable future as we continue the pivotal CardiAMP Heart Failure Trial, advance the pivotal CardiAMP Chronic Myocardial Ischemia Trial, and further develop our autologous and allogeneic cell therapy candidates. 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.

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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 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.

Other Income (Expense)

Other income and expense consist primarily of interest income we earn on our cash, cash equivalents and investments. 

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. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various judgements 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 clear from other sources. Actual results may differ from these estimates under different assumptions or conditions. 

The full extent to which the ongoing COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing, clinical trials and research and development will depend on future developments that continue to remain highly uncertain at this time. As events continue to evolve and additional information becomes available, our estimates may change materially in future periods.

We define our critical accounting policies as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations as well as the specific manner in which we apply those principles. Our critical accounting policies are described in Item 2 in our Annual Report on Form 10-K for the year ended December 31, 2020. 

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Results of Operations

Comparison of Three Months Ended March 31, 2021 and 2020

The following table summarizes our results of operations for the three months ended March 31, 2021 and 2020 (in thousands): 

	Three Months ended
	2021			2020
Revenue:
Net product revenue	$	—		$	5
Collaboration agreement revenue		46			33
Total revenue		46			38
Costs and expenses:
Cost of goods sold		—			4
Research and development		1,841			2,786
Selling, general and administrative		1,177			1,857
Total costs and expenses		3,018			4,647
Operating loss		(2,972	)		(4,609	)
Other income (expense):
Interest income		4			16
Other expense		(1	)		(1	)
Total other income (expense)		3			15
Net loss	$	(2,969	)	$	(4,594	)

Revenue.   Revenue increased to $46,000 in the first quarter of 2021 as compared to $38,000 in the first quarter of 2020. The amount and timing of collaboration revenues is largely dependent on our partners clinical activities and may be inconsistent and create significant quarter-to-quarter variation in our revenues. Collaboration revenue is expected to increase in 2021. Net product revenue in 2021 will be subject to customer demand, the availability of production resources for our new Morph product family members, and the timing of FDA clearance for market release of different models and sizes during the year. Net product revenue is also expected to increase in 2021.

Research and Development Expenses.  Research and development expenses decreased by approximately $945,000 to $1,841,000 during the first quarter of 2021 compared to the first quarter of 2020, primarily due to lower compensation expense following a repricing of stock options in the first quarter of 2020, and reduced clinical service provider costs and clinical site expenses in conducting the CardiAMP Heart Failure Trial. We expect research and development expenses for the year 2021 to increase moderately compared to 2020, as the lower compensation expenses discussed above are partially offset by increasing expenses associated with our clinical trials, obtaining regulatory approvals for our therapies, and improving our cell processing, manufacturing capabilities and delivery platforms.  

Selling, General and Administrative Expenses.  Selling, general and administrative expenses for the first quarter of 2021 decreased by approximately $680,000 to $1,177,000 compared to the first quarter of 2020, primarily due to lower compensation expense following a repricing of stock options in the first quarter of 2020, coupled with reduced professional service fees. We expect selling, general and administrative expenses to decrease modestly in 2021 relative to 2020.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of March 31, 2021, we had an accumulated deficit of approximately $119.0 million. We anticipate that we will continue to incur net losses for the next several years.

We have funded our operations principally through the sales of equity and convertible debt securities. As of March 31, 2021, we had cash and cash equivalents of approximately $21.5 million. 

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

	Three Months ended March 31,
	2021			2020
Net cash provided by (used in):
Operating activities	$	(1,883	)	$	(2,993	)
Investing activities		(27	)		(5	)
Financing activities		2,005			—
Net increase (decrease) in cash and cash equivalents	$	95		$	(2,998	)

Cash Flows from Operating Activities. The decrease in overall spending for operating activities of approximately $1.1million through the first quarter of 2021 compared to the first quarter of 2020 related primarily to the timing of advance payments from collaboration partners coupled with decreases in payments to third parties for professional fees. We expect net cash used in operating activities to remain relatively consistent in 2021 compared to 2020.

Cash Flows from Investing Activities. Net cash used in investing activities of $27,000 and $5,000 during the first quarter of 2021 and 2020, respectively consists of purchases of property and equipment, primarily lab and office equipment.

Cash Flows from Financing Activities. Net cash provided by financing activities of $2.0 million during the first quarter of 2021 consisted of gross proceeds from the sale of common stock in March 2021 less issuance costs. 

Lincoln Park Capital Stock Purchase Agreement

In March 2021, we and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of up to $20 million, subject to certain limitations and conditions set forth in the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, at the time we signed the Purchase Agreement, we sold 373,832 shares of our common stock at a price of $5.35 per share pursuant to the Purchase Agreement for gross proceeds of $2 million (and issued 80,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock, which consisted of 75,000 shares for Lincoln Park’s initial commitment and 5,000 shares issued on a pro rata basis in respect of Lincoln Park’s initial purchase of 373,832 shares). Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement, we have the right, from time to time, at our sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing sale price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2 million, unless we and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If we direct Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, we may direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase or (ii) 30% of the total number of shares of our common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, we may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day. As of March 31, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

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 autologous and allogeneic cell therapy 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.     

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Based upon our current operating plan, we believe that the cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund our operations for at least the next 12 months from the date of this filing. 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 clinical trials and related development programs;

• FDA acceptance of our autologous and allogeneic therapies for heart failure and other 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;

• 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 stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. 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 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.

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.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in our market risks during the three months ended March 31, 2021.

Our exposure to market risk is currently limited to our cash and cash equivalents, all of which have maturities of less than three months. The goals of our investment policy are preservation of capital, maintenance of liquidity needs, and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk or departing from our investment policy. We currently do not hedge interest rate exposure. Because of the short-term nature of our cash equivalents, we do not believe that an increase in market rates would have a material negative impact on the value of our portfolio.

Interest Rate Risk

As of March 31, 2021, based on current interest rates and total borrowings outstanding, a hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on our results of operations.

Foreign Currency Exchange Risks

We are a U.S. entity and our functional currency is the U.S. dollar. The vast majority of our revenues were derived from sales in the United States. We have business transactions in foreign currencies; however, we believe we do not have significant exposure to risk from changes in foreign currency exchange rates at this time. We do not currently engage in hedging or similar transactions to reduce our foreign currency risks. We will continue to monitor and evaluate our internal processes relating to foreign currency exchange, including the potential use of hedging strategies.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

In connection with the preparation of this Quarterly Report on Form 10-Q, as of March 31, 2021, an evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, 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). Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of March 31, 2021, our disclosure controls and procedures were, in design and operation, effective at a reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes to our internal control over financial reporting identified in connection with the evaluation required by rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended March 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

As previously reported, BioCardia and its wholly-owned subsidiary BioCardia Lifesciences, Inc. were party to several related legal proceedings (the Litigation) in Federal Court in San Francisco. The various counterparties were Boston Scientific Corporation, Boston Scientific Scimed Inc., Fortis Advisors LLC, Ms. Surbhi Sarna and nVision Medical Corporation. All parties to the Litigation entered into a confidential settlement agreement on March 12, 2021. All claims in the Litigation were then dismissed. The settlement did not result in any material benefit or liability to the BioCardia and BioCardia Lifesciences, Inc.  

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, 2020, which could materially affect our business, financial condition, or future results. The risks described in this report, our Annual Report on Form 10-K for the year ended December 31, 2020, and our Quarterly Reports on Form 10-Q filed periodically with the SEC 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

As reported in our Current Report on Form 8-K filed with the SEC on March 31, 2021, we announced that we expect to hold our 2021 Annual Meeting of Stockholders (the “2021 Annual Meeting”) on June 15, 2021. As the expected date of the 2021 Annual Meeting is more than 30 days before the anniversary of the Company’s 2020 Annual Meeting of Stockholders, we informed our stockholders of the change and the resulting changes to deadlines for proposals. No such proposals were received by such deadlines and we filed our proxy statement for the 2021 Annual Meeting on April 30, 2021.

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ITEM 6. EXHIBIT INDEX

Exhibit Number  Exhibit Description

3.1(1)	Amended and Restated Certificate of Incorporation, as amended May 6, 2019
3.2(2)	Amended and Restated Bylaws
10.1(3)	Purchase Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC
10.2(4)	Registration Rights Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC
10.3*	Consulting Agreement dated February 15, 2021, by and between BioCardia, Inc. and Henricus Duckers, M.D., Ph.D., FESC.
31.1*	Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*	Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**	Certification of Principal Financial Officer Pursuant to Rule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002.

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 Exhibit 3.1 to the Form 10-Q for the quarterly period ended June 30, 2019 filed by us on August 14, 2019.
(2)	Previously filed as Exhibit 3.2 to the Current Report on Form 8-K filed by us on April 11, 2017.
(3)	Previously filed as Exhibit 10.1 to the Current Report on Form 8-K filed by us on March 29, 2021.
(4)	Previously filed as Exhibit 10.2 to the Current Report on Form 8-K filed by us on March 29, 2021.

24

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 13, 2021	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)
Date:                        May 13, 2021	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

25

EX-10.3

Exhibit 10.3

EXECUTIVE STEERING COMMITTEE ADVISOR
CONSULTING AGREEMENT

This Consulting Agreement (the “Agreement”), effective as of February 15, 2021 (the “Effective Date”), is by and between

BioCardia, Inc., with offices located at 125 Shoreway Road, Suite B, San Carlos, California 94070 (“SPONSOR”)

and

Dr. Eric Duckers (“CONSULTANT”).

Background

WHEREAS, the SPONSOR is evaluating an investigational device called the CardiAMP System (“Study Device”) for use in patients with post myocardial infarction heart failure in a study in accordance with the Protocol entitled: “Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure,”, as may be amended from time to time, referred to as the CardiAMP Heart Failure Trial, which is incorporated herein by reference as part of this Agreement and the terms and conditions contained herein collectively (“Study”) on its behalf;

WHEREAS, SPONSOR, desires to Consultant to perform the Consulting Services (as defined below) as an advisor to the Executive Steering Committee (hereinafter “Steering Committee advisor”) in order to obtain the benefit and unique experience and ability of the Consultant in the Study and Consultant desires to perform such Consulting Services for the Study; and

Agreement

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, SPONSOR and Consultant, intending to be legally bound, agree as follows:

1. Definitions

Unless otherwise specifically provided in this Agreement, the following terms shall have the following meanings:

1.1 “Applicable Laws” shall mean all laws, ordinances, rules and regulations of any regulatory authority or any other state, local or federal governmental authority that apply to the conduct of the Study, the protection of the rights, safety and welfare of human subjects, the control of new devices under investigation, or the activities contemplated hereunder, including but not limited to: (i) the United States Federal Food, Drug and Cosmetic Act (“FDCA”); (ii) regulations and guidelines of the United States Food and Drug Administration (“FDA”), including but not limited to those set forth in the Unites States Code of Federal Regulation (“C.F.R.”); (iii) Good Clinical Practices, as set forth in 21 C.F.R. Parts 50 and 56 and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines; and (iv) all applicable privacy laws, rules and regulations (collectively “Privacy Laws”), including the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act of 1996 45 C.F.R. Parts 160 and 164, as amended and including its implementing regulations (collectively “HIPAA”); and (v) laws and regulations governing payments, remuneration, and referrals to and from healthcare providers, disclosure thereof, and export, including, but not limited to the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1, et seq.), the Stark Law (42 U.S.C. §§ 1395nn, et seq.), the Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b), et seq.), and the Patient Protection and Affordable Care Act (42 U.S.C. § 1320a-7h).

1.2 “Confidential Information” means all confidential, proprietary, or trade secret information, property or material of SPONSOR and any derivatives, portions or copies thereof, including, without limitation, information resulting from or in any way related to the Consulting Services provided, the business practices, plans or relationships of SPONSOR and any other information or material that SPONSOR designates as Confidential Information. Confidential Information includes, without limitation, all information received from or on behalf of Sponsor, or the Study sites or personnel involved in the Study, or created, generated or developed in connection with the Study, the Consulting Services hereunder, or using or incorporating other Confidential Information, including the terms of this Agreement, investigator’s brochure, Protocol, Manual of Operations, the identity and characteristics of the Study Devices (and all information relating thereto), Inventions (as defined below), Study records, reports, data, newsletters, safety reports and analysis, and any information about the subjects participating in the Study, including personal health information, and medical records and reports.

1.3 “Consulting Services” means the services set forth in Schedule 1, with such modifications to Schedule 1 as SPONSOR may reasonably request from time to time.

1.4 “Parties” means SPONSOR and Consultant and “Party” shall mean either of SPONSOR or Consultant.

1.5 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

1.5 “Term” means the period beginning on the Effective Date and continuing until completion of Consulting Services unless earlier terminated in accordance with Section 10 of the Agreement.

2 Scope of Consulting Services

SPONSOR hereby engages the Consultant, and the Consultant hereby agrees to provide the Consulting Services as set out in Schedule 1 to this Agreement. The Consultant shall furnish, at the Consultant’s own expense (subject to Section 3), any and all materials, equipment, services or supplies necessary or useful to successfully complete the Consulting Services. The Consultant shall use his or her best efforts to successfully complete the Consulting Services and shall perform such Consulting Services to the highest professional standards and in compliance with all Applicable Laws, the Study Protocol, and this Agreement. The Parties agree that completion of the Consulting Services within the agreed-upon time period is an essential term of this Agreement.

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3. Compensation and Out-of-Pocket Expenses

3.1 Payments

3.1.1 SPONSOR agrees to provide payments to the Consultant for Consulting Services as set forth in Schedule 2.

3.1.2 All payments shall be made for Consulting Services carried out in accordance with this Agreement and all Applicable Laws governing such Consulting Services.

3.1.3 The Consultant acknowledges that the amounts to be paid by SPONSOR under this Agreement represent reasonable, fair market value compensation for the work performed and the Consultant has received no other compensation or other inducement in connection with this Agreement or its participation in Consulting Services for the Study. Except with respect to those expenses set out in Schedule 2, Consultant acknowledges and agrees that the payments made by SPONSOR under this Agreement represent SPONSOR’s total financial obligations under this Agreement, and fully cover the cost of conducting the Consulting Services for the Study.

3.3 Compensation/Reconciliation Upon Early Termination

If the Study is discontinued for any reason it is agreed that the compensation paid or to be paid, shall be prorated based on actual work performed pursuant to this Agreement. Any funds not due under this calculation, but already paid, shall be returned to SPONSOR, less reasonable non-cancelable third party expenditures set forth in Schedule 2 and incurred by Consultant, subject to an obligation on the Consultant to mitigate any loss, for the purpose of conducting Consulting Services for the Study, within thirty (30) days of the termination date.

3.4 All Costs

3.4.1 Payment will be remitted to Consultant according to the compensation and payment terms set forth in Schedule 2.

3.4.2 The payments set forth in Schedule 2 represent all Consulting Services costs for the Study, and no other moneys shall be payable, unless otherwise approved by SPONSOR in writing. All amounts payable by SPONSOR under this Agreement are stated inclusive of any tax, which CONSULTANT may be obligated to pay.

3.4.3 The CONSULTANT shall provide SPONSOR with a completed and signed SPONSOR-specific Form W-9 prior to any payments being made under this Agreement. In the event of a conflict between the Payee and Tax Identification Number set forth in Schedule 3 and the SPONSOR-specific Form W-9, the SPONSOR-specific Form W-9 shall control.

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3.4 Budget Non-Disclosure

The Consultant shall consider all budget information as Confidential Information and will discuss such information exclusively with SPONSOR except where required by applicable law. Any other discussion of this Agreement or its budget terms with any third party may result in the discontinuation of the Consulting Services provided by Consultant, with no further obligation of SPONSOR to the Consultant.

3.6 Transparency

SPONSOR may disclose for any lawful purpose, within their sole discretion, the terms of this Agreement, including without limitation, the total compensation (including fees and expenses) payable or paid pursuant to this Agreement.  The parties acknowledge and agree that certain federal, state, and local laws, rules, and regulations (including, but not limited to the Patient Protection and Affordable Care Act (42 U.S.C. § 1320a-7h (amending Part A of Title XI of the Social Security Act by adding section 1128G) (2010)) may require disclosure of certain information relating to this Agreement, the relationship between the parties, and payments made hereunder. Consultant agrees that Sponsor is authorized to make such disclosures, to the fullest extent it deems necessary, to comply with such law, rule, and/or regulation. Consultant further agrees to cooperate with such disclosure by Sponsor.

4. Relationship of the Parties

The status of a Party under this Agreement shall be that of an independent contractor. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture, employment or agency relationship between the Parties or, except as otherwise expressly provided in this Agreement, as granting either Party the authority to bind or contract any obligation in the name of or on the account of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party.

Consultant agrees that neither this Agreement nor the Consulting Services performed hereunder will entitle Consultant to participate in or accrue or receive benefits under any employee benefits plans, group insurance plans or programs, or any other arrangement, program, or policy maintained by SPONSOR that provides employee benefits. The Consultant will be solely and unconditionally responsible for paying any and all taxes and assessments relating to any income or other consideration that the Consultant derives from this Agreement. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.

For the avoidance of doubt, the Consultant’s status in respect of the SPONSOR shall be that of an independent contractor.

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5. Intellectual Property

5.1 Ownership Any inventions, ideas, discoveries, processes, know-how, trade secrets, data, reports, conclusions, findings, original works, concepts, devices, new uses, improvements, modifications, patents and/or other intellectual property relating to the Study Device, Sponsor’s Confidential Information, or otherwise arising from or out of the Study or the Consulting Services, whether patentable or copyrightable or not, conceived, generated or first reduced to practice, as the case may be, during the term of this Agreement (hereinafter called “Inventions”), shall, without further remuneration for the Consultant, be the property of the SPONSOR. All Inventions and all original works of authorship relating to or arising out of the Study, the Consulting Services, the Study Device (including, but not limited to, any derivations, modifications, or alternative or new uses therefor), intellectual property, or Confidential Information, made or conceived by the Consultant during the term of this Agreement and for one (1) year thereafter shall be works made for hire and shall become and remain the sole and exclusive property of the Sponsor. To the extent that ownership of such Inventions and original works of authorship does not automatically vest in the Sponsor, the Consultant hereby transfers and assigns to the Sponsor all right, title and interest in and to the same, whether or not patent or copyright applications are filed thereon.

5.2 Disclosure The Consultant shall promptly disclose to SPONSOR and/or the SPONSOR, in writing, any Invention and/or works of authorship.

5.3 Cooperation The Consultant shall take all such actions throughout the term of this Agreement and thereafter as shall be necessary in order to ensure that the Inventions may be vested free of encumbrance in the SPONSOR in accordance with Section 5.1 above. The Consultant shall further cooperate with the SPONSOR, at the SPONSOR’s reasonable expense, by promptly executing any documents or carrying out any acts that may be required to vest the rights in or to Inventions in the SPONSOR and otherwise to enable the SPONSOR fully to protect its intellectual property.

5.4 Background Rights For the avoidance of doubt all intellectual property rights and rights of a similar nature owned by or licensed to a Party prior to the date of this Agreement shall remain that Party’s property.

6. Confidential Information

6.1 The Consultant agrees that he or she will have access to, or become acquainted with, Confidential Information of SPONSOR. Confidential Information may be disclosed to Consultant either orally, visually, in writing, by delivery of materials containing Confidential Information or in any other form or medium. The Consultant will keep Confidential Information in strict confidence, will use Confidential Information only in connection with the performance of the Consulting Services, and will not, during or after the Term, without SPONSOR’s prior written consent, disclose, disseminate or otherwise make available or allow access to Confidential Information to any third party. If the Consultant becomes aware of disclosure or misuse, he or she will immediately notify SPONSOR and take reasonable steps to prevent further disclosure or misuse, as requested by SPONSOR.

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6.2 The obligations of non-disclosure do not apply where the Consultant can prove by competent written evidence (a) the Confidential Information was known to the Consultant prior to the Effective Date and that was not subject to any confidentiality restrictions, (b) the Confidential Information was lawfully obtained from a third party without any confidentiality obligations, or (c) the Confidential Information is or becomes part of the public domain through no fault of the Consultant.

6.3 Notwithstanding Section 6.1, if the Consultant is requested to disclose Confidential Information by a lawful, judicial, or government order, the Consultant will immediately notify SPONSOR to permit SPONSOR to defend against any such order of disclosure, and Consultant will assist in such defense to the extent permitted by law.

6.4 The obligations of nondisclosure set forth in this section 6 will commence upon the Effective Date and shall survive and continue for ten (10) years after the expiration or earlier termination of this Agreement.

7. Subcontractors

7.1 The Consultant shall not engage or make use of subcontractors for the purpose of providing the Consulting Services or any other obligations under this Agreement except as expressly authorized by SPONSOR in writing. Any such permitted subcontract shall be subject to the applicable terms and conditions of this Agreement, and, upon SPONSOR’s request, the Consultant shall require any such subcontractor to enter into an agreement, pursuant to which the terms and conditions of this Agreement shall apply directly between such subcontractor and SPONSOR prior to disclosing to such subcontractor any Confidential Information, provided, however, that no such subcontract shall release the Consultant from any of its obligations under this Agreement except to the extent such obligations are satisfactorily performed by such subcontractor in accordance with this Agreement.

7.2 SPONSOR may subcontract with an independent third party Contract Research Organization (“CRO”), as shall be more specifically identified in writing by Sponsor. CRO may perform some of SPONSOR’s obligations under this Agreement on SPONSOR’s behalf, as may be more specifically set forth in writing by Sponsor, including but not limited to, invoicing and administering and making payments to Steering Committee advisors, facilitating, assisting in, and monitoring the performance of the Steering Committee advisors, providing, collecting, receiving, generating and storing information on SPONSOR’s behalf. Notwithstanding SPONSOR’s use of the CRO, all obligations of Consultant under this Agreement are owed to SPONSOR and any payments made under this Agreement, whether made by SPONSOR or CRO, shall be attributable to SPONSOR. SPONSOR may, in its sole discretion, replace, cease to use, or modify the duties of CRO at any time and in such event, will provide Consultant with written notice of such replacement, modification of duties or termination. In no event shall CRO have the authority to amend, modify, terminate, or waive any rights under this Agreement on behalf of SPONSOR or otherwise enter into a legally binding agreement on behalf of SPONSOR.

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8. Use of Name

Each Party shall not mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party in any publication, press release, promotional material or other form of publicity without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld). The restrictions imposed by this Section shall not prohibit either Party from making any disclosure identifying the other Party that is required by Applicable Law or the requirements of a regulatory body, provided that any such disclosure shall be governed by Section 6. Furthermore, the Consultant shall not mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of SPONSOR in any publication, press release, promotional material or other form of publicity without the prior written consent of SPONSOR in each instance (which shall not be unreasonably withheld).

9. Representations, Warranties and Covenants of Consultant

The Consultant represents and warrants to SPONSOR that:

(a) he/she has full power and authority, and has taken all necessary actions and has obtained all necessary authorizations, licenses, consents and approvals required, to execute and perform this Agreement;

(b) his/her retention as a consultant by SPONSOR and his/her performance of the Consulting Services do not, and will not, breach any agreement that obligates Consultant to keep in confidence any trade secrets or Confidential Information and refrain from competing, directly or indirectly, with the business of any other party;

(c) (i) neither he/she nor any of his/her personnel engaged in the Consulting Services has been debarred, is subject to debarment or has otherwise been disqualified or suspended from performing scientific or clinical investigation, or is the subject of an action or investigation that could lead to the debarment or disqualification of Consultant, or otherwise subjected to any restrictions or sanctions by the FDA or any other governmental or regulatory authority or professional body with respect to the performance of scientific or clinical investigations (a “Debarred Person”), (ii) the Consultant shall not use in any capacity, in connection with the Consulting Services, any Debarred Person, and (iii) in the event that Consultant or any of Consultant’s personnel become a Debarred Person, Consultant shall immediately notify SPONSOR and SPONSOR may immediately terminate this Agreement;

(d) if a governmental or regulatory authority conducts or gives notice of its intent to conduct an audit/inspection relating to services provided by the Consultant, the Consultant will give notice to SPONSOR of not less than three (3) business days and permit SPONSOR and/or the SPONSOR to be present at, and participate in, the inspection;

(e) he/she shall conduct the Consulting Services in accordance with all Applicable Laws, the Study Protocol, and this Agreement;

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(f) he/she has truthfully and accurately completed and certified the Certification of Financial Interests and Disclosure of Financial Interest statements contained in Schedules 4 and 5; and

(g) he/she has no financial, scientific or regulatory conflicts of interest in carrying out the Consulting Services under this Agreement or is not prohibited from entering this Agreement. During the course of this Agreement, the Consultant is required to disclose to SPONSOR and to such Steering Committee (SC) as may be appointed by the SPONSOR in accordance with Steering Committee Charter, any consulting agreements and/or any financial interests, he/she may have in the SPONSOR or any interests the Consultant is required to disclose under the SC Charter. The Consultant shall provide information about other concurrent Steering committee or endpoint adjudication committee membership or potential conflicts of interest where requested by SPONSOR and/or the SC.

10. Termination; Effect of Termination

10.1 Termination for Breach. Either party may terminate the Agreement by upon thirty (30) days prior written notice at any time for any reason.

10.2 Effect of Termination Upon termination of this Agreement by SPONSOR, the Consultant shall promptly cease performance of his or her obligations under this Agreement. The expiration or termination of this Agreement shall be without prejudice to any rights or obligations of the Parties that may have accrued prior to the termination and, except as otherwise expressly provided herein, shall not limit any rights or remedies which may be available by law or otherwise.

10.3.1 Upon the termination or expiration of this Agreement, the Consultant shall at SPONSOR’s option and direction, either destroy or return to SPONSOR all Confidential Information received from SPONSOR and, upon SPONSOR’s request, certify Consultant’s destruction or return of all such Confidential Information.

10.3.2 In the event of such termination, the Consultant will be entitled to receive (a) any compensation due and payable under Section 3 but not yet paid as of the effective date of termination, and (b) payment of reasonable and necessary out-of-pocket expenses reimbursable under Section 3 that are paid or incurred by the Consultant prior to the effective date of termination.

10.3.3 Any invoice, together with the other information required pursuant to Section 3, must be received no later than thirty (30) days after the effective date of termination. Such payments will constitute full and complete settlement of all claims of the Consultant against SPONSOR in connection with this Agreement.

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11. Assignment

The Consultant may not assign his or her rights and/or delegate his or her obligations under this Agreement without the prior written consent of SPONSOR, which consent shall not be unreasonably withheld. SPONSOR shall have the power to assign this Agreement to the its affiliates without the Consultant’s consent.

12. Governing Law and Jurisdiction

This Agreement, and all disputes and/or claims arising under this Agreement, shall be interpreted and governed by the laws of California, without regard to conflict of laws principles.

13. Notices

Any notice or other communication permitted or required under this Agreement shall be in writing and be deemed received only if hand delivered, sent by overnight delivery service or mailed by certified or registered mail to the following addresses:

If to SPONSOR

BioCardia, Inc.

125 Shoreway Road, Suite B

San Carlos, California 94070

Attention: Peter Altman

If to the Consultant

Dr. Eric Duckers

14. Survival

The respective rights and obligations of the parties in Sections 3.6, 5, 6, 7, 8, 9, 10, 12, 13, 15, and this Section 14 will survive the termination or expiration of this Agreement to the extent necessary to the intended preservation of such rights and obligations.

15. Entire Agreement and Amendment

This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement. Each Party confirms that it is not relying on any representations, warranties or covenants of the other Party except as specifically set out in this Agreement. Nothing in this Agreement is intended to limit or exclude any liability for fraud. All Schedules and Attachments referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement. No modification will be effective unless in writing and signed by authorized representatives of both Parties.         

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16. Anti- Bribery and Anti-Corruption

Consultant acknowledges that certain federal, state and local laws, rules and regulations (including, but not limited to, the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1, et seq.), the Stark (“Self-Referral”) Law (42 U.S.C. §§ 1395nn, et seq.), and the Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b), et seq.) ) may impose fines or penalties on Sponsor in the event Sponsor or others acting on its behalf make payments, remuneration, compensation, or referrals in contravention thereof. Consultant agrees that it shall not engage in any activities, directly or indirectly, in its performance under this Agreement that would cause it or Sponsor to be in violation of these or similar laws, rules, or regulations. Consultant further agrees, upon reasonable request of Sponsor, to give Sponsor reasonable written assurance and cooperation to assure Sponsor that Consultant has done nothing to cause liability to Sponsor under the above-mentioned laws, rules and regulations.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

SPONSOR:

   /s/ Peter A. Altman                                                           

Name: Peter A Altman

Title: CEO

Consultant:

  /s/ Henricus J. Duckers                                                   

Name: Dr. Eric Duckers

Title: Consultant

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Schedule 1

Consulting Services

Consulting Services to be provided for the duration of the Study shall include but not be limited to the following:

Steering Committee Advisor

● Attendance at meetings and/ or telephone conferences including but not limited to Steering Committee (SC) organizational, data review, and post-study meetings;

● Attendance at any other meetings that may be necessary from time to time;

● Assist as a advisor of the SC in reviewing final study results;

● Review all materials provided to the Consultant in advance of the above meetings. In relation to closed sessions of the SC meetings, the Consultant shall not retain, collect and/or copy any materials provided to the Consultant for the purpose of a closed session of the SC meeting.

● Assist as a advisor of the SC in issuing and making recommendations regarding any aspect of the conduct or design of the Study;

● Review study information and interim results;

● Review all minutes of meetings received;

● Liaise with SPONSOR Support Group where required, and

● Carry out all duties and tasks necessary to carry out the role as an advisor of the SC for the Study.

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Schedule 2

PAYMENT SCHEDULE AND PAYMENT TERMS

1.1 Steering Committee Consultant Fees. During the term of this Agreement, SPONSOR will pay the Contractor an hourly rate of $400 per hour for meeting attendance or preparation of meeting attendance.

a. Consultant will request payment by submitting an invoice to SPONSOR that identifies the date and nature of the Consulting Services rendered, the time spent by Consultant performing Services, and the total Consultant Fees earned.

b. Consultant will submit an invoice no later than 30 days after Consulting Services detailed in the invoice have been rendered.

c. SPONSOR will pay per Consultant Fees within 30 days after receipt of the invoice, unless there is a good faith dispute regarding any of the charges therein.

1.2 Pass-Through Expenses. SPONSOR will reimburse Consultant for reasonable and necessary travel expenses for travel required to perform Consulting Services and for certain other out-of-pocket expenses that have been prospectively approved, in writing, by SPONSOR (collectively, “Pass-Through Expenses”). It is agreed on that travel costs for intercontinental flights using “business class” and for flights within EU “economy class” will be reimbursed and that travel time will not be reimbursed.

a. Consultant will submit an invoice to SPONSOR within 30 days after incurring an authorized Pass-Through Expense. Consultant will include on the invoice a detailed accounting of the Pass-Through Expenses, accompanied by copies of the receipts.

b. SPONSOR will reimburse Pass-Through Expenses within 30 days after receipt of the invoice and accompanying receipts, unless there is a good faith dispute regarding any of the expenses therein.

1.3 Total Amount Payable. The total amount of Consulting Fees payable under this Agreement (exclusive of Pass-Through Expenses) shall not exceed $1,000 per month.

1.4 Final Invoices. Consultant will submit final invoices within 60 days after expiration or termination of this Agreement. Unless SPONSOR authorizes later submission, in writing, SPONSOR has no obligation to pay invoices received later than 90 days after expiration or termination of this Agreement.

1.5 Invoices should be sent to:

BioCardia, Inc.
125 Shoreway Rd Suite B
San Carlos, CA 94070

Attn: Accounts Payable

e-mail:

With a copies to:         

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Schedule 3

CERTIFICATION OF FINANCIAL INTEREST

Title of Clinical Study:	Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
Investigational Device:	The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter
Sponsor:	BioCardia, Inc.
	125 Shoreway Rd Suite B
	San Carlos, CA 94070
Consultant:
As a Steering Committee (SC) consultant for the Study, I certify that I, my spouse or dependent children (check the appropriate box for each statement):
[  ] Have [ X ] Do not have	Have an ownership interest, stock options, or other financial interest (i.e., equity interest) in the Sponsor (public or non-public) that owns the Investigational Device being evaluated in the Study.
[  ] Have [ X ] Do not have	Have property or other financial interest (i.e., proprietary interest) in the Investigational Device being evaluated in the Study; including, but not limited to, a patent or patent interest, trademark, copyright, licensing agreement, or any arrangement tied to a current or future right to receive royalties associated with the development or eventual commercialization of the Investigational Device.
[  ] Have [X  ] Do not have	Receive payments from the Sponsor that owns the respective Investigational Device during the term of the conduct of the Study; nor do I anticipate receiving payments from the Sponsor during a 1 year period following completion of the Study.   Applicable payments (i.e., financial interest) include, but are not limited to, grants to fund projects or research or compensation in the form of monetary payments, equipment, or retainers for consultation or honoraria.

If the response to any of the above statements is affirmative, completion of the Disclosure of Financial Interest is required.

Eric Duckers

Name of Consultant (Printed or Typed)

/s/ Henricus J. Duckers	2/15/2021
Signature of Consultant	Date

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Schedule 5

DISCLOSURE OF FINANCIAL INTEREST

Title of Clinical Study:	Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
Investigational Device:	The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter
Sponsor:	BioCardia, Inc.
	125 Shoreway Rd Suite B
	San Carlos, CA 94070
Consultant:	Henricus J. Duckers

As a Steering Committee (SC) consultant for the Study, I hereby disclose that I, my spouse, or dependent children have participated in financial arrangements or hold financial interests, as follows: (Check all applicable boxes.)

[  ] any financial arrangement entered into between the Sponsor of the Study, whereby the value of the compensation to me for conducting or participating in the clinical study could be influenced by the outcome of the study;

[  ] any significant payments (i.e. financial interests) of other sorts from the Sponsor of the Study that have a cumulative monetary value of $25,000 or more, including, but not limited to payments, retainers, and honoraria from Sponsor for participant on committees, providing consultation, or serving as a preceptor, grants to fund ongoing research (e.g., grants to Consultant or institution to fund Consultant’s ongoing research), compensation in the form of equipment, or honoraria;

[  ] any proprietary interest in the Investigational Device being evaluated in the Study, including but not limited to a patent, trademark, copyright or licensing agreement;

[  ] any significant equity interest in the Sponsor of the Study held by me, my spouse or dependent children.

Attach to this form the details of your financial arrangements and interests.

Henricus J. Duckers

Name of Consultant (Printed or Typed)

/s/ Henricus J. Duckers	2/15/2021
Signature of Consultant	Date

¹ A significant equity interest, as defined under 21 CFR Sec. 54.2(b), means:  (i) any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a non-publicly traded corporation); or (ii) or any equity in a publicly traded corporation that exceeds $50,000 during the time the Consultant is carrying out the study and for 1 year following completion of the study.

Page 15 of 15

BioCardia CardiAMP Study Steering Committee Consulting Agr Dr. Eric Duckers

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) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) 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

(d) 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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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, based on our most recent evaluation of internal control over financial reporting, 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 13, 2021

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

(Principal 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)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)	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
(d)	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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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, based on our most recent evaluation of internal control over financial reporting, 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 13, 2021

/s/ David McClung

Name: David McClung

Title: Chief Financial Officer

(Principal Financial Officer)

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, 2021 (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 13, 2021

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

(Principal 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 Chief Financial 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, 2021 (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 13, 2021

/s/ David McClung

Name: David McClung

Title: Chief Financial Officer

(Principal Financial Officer)

XML

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2021	May 01, 2021
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	Non-accelerated Filer
Entity Current Reporting Status	Yes
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Interactive Data Current	Yes
Entity Common Stock, Shares Outstanding (in shares)		16,792,893
Entity Shell Company	false
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
Amendment Flag	false
Title of 12(b) Security	Common Stock, par value $0.001

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 21,502	$ 21,407
Accounts receivable, net of allowance for doubtful accounts of $16 at both March 31, 2021 and December 31, 2020	190	232
Prepaid expenses and other current assets	344	401
Other receivable due from related party	623	618
Total current assets	22,659	22,658
Property and equipment, net	164	145
Operating lease right-of-use asset, net	432	567
Other assets	53	54
Total assets	23,308	23,424
Current liabilities:
Accounts payable	850	746
Accrued expenses and other current liabilities	2,248	2,205
Deferred revenue	1,180	683
Operating lease liability - current	468	614
Total liabilities	4,746	4,248
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020
Common stock, $0.001 par value, 100,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 16,792,893 and 16,297,381 shares issued and outstanding as of March 31, 2021 and December 31, 2020	17	16
Additional paid-in capital	137,588	135,234
Accumulated deficit	(119,043)	(116,074)
Total stockholders’ equity	18,562	19,176
Total liabilities and stockholders’ equity	$ 23,308	$ 23,424

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Allowance for doubtful accounts	$ 16	$ 16
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	25,000,000	25,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	16,792,893	16,297,381
Common stock, shares outstanding (in shares)	16,792,893	16,297,381

XML

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Revenue:
Total revenue	$ 46	$ 38
Costs and expenses:
Cost of goods sold		4
Research and development	1,841	2,786
Selling, general and administrative	1,177	1,857
Total costs and expenses	3,018	4,647
Operating loss	(2,972)	(4,609)
Other income (expense):
Interest income	4	16
Other expense	(1)	(1)
Total other income (expense), net	3	15
Net loss	$ (2,969)	$ (4,594)
Net loss per share, basic and diluted (in dollars per share)	$ (0.18)	$ (0.67)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	16,569,268	6,831,976
Product [Member]
Revenue:
Total revenue		$ 5
Collaboration Agreement [Member]
Revenue:
Total revenue	$ 46	$ 33

XML

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Restricted Stock Units (RSUs) [Member] Common Stock [Member]	Restricted Stock Units (RSUs) [Member] Additional Paid-in Capital [Member]	Restricted Stock Units (RSUs) [Member] Retained Earnings [Member]	Restricted Stock Units (RSUs) [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance (in shares) at Dec. 31, 2019					6,825,183
Balance at Dec. 31, 2019					$ 7	$ 103,433	$ (101,070)	$ 2,370
Restricted stock units vested and issued (in shares)	23,172
Share-based compensation						941		941
Net loss							(4,594)	(4,594)
Restricted stock units vested and issued
Balance (in shares) at Mar. 31, 2020					6,848,355
Balance at Mar. 31, 2020					$ 7	104,374	(105,664)	(1,283)
Balance (in shares) at Dec. 31, 2020					16,297,381
Balance at Dec. 31, 2020					$ 16	135,234	(116,074)	19,176
Restricted stock units vested and issued (in shares)	40,100
Sale of common stock (in shares)					453,832
Sale of common stock					$ 1	1,933		$ 1,934
Exercise of common stock options (in shares)					1,580			1,580
Exercise of common stock options						5		$ 5
Share-based compensation						416		416
Net loss							(2,969)	(2,969)
Balance (in shares) at Mar. 31, 2021					16,792,893
Balance at Mar. 31, 2021					$ 17	$ 137,588	$ (119,043)	$ 18,562

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating activities:
Net loss	$ (2,969)	$ (4,594)
Adjustments to reconcile net loss to net cash used in operating activities:
Write-off of inventory		3
Depreciation	14	22
Reduction in the carrying amount of right-of-use assets	135	118
Share-based compensation	416	941
Changes in operating assets and liabilities:
Accounts receivable	42	(32)
Inventory		1
Prepaid expenses and other current assets	57	189
Other receivable due from related party	(5)
Accounts payable	99	194
Accrued liabilities and other current liabilities	(23)	293
Deferred revenue	497	(2)
Operating lease liability - current	(146)	20
Operating lease liability - noncurrent		(146)
Net cash used in operating activities	(1,883)	(2,993)
Investing activities:
Purchase of property and equipment	(27)	(5)
Net cash used in investing activities	(27)	(5)
Financing activities:
Proceeds from sales of common stock	2,000
Proceeds from exercise of common stock options	5
Net cash provided by financing activities	2,005
Net change in cash and cash equivalents	95	(2,998)
Cash and cash equivalents at beginning of period	21,407	5,585
Cash and cash equivalents at end of period	21,502	2,587
Supplemental disclosure for noncash investing and financing activities:
Unpaid issuance costs of common stock	$ 66

XML

Note 1 - Summary of Business and Basis of Presentation

3 Months Ended

Mar. 31, 2021

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. (we, us, our, BioCardia or the Company), is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular and respiratory diseases with significant unmet medical needs. The Company's lead therapeutic candidate is the CardiAMP® Cell Therapy System, which provides an autologous bone marrow derived cell therapy for treatment in two clinical indications: heart failure that develops after a heart attack and chronic myocardial ischemia. The Company's second therapeutic platform is an investigational bone marrow derived allogeneic “off the shelf” Neurokinin- 1 Receptor Positive mesenchymal stem cell therapy for the treatment of cardiac and pulmonary disease. To date, the Company has devoted substantially all 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.
	BioCardia also 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. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

XML

Note 2 - Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

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, stockholders' equity, and cash flows as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 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 its financial position as of March 31, 2021, results of operations for the three months ended March 31, 2021 and 2020, and cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ended December 31, 2021 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, 2020, filed with the SEC on March 30, 2021.

(b)

Liquidity and Other Risks and Uncertainties

Liquidity -  The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $119.0 million as of March 31, 2021. Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as it advances its trials and development activities. Management believes cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund the Company's planned expenditures and meet its obligations for at least 12 months following the filing of this form 10 -Q.

(c)

Use of Estimates

The preparation of the financial statements in accordance with U.S. GAAP requires 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 share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, inventory valuation, and assumptions used for revenue recognition.

(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)	Changes to Significant Accounting Policies
	The Company's significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in its Annual Report on Form 10 -K filed March 30, 2021 for the year ended December 31, 2020. There have been no changes to those policies.

(f)	Recent Accounting Pronouncements
	Recent accounting pronouncements issued by the Financial Accounting Standards Board (FASB), including its Emerging Issues Task Force did not or are not believed by management to have a material impact on the Company's financial statement presentation or disclosures.

XML

Note 3 - Fair Value Measurement

3 Months Ended

Mar. 31, 2021

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 its financial assets measured on a recurring basis as of

March 31, 2021

and

December 31, 2020

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

	As of March 31, 2021
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,583	$	—	$	—	$	20,583
Cash in checking account		—		—		—		919
Total cash and cash equivalents	$	20,583	$	—	$	—	$	21,502

	As of December 31, 2020
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,662	$	—	$	—	$	20,662
Cash in checking account		—		—		—		745
Total cash and cash equivalents	$	20,662	$	—	$	—	$	21,407

XML

Note 4 - Property and Equipment, Net

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Property, Plant and Equipment Disclosure [Text Block]

( 4 ) Property and Equipment, Net

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

	March 31,			December 31,
	2021			2020
Computer equipment and software	$	166		$	159
Laboratory and manufacturing equipment		574			550
Furniture and fixtures		59			59
Leasehold improvements		332			332
Construction in progress		72			70
Property and equipment, gross		1,203			1,170
Less accumulated depreciation		(1,039	)		(1,025	)
Property and equipment, net	$	164		$	145

Depreciation expense totaled approximately

$14,000

and

$22,000

for the

three

months ended

March 31, 2021

and

2020,

respectively.

XML

Note 5 - Operating Lease Right-of-use Asset, Net

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Lessee, Operating Leases [Text Block]

( 5 ) Operating Lease Right-of-Use Asset, Net

The Company's operating lease is a property lease for its laboratory and corporate offices. BioCardia's lease agreement does

not

contain any material residual guarantees or material restrictive covenants, nor does it contain an additional lease extension. The Company determines if an arrangement is a lease at inception by assessing whether it conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

Right-of-use (ROU) assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The Company's lease does

not

provide an implicit rate. The Company used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. Variable rent expense is made up of expenses for common area maintenance and shared utilities and were

not

included in the determination of the present value of lease payments. The Company has

no

finance leases.

The lease expense for the

three

months ended

March 31, 2021

and

2020

was

$150,000

.

The cash paid under the operating lease during the

three

months ended

March 31, 2021

and

2020

was

$162,000

and

$158,000,

respectively. On

March 31, 2021,

the weighted average remaining lease term was

0.75

years, and the weighted average discount rate was

12.05%.

Future minimum lease payments under the operating lease as of

March 31, 2021

are as follows (in thousands):

	Operating Lease March 31, 2021
Remainder of 2021	$	486
Total undiscounted lease payments		486
Less imputed interest		18
Total operating lease liabilities	$	468

XML

Note 6 - Accrued Expenses and Other Current Liabilities

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Accrued Liabilities and Other Current Liabilities Disclosure [Text Block]

( 6 ) Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

	March 31,		December 31,
	2021		2020
Accrued expenses	$	240	$	87
Accrued salaries and employee benefits		851		961
Accrued clinical trial costs		457		452
Grant liability		610		615
Customer deposits		90		90
Total	$	2,248	$	2,205

XML

Note 7 - Stockholders' Equity

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

( 7 ) Stockholders '  Equity

Warrants

- Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant.

	Number of		Weighted
	Common Stock		Average
	Warrants		Exercise Price
Balance, December 31, 2020		2,424,724	$	6.36
Warrants for common stock sold		—		—
Warrants for common stock exercised		—		—
Balance, March 31, 2021		2,424,724	$	6.36

Lincoln Park Capital stock purchase agreement -

On

March 29, 2021,

the Company and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company's common stock having an aggregate value of up to

$20

million, subject to certain limitations and conditions set forth in the Purchase Agreement (the Offering). As consideration for entering into the Purchase Agreement, the Company agreed to issue to Lincoln Park

75,000

shares of common stock as commitment shares. In addition, the Company agreed to issue to Lincoln Park up to an aggregate of

50,000

additional shares of common stock as a further commitment fee based on a pro-rata percentage of the

$20

million of common stock issued to Lincoln Park under the Purchase Agreement.

Pursuant to the Purchase Agreement, Lincoln Park purchased

373,832

shares of common stock, at a price of

$5.35

per share, for a total gross purchase price of

$2

million (the Initial Purchase) and the Company issued

80,000

shares of common stock as commitment shares, which included

5,000

commitment shares issued on a pro rata basis for the initial

$2

million purchase. Thereafter, as often as every business day from and after

one

business day following the date of the Initial Purchase and over the

36

-month term of the Purchase Agreement the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to

100,000

shares of common stock, with such amount increasing as the closing price of the common stock increases; provided Lincoln Park's obligation under any single such purchase will

not

exceed

$2

million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then

may

sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company

may

direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that

may

not

exceed the lesser of (i)

300%

of the number of shares purchased pursuant to the corresponding Regular Purchase in multiple Accelerated Purchases on the same trading day or (ii) 

30%

of the total number of shares of the Company's common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company

may

direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day.

The Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is

no

upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement. In

no

event

may

the Company issue or sell to Lincoln Park under the Purchase Agreement shares of the Company's common stock in excess of

3,266,177

shares (including the commitment shares), which represents

19.99%

of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of its common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company's common stock to Lincoln Park under the Purchase Agreement equals or exceeds

$4.2736

per share. In all instances, the Company

may

not

sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than

9.99%

of its common stock.

The Purchase Agreement does

not

limit the Company's ability to raise capital from other sources at the Company's sole discretion, except that during the

36

months after the date of the Purchase Agreement (subject to certain exceptions) the Company

may

not

enter into any agreement to effect the issuance of its common stock or common stock equivalents in any “equity line of credit” or other similar continuous offering in which the Company

may

offer, issue or sell common stock or common stock equivalents at a future determined price, other than in connection with common stock issued pursuant to an “at-the-market offering” by the Company exclusively through a registered broker-dealer acting as agent of the Company pursuant to a written agreement between the Company and the registered broker-dealer. The Company has the right to terminate the Purchase Agreement at any time, at

no

cost to the Company.

As of

March 31, 2021,

the Company had

not

made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

XML

Note 8 - Share-based Compensation

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Share-based Payment Arrangement [Text Block]

( 8 ) Share-Based Compensation

The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee's respective function.

No

share-based compensation was capitalized during the periods presented. Share-based compensation expense for the

three

months ended

March 31, 2021

and

2020

was recorded as follows (in thousands):

	Three Months ended March 31,
	2021		2020
Research and development	$	206	$	413
Selling, general and administrative		210		528
Total share-based compensation	$	416	$	941

On

January 29, 2020 (

the repricing date), the Company's Board of Directors repriced certain previously granted and still outstanding vested and unvested stock option awards held by employees, executives and certain service providers of the Company; as a result, the exercise price was lowered to

$5.32

per share.

No

other terms of the repriced stock options were modified, and the repriced stock options will continue to vest according to their original vesting schedules and will retain their original expiration dates. As a result of the repricing,

515,036

vested and unvested stock options outstanding with original exercise prices ranging from

$10.05

to

$97.21,

were repriced.

The repricing on

January 29, 2020

resulted in incremental stock-based compensation expense of

$569,000,

of which

$412,000

related to vested employee stock option awards and was expensed on the repricing date, and

$157,000

related to unvested stock option awards is being amortized on a straight-line basis over the approximately

three

year remaining weighted average vesting period of those awards.

The following table summarizes the activity of stock options and related information:

	Options outstanding
	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrisinsic value (in thousands)
Balance, December 31, 2020		1,114,306		$	5.89		7.5	$	177.1
Stock options granted		18,850			4.63
Stock options exercised		(1,580	)		2.49
Stock options forfeited		(44,643	)		4.30
Stock options expired		(125	)		5.32
Balance, March 31, 2021		1,086,808		$	5.94		6.9	$	423.8
Exercisable, March 31, 2021		661,430		$	7.29		5.6	$	73.0

Unrecognized share-based compensation for employee and nonemployee options granted through

March 31, 2021

is approximately

$1.7

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

2.2

years.

Share-Based Compensation (RSUs)

The following summarizes the activity of non-vested RSUs:

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2020		224,311		$	4.12
RSUs granted		18,792			4.34
RSUs released		(40,100	)		4.20
Balance, March 31, 2021		203,003		$	4.12

Unrecognized share-based compensation for employee and nonemployee RSUs granted through

March 31, 2021

is approximately

$24,000

to be recognized over a remaining weighted average service period of

2.1

years.

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Note 9 - Net Loss Per Share

3 Months Ended

Mar. 31, 2021

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. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is

no

difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to its net loss position.

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,		December 31,
	2021		2020
Stock options to purchase common stock		1,086,808		1,114,306
Unvested restricted stock units		8,200		8,200
Common stock warrants		2,424,724		2,424,724
Total		3,519,732		3,547,230

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Note 10 - Income Taxes

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Income Tax Disclosure [Text Block]

( 10 ) Income Taxes

During the

three

months ended

March 31, 2021

and

2020,

there was

no

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

As of

March 31, 2021,

the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of its 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 - Related Party Transactions

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Related Party Transactions Disclosure [Text Block]

( 11 ) Related Party Transactions

On

April 9, 2020,

the Company entered into a Litigation Funding Agreement (the Funding Agreement) with BSLF, L.L.C. (the Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia's board of directors, for the purpose of funding the Company's legal proceedings and any and all claims, actions and/or proceedings relating to or arising from the case captioned Boston Scientific Corp., et al., v. BioCardia Inc., Case

No.

3:19

-

05645

-VC, U.S.D.C., N. D. Cal (the Litigation). BioCardia sought imposition of constructive trusts both on the patents naming Ms. Sarna as an inventor and the proceeds received from the sale of nVision to Boston Scientific, as well as damages, including unjust enrichment damages measured by the proceeds received from the sale of nVision to Boston Scientific.

Under the terms of the Funding Agreement, the Funder agreed to fund the legal fees and costs incurred by the Company in connection with the Litigation on and after

March 1, 2020

on a non-recourse basis. The Company agreed to repay the Funder from any proceeds arising from the Litigation (the Litigation Proceeds), (i) any taxes paid by or imposed upon Funder (other than taxes imposed upon Funder as a consequence of Funder's income) with respect to the claims, the litigation proceeds or as a consequence of any settlement in connection with the Litigation, if any, plus (ii) an amount, without reduction, set-off or counterclaim, equal to the amount actually paid by the Funder pursuant to the Funding Agreement (the Actual Funding Amount) plus (iii) the greater of:

(a)

50%

of the remaining Litigation Proceeds, up to

three

times the Actual Funding Amount; or

(b)

30%

of the remaining Litigation Proceeds.

Although the Company is required under the terms of the Funding Agreement to consult with the Funder regarding any settlement in connection with the Litigation and to allow Funder to participate in any real-time settlement negotiations, the Company has the sole and exclusive right to settle on whatever terms it deems acceptable. 

The Funding Agreement

may

be terminated by Funder upon

ten

days' written notice to the Company. Funder is obligated to fund only the fees and costs incurred in the Litigation through the end of the month in which the termination notice was served. The Company

may

terminate the agreement upon

ten

days' written notice to Funder from and after a failure by Funder to fulfill its obligations under the Funding Agreement if such failure or material breach is continuing at the end of such

ten

-day period. Under the terms of the agreement, the total due from the related party as of

March 31, 2021

was approximately

$623,000.

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Note 12 - Concentrations and Uncertainties

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Concentration Risk Disclosure [Text Block]

( 12 ) Contingencies and Uncertainties

Contingencies

 - 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 is

not

aware of any current legal or administrative proceedings that are likely to have an adverse effect on the Company's business, financial position, results of operations, or cash flows.

Uncertainties

 - The results for the

three

months ended

March 31, 2021

are

not

necessarily indicative of the results to be expected for the year ending

December 31, 2021

or for any other interim period or for any other future year, particularly in light of the novel coronavirus pandemic, or COVID-

19,

and its impact on domestic and global economies. To limit the spread of COVID-

19,

governments have taken various actions including the issuance of stay-at-home orders and social distancing guidelines, causing some businesses to suspend operations and/or experience a reduction in demand for many products from direct or ultimate customers. Accordingly, businesses have adjusted, reduced or suspended operating activities and are continuing to adapt to these changing actions and guidelines.

Beginning

March 17, 2020,

substantially all of the Company's workforce began working from home. On

April 6, 2020,

manufacturing operations resumed at the Company's facilities, with a number of other staff continuing to work from home. While the direct effects of the stay-at-home orders and BioCardia's work-from-home policies have been largely mitigated as of

March 31, 2021,

the overall impact of the pandemic resulted in disruption to the Company's business and in delays in the Company's development programs and regulatory and commercialization timelines. The overall magnitude of the continuing impact will depend, in part, on the length and severity of changing restrictions and other limitations on BioCardia's ability to conduct the Company's business. BioCardia's future research and development expenses and general and administrative expenses

may

vary significantly if the Company experiences an increased impact from COVID-

19

on the costs and timing associated with the conduct of BioCardia's clinical trials and other related business activities. 

As the outbreak continues to mutate and spread, it

may

affect the Company's operations and those of

third

parties on which the Company relies, including causing disruptions in the supply of the Company's product candidates and the conduct of current and planned preclinical and clinical studies. BioCardia

may

need to limit operations and

may

experience limitations in employee resources. There are risks that the COVID-

19

outbreak

may

be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly. The extent to which the coronavirus impacts the Company's results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which

may

emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

Additionally, while the potential economic impact brought by, and the duration of, a coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus on the global financial markets

may

reduce the Company's ability to access capital, which could negatively impact the Company's short-term and long-term liquidity, and the Company's ability to complete its preclinical and clinical studies on a timely basis, or at all. The Company was successful in raising additional funding in

2020.

However, the ultimate impact of coronavirus is highly uncertain and subject to change. The Company does

not

yet know the full extent of potential delays or impacts on its business, financing, preclinical and clinical trial activities or the global economy as a whole. However, these effects could have a material, adverse impact on the Company's liquidity, capital resources, operations and business and those of the

third

parties on which BioCardia relies.

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Note 13 - Subsequent Events

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Subsequent Events [Text Block]

( 13 ) Subsequent Events

On

April 12, 2021,

all parties to the Litigation entered into a confidential settlement agreement. All claims in the Litigation have been dismissed. The settlement did

not

result in any material benefit or liability to the Company. The Company expects to terminate the Funding Agreement once all remaining matters thereunder are concluded.

On

April 26, 2021,

the Company issued a press release announcing that it has entered into an agreement with a leading Japanese biotechnology company related to the Company's Helix catheter biotherapeutic delivery product candidates. This is the

second

new biotherapeutic delivery partnership for the Company in

2021.

Under the terms of the agreement, the Company will receive

$500,000,

a portion of which is creditable for biotherapeutic delivery products and support services. The agreement has a

one

-year term with an option for the Japanese biotechnology company to negotiate a non-exclusive worldwide license for therapeutic delivery of certain cell types for cardiac indications.

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Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Basis of Accounting, Policy [Policy Text Block]

(a)

Basis of Preparation

       

The accompanying condensed consolidated balance sheets, statements of operations, stockholders' equity, and cash flows as of

March 31, 2021

and for the

three

months ended

March 31, 2021

and

2020

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 its financial position as of

March 31, 2021,

results of operations for the

three

months ended

March 31, 2021

and

2020,

and cash flows for the

three

months ended

March 31, 2021

and

2020.

The results for the

three

months ended

March 31, 2021

are

not

necessarily indicative of the results to be expected for the year ended

December 31, 2021

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, 2020,

filed with the SEC on

March 30, 2021. 

Going Concern and Liquidity [Policy Text Block]

(b)

Liquidity and Other Risks and Uncertainties

Liquidity -  The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $119.0 million as of March 31, 2021. Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as it advances its trials and development activities. Management believes cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund the Company's planned expenditures and meet its obligations for at least 12 months following the filing of this form 10 -Q.

Use of Estimates, Policy [Policy Text Block]

 

(c)

Use of Estimates

       

The preparation of the financial statements in accordance with U.S. GAAP requires 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 share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, inventory valuation, and assumptions used for revenue recognition.

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.

Change to Significant Accounting Policies [Policy Text Block]

(e)	Changes to Significant Accounting Policies
	The Company's significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in its Annual Report on Form 10 -K filed March 30, 2021 for the year ended December 31, 2020. There have been no changes to those policies.

New Accounting Pronouncements, Policy [Policy Text Block]

(f)	Recent Accounting Pronouncements
	Recent accounting pronouncements issued by the Financial Accounting Standards Board (FASB), including its Emerging Issues Task Force 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, 2021

Notes Tables

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

	As of March 31, 2021
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,583	$	—	$	—	$	20,583
Cash in checking account		—		—		—		919
Total cash and cash equivalents	$	20,583	$	—	$	—	$	21,502

	As of December 31, 2020
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,662	$	—	$	—	$	20,662
Cash in checking account		—		—		—		745
Total cash and cash equivalents	$	20,662	$	—	$	—	$	21,407

XML

Note 4 - Property and Equipment, Net (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

Property, Plant and Equipment [Table Text Block]

	March 31,			December 31,
	2021			2020
Computer equipment and software	$	166		$	159
Laboratory and manufacturing equipment		574			550
Furniture and fixtures		59			59
Leasehold improvements		332			332
Construction in progress		72			70
Property and equipment, gross		1,203			1,170
Less accumulated depreciation		(1,039	)		(1,025	)
Property and equipment, net	$	164		$	145

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Note 5 - Operating Lease Right-of-use Asset, Net (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

Lessee, Operating Lease, Liability, Maturity [Table Text Block]

	Operating Lease March 31, 2021
Remainder of 2021	$	486
Total undiscounted lease payments		486
Less imputed interest		18
Total operating lease liabilities	$	468

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Note 6 - Accrued Expenses and Other Current Liabilities (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block]

	March 31,		December 31,
	2021		2020
Accrued expenses	$	240	$	87
Accrued salaries and employee benefits		851		961
Accrued clinical trial costs		457		452
Grant liability		610		615
Customer deposits		90		90
Total	$	2,248	$	2,205

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Note 7 - Stockholders' Equity (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]

	Number of		Weighted
	Common Stock		Average
	Warrants		Exercise Price
Balance, December 31, 2020		2,424,724	$	6.36
Warrants for common stock sold		—		—
Warrants for common stock exercised		—		—
Balance, March 31, 2021		2,424,724	$	6.36

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Note 8 - Share-based Compensation (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

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

	Three Months ended March 31,
	2021		2020
Research and development	$	206	$	413
Selling, general and administrative		210		528
Total share-based compensation	$	416	$	941

Share-based Payment Arrangement, Option, Activity [Table Text Block]

	Options outstanding
	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrisinsic value (in thousands)
Balance, December 31, 2020		1,114,306		$	5.89		7.5	$	177.1
Stock options granted		18,850			4.63
Stock options exercised		(1,580	)		2.49
Stock options forfeited		(44,643	)		4.30
Stock options expired		(125	)		5.32
Balance, March 31, 2021		1,086,808		$	5.94		6.9	$	423.8
Exercisable, March 31, 2021		661,430		$	7.29		5.6	$	73.0

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

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2020		224,311		$	4.12
RSUs granted		18,792			4.34
RSUs released		(40,100	)		4.20
Balance, March 31, 2021		203,003		$	4.12

XML

Note 9 - Net Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2021

Notes Tables

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

	March 31,		December 31,
	2021		2020
Stock options to purchase common stock		1,086,808		1,114,306
Unvested restricted stock units		8,200		8,200
Common stock warrants		2,424,724		2,424,724
Total		3,519,732		3,547,230

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Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Retained Earnings (Accumulated Deficit), Ending Balance	$ (119,043)	$ (116,074)
Cash and Cash Equivalents, at Carrying Value, Ending Balance	$ 21,502	$ 21,407

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Note 3 - Fair Value Measurement - Fair Value of Assets Measured on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents, Fair Value	$ 21,502	$ 21,407
Money Market Funds [Member]
Cash and Cash Equivalents, Fair Value	20,583	20,662
Demand Deposits [Member]
Cash and Cash Equivalents, Fair Value	919	745
Fair Value, Inputs, Level 1 [Member]
Cash and Cash Equivalents, Fair Value	20,583	20,662
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member]
Cash and Cash Equivalents, Fair Value	20,583	20,662
Fair Value, Inputs, Level 1 [Member] | Demand Deposits [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 2 [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 2 [Member] | Demand Deposits [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 3 [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member]
Cash and Cash Equivalents, Fair Value
Fair Value, Inputs, Level 3 [Member] | Demand Deposits [Member]
Cash and Cash Equivalents, Fair Value

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Note 4 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Depreciation, Total	$ 14,000	$ 22,000

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Note 4 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Property and equipment, gross	$ 1,203	$ 1,170
Less accumulated depreciation	(1,039)	(1,025)
Property and equipment, net	164	145
Computer Equipment and Software [Member]
Property and equipment, gross	166	159
Laboratory and Manufacturing Equipment [Member]
Property and equipment, gross	574	550
Furniture and Fixtures [Member]
Property and equipment, gross	59	59
Leasehold Improvements [Member]
Property and equipment, gross	332	332
Construction in Progress [Member]
Property and equipment, gross	$ 72	$ 70

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Note 5 - Operating Lease Right-of-use Asset, Net (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating Lease, Expense	$ 150,000	$ 150,000
Operating Lease, Payments	$ 162,000	$ 158,000
Operating Lease, Weighted Average Remaining Lease Term (Year)	273 days
Operating Lease, Weighted Average Discount Rate, Percent	12.05%

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Note 5 - Operating Lease Right-of-use Asset, Net - Future Minimum Lease Payments Under Operating Lease (Details) $ in Thousands	Mar. 31, 2021 USD ($)
Remainder of 2021	$ 486
Total undiscounted lease payments	486
Less imputed interest	18
Total operating lease liabilities	$ 468

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Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Accrued expenses	$ 240	$ 87
Accrued salaries and employee benefits	851	961
Accrued clinical trial costs	457	452
Grant liability	610	615
Customer deposits	90	90
Total	$ 2,248	$ 2,205

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Note 7 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands			3 Months Ended
	Mar. 31, 2021	Mar. 29, 2021	Mar. 31, 2021	Mar. 31, 2020
Proceeds from Issuance of Common Stock			$ 2,000
Purchase Agreement with Lincoln Park [Member]
Sale of Stock, Aggregate Value, Maximum		$ 20,000
Stock Issuable, Shares, Commitment Fess (in shares)		75,000
Stock Issuable, Commitment Shares on Pro Rata Basis (in shares)		50,000
Stock Issued During Period, Shares, New Issues (in shares)	0	373,832
Shares Issued, Price Per Share (in dollars per share)		$ 5.35
Proceeds from Issuance of Common Stock		$ 2,000
Stock Issued During the Period, Shares, Commission Fees (in shares)		80,000
Stock Issued During the Period, Commitment Shares Issued on Pro Rata Basis (in shares)		5,000
Conditional Issuance, Maximum Number of Shares Allowed to be Purchased (in shares)		100,000
Stock Purchase Agreement Accelerated Purchase, Maximum, Percent of Shares Purchased on the Same Trading Day		300.00%
Stock Purchase Agreement Accelerated Purchase, Maximum, Percent of Total Common Shares Traded During Specified Period		30.00%
Maximum Number of Shares Allowed to be Issued Including Commitment Shares (in shares)		3,266,177
Percentage of Common Stock Outstanding		19.99%

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Note 7 - Stockholders' Equity - Warrants (Details)	3 Months Ended
	Mar. 31, 2021 $ / shares shares
Balance, beginning (in shares) | shares	2,424,724
Balance, beginning, weighted average exercise price (in dollars per share) | $ / shares	$ 6.36
Warrants for common stock sold (in shares) | shares
Warrants for common stock sold, weighted average exercise price (in dollars per share) | $ / shares
Warrants for common stock exercised (in shares) | shares
Warrants for common stock exercised, weighted average exercise price (in dollars per share) | $ / shares
Balance, ending (in shares) | shares	2,424,724
Balance, ending, weighted average exercise price (in dollars per share) | $ / shares	$ 6.36

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Note 8 - Share-based Compensation (Details Textual) - USD ($)		3 Months Ended
	Jan. 29, 2020	Mar. 31, 2021	Mar. 31, 2020
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)	$ 5.32	$ 4.63
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares)	515,036	18,850
Share-based Payment Arrangement, Expensed and Capitalized, Amount, Total	$ 569,000
Share-based Payment Arrangement, Expense	412,000	$ 416,000	$ 941,000
Share-based Payment Arrangement, Amount Capitalized	$ 157,000
Share-based Compensation Arrangement by Share-based Payment Award, Remaining Weighted Average Award Vesting Period (Year)	3 years
Non-employee Directors and Employees [Member]
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount		$ 1,700,000
Non-employee Directors and Employees [Member] | Share-based Payment Arrangement, Option [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)		2 years 73 days
Non-employee Directors and Employees [Member] | Restricted Stock Units (RSUs) [Member]
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)		2 years 36 days
Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount		$ 24,000
Minimum [Member]
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)	$ 10.05
Maximum [Member]
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)	$ 97.21

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Note 8 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($)		3 Months Ended
	Jan. 29, 2020	Mar. 31, 2021	Mar. 31, 2020
Share-based compensation expense	$ 412,000	$ 416,000	$ 941,000
Research and Development Expense [Member]
Share-based compensation expense		206,000	413,000
Selling, General and Administrative Expenses [Member]
Share-based compensation expense		$ 210,000	$ 528,000

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Note 8 - Share-based Compensation - Stock Option Activity (Details) - USD ($)		3 Months Ended	12 Months Ended
	Jan. 29, 2020	Mar. 31, 2021	Dec. 31, 2020
Stock options outstanding, beginning of period (in shares)		1,114,306
Balance, weighted average exercise price, beginning of period (in dollars per share)		$ 5.89
Stock options outstanding, weighted average remaining contractual term (Year)		6 years 328 days	7 years 182 days
Stock options outstanding, aggregate intrinsic value		$ 423,800	$ 177,100
Stock options granted (in shares)	515,036	18,850
Stock options granted, weighted average exercise price (in dollars per share)	$ 5.32	$ 4.63
Stock options exercised (in shares)		(1,580)
Stock options exercised, weighted average exercise price (in dollars per share)		$ 2.49
Stock options forfeited (in shares)		(44,643)
Stock options forfeited, weighted average exercise price (in dollars per share)		$ 4.30
Stock options expired (in shares)		(125)
Stock options expired, weighted average exercise price (in dollars per share)		$ 5.32
Stock options outstanding, end of period (in shares)		1,086,808	1,114,306
Balance, weighted average exercise price, end of period (in dollars per share)		$ 5.94	$ 5.89
Exercisable, March 31, 2021 (in shares)		661,430
Options exercisable, weighted average exercise price (in dollars per share)		$ 7.29
Options exercisable, weighted average remaining contractual term (Year)		5 years 219 days
Options exercisable, aggregate intrinsic value		$ 73,000

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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, 2021 $ / shares shares
Balance, shares (in shares) | shares	224,311
Balance, weighted average grant date fair value per share (in dollars per share) | $ / shares	$ 4.12
RSUs granted, shares (in shares) | shares	18,792
RSUs granted, weighted average grant date fair value per share (in dollars per share) | $ / shares	$ 4.34
RSUs released (in shares) | shares	(40,100)
RSUs released (in dollars per share) | $ / shares	$ 4.20
Balance, shares (in shares) | shares	203,003
Balance, weighted average grant date fair value per share (in dollars per share) | $ / shares	$ 4.12

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Note 9 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Antidilutive securities (in shares)	3,519,732	3,547,230
Share-based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)	1,086,808	1,114,306
Restricted Stock Units (RSUs) [Member]
Antidilutive securities (in shares)	8,200	8,200
Warrant [Member]
Antidilutive securities (in shares)	2,424,724	2,424,724

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Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Income Tax Expense (Benefit), Total	$ 0	$ 0

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Note 11 - Related Party Transactions (Details Textual) - BSLF, L.L.C. [Member] - Funding Agreement [Member]	3 Months Ended
	Mar. 31, 2021 USD ($)
Percentage of Remaining Litigation Proceeds Up to Three Times the Actual Funding Amount	50.00%
Percentage of Remaining Litigation Proceeds	30.00%
Agreement Termination Period (Day)	10 days
Due from Related Parties, Total	$ 623,000

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Note 13 - Subsequent Events (Details Textual)	Apr. 26, 2021 USD ($)
Helix Biotherapeutic Delivery System [Member] | Subsequent Event [Member]
Proceeds From Agreement	$ 500,000