BCDA BioCardia Inc

Part I.	FINANCIAL INFORMATION	4
Item 1.	Unaudited Condensed Consolidated Financial Statements	4
	Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022	4
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2023 and 2022	5
	Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022	6
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4.	Controls and Procedures	23
Part II.	OTHER INFORMATION	24
Item 1.	Legal Proceedings	24
Item 1A.	Risk Factors	24
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25
Item 3.	Defaults Upon Senior Securities	25
Item 4.	Mine Safety Disclosures	25
Item 5.	Other Information	25
Item 6.	Exhibits	25
EXHIBIT INDEX		25
SIGNATURES		26

 

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, 2022, which is incorporated by reference herein, 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.

 

 

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)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

 

(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 company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our neurokinin-1 receptor positive (NK1R+) allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS). Our autologous CardiAMP and our allogeneic NK1R+ cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property.
		We manage our 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 June 30, 2023, and for the three and six months ended June 30, 2023 and 2022 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 June 30, 2023, results of operations for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ended December 31, 2023 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 our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 29, 2023.

 

	(b)	Liquidity – Going Concern
		We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $147.5 million as of June 30, 2023. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $4.3 million as of June 30, 2023 are not sufficient to fund the Company’s planned expenditures and meet its obligations beyond the fourth quarter of 2023. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.   Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond the fourth quarter of 2023 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. If adequate funds are not available, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, or cease operations.

 

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	(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, clinical accruals 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, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.

 

	(e)	Concentration of Credit Risk
		Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On June 30, 2023, approximately 99% of our cash was held by one financial institution and total amounts on deposit were approximately $4.0 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.   Silicon Valley Bank (SVB) was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. On March 12, 2023, a joint statement was issued by the Secretary of the Treasury and the Federal Reserve and the FDIC Chairman stating that all depositors would be fully protected and would have access to both insured and uninsured deposits starting March 12, 2203. The FDIC then established a bridge bank successor, Silicon Valley Bridge Bank, N.A., which quickly assumed ongoing business. On March 27, 2023, First Citizens Bank & Trust Company, a subsidiary of First Citizens BancShares, assumed all customer deposits and acquired all loans of Silicon Valley Bridge Bank from the FDIC and began operating all SVB branches. As of March 31, 2023, the Company transferred substantially all of its cash and cash equivalents from SVB to another financial institution and does not believe it will be impacted by the transition of SVB to First Citizens Bank & Trust Company.

 

	(f)	Changes to Significant Accounting Policies
		Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed March 29, 2023. There have been no changes to those policies.

 

	(g)	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 our financial statement presentation or disclosures.

 

(3)	Fair Value Measurement

 

The fair value of financial instruments reflects the amounts that we estimate 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). We follow 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.

 

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

 

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

 

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

 

		As of June 30, 2023
		Level 1				Level 2				Level 3				Total
Assets:
Money market funds		$	20			$	—			$	—			$	20
Cash in savings account			—				—				—				3,886
Cash in checking account			—				—				—				399
Total cash and cash equivalents		$	20			$	—			$	—			$	4,305

 

		As of December 31, 2022
		Level 1				Level 2				Level 3				Total
Assets:
Money market funds		$	6,893			$	—			$	—			$	6,893
Cash in checking account			—				—				—				470
Total cash and cash equivalents		$	6,893			$	—			$	—			$	7,363

 

(4)	Property and Equipment, Net

 

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

 

		June 30,				December 31,
		2023				2022
Computer equipment and software		$	174			$	161
Laboratory and manufacturing equipment			574				575
Furniture and fixtures			27				27
Leasehold improvements			26				26
Property and equipment, gross			801				789
Less accumulated depreciation			(662	)			(619	)
Property and equipment, net		$	139			$	170

 

Depreciation expense totaled $21,000 and $43,000 for the three and six months ended June 30, 2023, respectively. Depreciation expense totaled $16,000 and $32,000 for the three and six months ended June 30, 2022, respectively.

  

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

 

In December 2021, we entered into a lease related to a property lease for our laboratory and corporate offices, which expires in January 2027, with an option for us to extend a further 36 months after expiration. Our lease agreements do not contain any material residual guarantees or material restrictive covenants. We determine 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. We 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. We have no finance leases.

 

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Our lease expense was $120,000 and $241,000 for the three and six months ended June 30, 2023, respectively. Our lease expense for the three and six months ended June 30, 2022 was $120,000 and $241,000, respectively. The cash paid under the operating lease for base rent for the three and six months ended June 30, 2023 was $118,000 and $236,000, respectively. The cash paid under the operating lease for base rent for the three and six months ended June 30, 2022 was $76,000 and $173,000, respectively. On June 30, 2023, the weighted average remaining lease term was 3.59 years, and the weighted average discount rate was 10.74%.

 

Future minimum lease payments under the operating lease as of June 30, 2023 were as follows (in thousands):

 

Remainder of 2023		$	236
2024			485
2025			499
2026			514
2027			44
Total undiscounted lease payments		$	1,778
Less imputed interest			300
Total operating lease liabilities		$	1,478

 

(6)	Accrued Expenses and Other Current Liabilities

 

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

 

		June 30,				December 31,
		2023				2022
Accrued expenses		$	111			$	157
Accrued salaries and employee benefits			715				899
Accrued clinical trial costs			821				548
Grant liability			501				534
Customer deposits			90				90
Payable to related party			19				18
Total		$	2,257			$	2,246

 

(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 as of December 31, 2022			2,424,724			$	6.36
Warrants for common stock sold			—				—
Warrants for common stock exercised			—				—
Balance as of June 30, 2023			2,424,724			$	6.36

 

June 2023 Financing - On June 21, 2023, we sold to certain existing investors and other institutional investors, as well as certain directors and officers of the Company (the Purchasers) 1,133,141 shares of our common stock in a registered direct offering (the Offering) at an offering price of $2.336 per share. Certain of the Company’s directors and executive officers purchased an aggregate of 203,337 of such shares. The gross proceeds of the Offering were approximately $2.6 million, with associated issuance costs of approximately $177,000.

 

Cantor Fitzgerald Sales agreement - On April 12, 2022, we entered into a sales agreement (Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). We are not obligated to sell any common stock shares pursuant to the Sales Agreement. Under the terms of the Sales Agreement, we pay Cantor a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees. We filed a prospectus supplement under our existing registration statement covering the offer and sale of up to $10.5 million of common stock, of which approximately $8.4 million was still available for offer and sale as of June 30, 2023.

 

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During the three and six months ended June 30, 2023, we sold 28,599 and 134,840 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $58,000 and $302,000, with net issuance costs of approximately $29,000 and $42,000, respectively. During both the three and six months ended June 30, 2022, we sold 575,000 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $1.5 million, with net issuance costs of approximately $232,000.

 

Lincoln Park Capital stock purchase agreement - On March 29, 2021, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park) (Purchase Agreement) and a registration rights agreement (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 in the Purchase Agreement.

 

Pursuant to the Purchase Agreement in March 2021, 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 (Initial Purchase) and we 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.

 

As of June 30, 2023, we had not sold any common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. On June 30, 2023, we provided notice to Lincoln Park of our election to terminate the Purchase Agreement. Following such termination, which was effective July 3, 2023, we may not sell any further shares of our common stock under the Purchase Agreement.

 

(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 and six months ended June 30, 2023 and 2022 was recorded as follows (in thousands):

 

		Three months ended								Six months ended
		June 30,								June 30,
		2023				2022				2023				2022
Research and development		$	134			$	130			$	273			$	257
Selling, general and administrative			183				174				322				366
Total share-based compensation		$	317			$	304			$	595			$	623

 

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 intrinsic value (in thousands)
Balance, December 31, 2022			2,182,708			$	4.04				7.5			$	343
Stock options granted			543,513				1.69
Stock options exercised			(199	)			1.49
Stock options forfeited			(119,941	)			2.36
Balance, June 30, 2023			2,606,081			$	3.63				7.3			$	1,189
Exercisable, June 30, 2023			1,443,515			$	4.83				6.0			$	315

 

Unrecognized share-based compensation for employee and nonemployee options granted through June 30, 2023 is approximately $2.1 million to be recognized over a remaining weighted average service period of 2.7 years.

 

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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, 2022			21,526			$	4.33
RSUs granted			331,552				1.70
RSUs released			(241,197	)			1.93
RSUs forfeited			(111,881	)			1.70
Balance, June 30, 2023			—			$	n/a

 

RSUs vested and settled are converted into our common stock on a one-for-one basis. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The related compensation expense, which is based on the grant date fair value of our common stock multiplied by the number of units granted, is recognized ratably over the period during which the vesting restrictions lapse. Unrecognized share-based compensation for employee and nonemployee RSUs granted through June 30, 2023 was $0.

 

(9)	Net Loss per Share

 

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. 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 the 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:

 

		June 30,
		2023				2022
Stock options to purchase common stock			2,606,081				2,060,836
Unvested restricted stock units			—				2,734
Common stock warrants			2,424,724				2,424,724
Total			5,030,805				4,488,294

 

(10)	Income Taxes

 

During the three and six months ended June 30, 2023 and 2022, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to our net loss and a full valuation allowance on the resulting deferred tax assets.

 

As of June 30, 2023, we retain a full valuation allowance on our deferred tax assets in all jurisdictions. The realization of our deferred tax assets depends primarily on our ability to generate future taxable income which is uncertain. We do not believe that our 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, we entered into a Litigation Funding Agreement (Funding Agreement) with BSLF, L.L.C. (Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding our 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). On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement and all claims were dismissed.

 

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In March 2022, we entered into settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude on all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the confidential agreements, litigation and corporate counsel provided credits and refunds of legal fees totaling $688,000, which offset the amounts owed to us by the Funder under the Funding Agreement, and provided up to $300,000 in future discounts on legal services. As a result of the Litigation Funding Settlement, we will remit the discounts, as received, to the Funder on a quarterly basis. During the three and six months ended June 30, 2023, we received discounts totaling $20,000 and $53,000, respectively. During the three and six months ended June 30, 2022, we received discounts totaling $43,000 and $47,000, respectively. As of June 30, 2023 and December 31, 2022, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $19,000 and $18,000, respectively. As of June 30, 2023, up to $168,455 future potential discounts are due to the Funder.

 

(12)	Contingencies and Uncertainties

 

Contingencies - We 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 our business, financial position, results of operations, or cash flows.

 

Uncertainties - The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future year, particularly in light of COVID-19 and its impact on domestic and global economies. Governmental and business reactions to the pandemic, and resulting economic disruptions, have the potential to materially impact our business and influence our business decisions. While the impact of COVID-19 did not have a material adverse effect on our financial position or results of operations for the periods presented, our future assessment of the magnitude and duration of COVID-19 and related factors, could result in material impacts to our financial statements in future reporting periods. As of June 30, 2023, up to $168,455 future potential discounts are due to the Funder.

 

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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 Quarterly 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 (v) 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, 2022, which is incorporated by reference herein. 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 company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our neurokinin-1 receptor positive (NK1R+) allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS).

 

Our autologous CardiAMP and our allogeneic NK1R+ cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We selectively partner this therapeutic delivery platform with others seeking to develop biotherapeutic interventions for local delivery to the heart.

 

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

 

CardiAMP Autologous Cell Therapy for Ischemic Heart Failure (BCDA-01) and for Chronic Myocardial Ischemia (BCDA-02)

 

The CardiAMP Cell Therapy Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers in the United States and Canada, which includes a 10-patient roll-in cohort. The Phase III pivotal trial, which was granted Breakthrough designation by the U.S. Food and Drug Administration (FDA), is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for the treatment of heart failure with HFrEF (BCDA-01). The primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in 6MW at 12 months. Additional prespecified secondary hierarchical and nonhierarchical endpoints are also being assessed. This trial is active at 20 clinical sites, including four sites in Canada and 121 patients have been enrolled to date.

 

Working with leading biostatistics and regulatory consultants, we submitted a supplement to the FDA in February 2023 with a proposed adaptive SAP for the CardiAMP Heart Failure trial. This was submitted as a Sprint Discussion under the Breakthrough designation guidance provided by the FDA. We met with the FDA CBER on March 29, 2023, documented the minutes of our discussion with the FDA and on April 26, 2023 submitted a detailed supplement for the implementation of an adaptive statistical analysis plan. In June 2023, the FDA completed its review.

 

 

On July 12, 2023, the planned Data Safety Monitoring Board (DSMB) meeting was held utilizing the adaptive statistical analysis plan reviewed by FDA in Q2.  On July 24, 2023, the Company announced that the DSMB had completed its review and recommended that the Company pause the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated.

 

The DSMB panel includes two cardiologists with experience in heart failure and interventional cardiology and a biostatistician experienced in evaluating trial data for chronic diseases, including heart failure. The mission of the DSMB is to ensure patient safety and to promote/monitor the quality and integrity of the data.  Their primary responsibility is to ensure patient safety and to halt or pause the clinical investigation if the risk of the therapy appears to outweigh its potential benefit. Such risk-benefit analysis typically includes an analysis of futility to reach the primary endpoint of the clinical trial as designed. 

 

The DSMB reviewed an initial analysis of the unblinded data and concluded that the trial was unlikely to meet its primary FS composite endpoint, even though the prespecified criteria for termination of the trial had not been met. This initial analysis excluded patients who had not yet made it to 12-month follow-up. The DSMB also cited the slow rate of enrollment in the trial. Additional data was subsequently provided to the DSMB including, we believe: (1) statistical analysis prepared strictly in accordance with the prespecified data review plan, which had not initially been provided to the DSMB, (2) analysis of health outcomes as measured by endpoints other than the six-minute walk, and (3) information on the increased enrollment rates across many clinical centers. After consideration of the additional data, the DSMB recommended that the Company pause enrollment of new patients pending the 12-month outcomes analysis for all patients, and that the Company continue to treat patients already enrolled in the trial. The DSMB also recommended that the data blind be preserved so that the trial may be continued following analysis of the twelve-month follow-up data for all enrolled patients. 

 

The DSMB interim review was based on available data for 132 procedures involving 111 randomized patients, including treated patients and the control group. The pre-specified statistical analysis plan provided that the DSMB would utilize a composite endpoint that considered survival, major adverse cardiac and cerebrovascular events (MACCE), and six-minute walk distance at 12 months. This is the FS composite endpoint for the study. The pre-specified interim analysis did not impute data for patients who had not performed the six-minute walk, either because they were not yet at the one-year follow-up date or because of orthopedic or other health issues as will be done in the final statistical analysis per plan.  The pre-specified interim statistical analysis did not include other endpoints that are part of the trial, including assessment of patient status using the New York Heart Association classification, quality of life measured using the Minnesota Living with Heart Failure questionnaire, and heart function assessment such as left ventricular ejection fraction.

 

The blinded data report available to the Company for the 96 randomized patients with 12-month outcome measures available for the most recent DSMB review, groups together all patients, including treated and control patients. That blinded data shows better than expected patient survival, improvement in mean six-minute walk distance, improvement in NYHA class, improvement in quality of life and improvement in left ventricular ejection fraction.  The blinded data does not disclose the difference in outcomes between the treated group and the control group of patients. An estimated additional 25 randomized patients will be included in final trial results should the trial not be restarted.  This estimate includes ten (10) patients in the queue expected to be randomization in the trial in the next six weeks, nine (9) randomized patients who have not yet reached the 12-month follow-up visit, and six (6) patients who were unable to walk at 12-months due to other non-cardiac issues.  Results will not be available until the last patient reaches their 12-month follow-up visit.

 

An external statistics consultancy has completed a quality review on the primary endpoint interim data analysis provided to the DSMB.  We are working to enable this replicate analysis and the closed session DSMB information to be reviewed by a clinical consultant to make recommendations on next steps.  If there are reasons to engage the DSMB, discussions between the DSMB and the unblinded consultants may take place.  Once this quality review is completed by this external unblinded group, expected in Q3, it is anticipated that a segregated BioCardia team will be unblinded to the data in order to provide strategic guidance for this program ahead.  If the Company obtains material new information from this review, it will be shared publicly as appropriate.

 

In June 2023, we completed our submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF) based on existing safety and efficacy data. In July, the formal consultation was reviewed and accepted by the PMDA for the consultation with some clarifying questions which have been addressed. The PMDA consultation could take up to four months to schedule, although dates in September have been requested.  Subsequent interactions with PMDA are expected.  The CardiAMP Cell Therapy System has potential to be the first minimally invasive catheter-based cell therapy available in Japan.

 

 

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 at two clinical sites and three patients have been treated. We are working to complete the roll-in cohort of five patients in the fourth quarter of 2023 and begin the randomized phase of the trial. Strategies of using the cell population analysis as a means to set patient dosing as opposed to excluding patients, and means to include more patients based on modifying baseline exclusion criteria are under consideration to enable more rapid enrollment. Six additional centers are actively being onboarded. 

 

The Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) has designated that both of our CardiAMP pivotal trials qualify for Medicare national coverage at up to $20,000 per patient. The covered costs under Medicare 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 the CMS reimbursement policy and are similarly anticipated to cover these costs. This coverage significantly reduces our cost of conducting these pivotal trials.

 

Allogeneic MSC Cell Therapy Platform

 

Our second therapeutic platform is our investigational culture expanded bone marrow derived allogeneic, Neurokinin-1 Receptor Positive Mesenchymal Stem Cells (NK1R+ MSC) for which the FDA approved two INDs in 2022. This “off the shelf” cell therapy is being advanced for ischemic heart failure of HFrEF (BCDA-03) and acute respiratory distress (BCDA-04). Variations of this allogeneic therapy may have the potential for numerous other therapeutic applications. We manufacture these cells for clinical studies at our manufacturing facility in Sunnyvale which was certified for manufacturing in 2022. Clinical grade cells are available for both indications being pursued today.

 

CardiALLO Allogeneic MSC for Heart Failure

 

In December 2022, the FDA approved our Investigational New Drug (IND) application to initiate a first-in-human Phase I/II 69 patient clinical trial to deliver these allogeneic cells for the treatment of HFrEF (BCDA-03). The trial is designed for patients with New York Heart Association Class II and III ischemic heart failure with ischemic HFrEF whose own cell composition makes them ineligible for the Company’s Phase III CardiAMP® Heart Failure Trial studying autologous cell therapy. Efficiencies are expected in conducting this trial as patients who have been screened but are ineligible for enrollment in the CardiAMP Heart Failure trial would likely be eligible for this allogeneic trial. Clinical grade allogeneic cells have been manufactured and are ready for use and the cells will be delivered by our proprietary delivery system, also manufactured at BioCardia. Our first clinical center has finalized its clinical study agreement and received conditional IRB approval.  Cellular preparation test runs at the clinical site and the site activation visit is scheduled in August and we expect to begin enrolling patients in the third quarter of 2023.

 

This study follows our three previous cosponsored clinical trials with MSCs in ischemic heart failure: the Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT, NCT00768066), the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (POSEIDON, NCT01087996), and the Transendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study (TRIDENT, NCT 02013674). In all three of these trials, with 93 patients treated with culture expanded MSCs using the Helix delivery system, there were no treatment emergent serious adverse events. Results showed compelling early signals for benefit that the CardiALLO trial is expected to build upon.

 

Recently reported large studies using MSC in heart failure by other groups has shown compelling benefits in patients who have evidence of inflammation before receiving treatment. There are active considerations of testing this hypothesis prospectively in the randomized stage of the CardiALLO study ahead.

 

Allogeneic MSC for Respiratory Disease

 

In April 2022, the FDA approved the Company’s Investigational New Drug (IND) for a Phase I/II trial for the use of this allogeneic cell therapy for Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 (BCDA-04). This allogeneic cell therapy trial has been deprioritized to focus current financial resources on other programs.  This decision was based on the greatly reduced population of patients with acute respiratory distress secondary to COVID.   When resources permit, we intend to expand the current indication to a broader ARDS population not requiring COVID as well as pursue other pulmonary indications.

 

Helix™ Biotherapeutic Delivery System

 

BioCardia’s Helix Biotherapeutic Delivery System (Helix) delivers therapeutics into the heart muscle with a penetrating helical needle from within the heart. It enables local delivery of cell and gene-based therapies, including BioCardia’s own cell therapies.  It remains the safest, easiest to use, and most efficient means for the delivery of cells, genes, and proteins to the heart muscle.  The delivery platform includes proprietary approved steerable guide systems, approved delivery catheters, and investigational imaging navigation.

 

Our Helix team has active discussions with current and prospective partners regarding programs utilizing the Helix platform.  We expect to finalize up to two licensing and development relationships later this year.  These relationships are intended to share the costs of ongoing maintenance of and advances in the valuable enabling platform, and for BioCardia shareholders to benefit from the future success of these partnered programs.

 

 

COVID-19 Considerations

 

As a result of the COVID-19 pandemic, we have experienced significant disruption to our business and delays in our development programs and regulatory and commercialization timelines, including adverse impact to our operations at certain clinical sites involved in our ongoing clinical studies. The COVID-19 pandemic could continue to adversely affect our business, results of operations, financial condition and/or liquidity in the future. These adverse impacts could include delayed or slowed enrollment of our, or our collaborators’, planned or ongoing clinical trials, delayed or cancelled clinical site initiations, delayed regulatory review for regulatory approvals, delayed commercialization of one or more of our product candidates, if approved, and workforce shortages. Our production capabilities, or those of our partners or suppliers, and our supply chains could also be adversely impacted.

 

Additionally, while the potential continuing economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of COVID-19 and related responses of governments, business and other institutions on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact our liquidity and ability to raise the capital to complete our preclinical and clinical studies on a timely basis, or at all. In addition, a recession, market correction or depression resulting from the COVID-19 pandemic or the response to it could materially affect our business and the value of our common stock. 

 

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 AVANCE steerable introducer 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 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 autologous cell therapy trials in heart failure and chronic myocardial ischemia, and begin our allogeneic cell therapy trials in heart failure and acute respiratory distress syndrome. 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. There are also significant synergies between these programs.

 

 

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 and cash equivalents. 

 

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 U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities. 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. 

 

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 7 in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 29, 2023, which is incorporated by reference herein. 

 

Results of Operations

 

Comparison of Three and Six Months Ended June 30, 2023 and 2022

 

The following table shows our results of operations for the three and six months ended June 30, 2023 and 2022 (in thousands): 

 

		Three months ended June 30,								Six months ended June 30,
		2023				2022				2023				2022
Revenue:
Net product revenue		$	—			$	—			$	—			$	1
Collaboration agreement revenue			43				974				107				1,033
Total revenue			43				974				107				1,034
Costs and expenses:
Research and development			2,314				2,304				4,698				4,490
Selling, general and administrative			1,181				1,166				2,371				2,367
Total costs and expenses			3,495				3,470				7,069				6,857
Operating loss			(3,452	)			(2,496	)			(6,962	)			(5,823	)
Other income (expense):
Total other income (expense), net			28				(1	)			37				1
Net loss		$	(3,424	)		$	(2,497	)		$	(6,925	)		$	(5,822	)

 

Revenue. Revenue decreased to $43,000 in the three months ended June 30, 2023 as compared to $974,000 in the three months ended June 30, 2022, and decreased to $107,000 in the six months ended June 30, 2023 as compared to $1,034,000 in the six months ended June 30, 2022 primarily due to the timing of revenue from new and existing collaborative partners coupled with the fulfilment of deliverables and completion of collaborative agreements. The amount and timing of collaboration revenues is largely dependent on our partners’ development activities and may be inconsistent and create significant quarter-to-quarter variation in our revenues.

 

Research and Development Expenses. Research and development expenses increased to $2,314,000 in the three months ended June 30, 2023 as compared to $2,304,000 in the three months ended June 30, 2022, and increased to $4,698,000 in the six months ended June 30, 2023 as compared to $4,490,000 in the six months ended June 30, 2022, primarily due to modestly increasing expenses in support of the CardiAMP Heart Failure Trial.

 

 

Selling, General and Administrative Expenses. Selling, general and administrative expenses increased moderately to $1,181,000 in the three months ended June 30, 2023 as compared to $1,166,000 in three months ended June 30, 2022, and to $2,371,000 in the six months ended June 30, 2023 as compared to $2,367,000 in the six months ended June 30, 2022.

 

Liquidity and Capital Resources

 

We have incurred net losses each year since our inception and as of June 30, 2023, we had an accumulated deficit of approximately $147.5 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 June 30, 2023, we had cash and cash equivalents of approximately $4.3 million. 

 

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

 

		Six months ended June 30,
		2023				2022
Net cash provided by (used in):
Operating activities		$	(5,711	)		$	(5,558	)
Investing activities			(12	)			(54	)
Financing activities			2,665				1,354
Net decrease in cash and cash equivalents		$	(3,058	)		$	(4,258	)

 

Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms, and was relatively consistent during the periods presented.

 

Cash Flows from Investing Activities. Net cash used in investing activities of $12,000 and $54,000 during the six months ended June 30, 2023 and 2022, respectively, consisted of purchases of property and equipment, primarily lab and office equipment.

 

Cash Flows from Financing Activities. Net cash provided by financing activities of $2,665,000 and $1,354,000 during the six months ended June 30, 2023 and 2022, respectively related primarily to proceeds from the sale of common stock. 

 

June 2023 Financing - On June 21, 2023, we sold to certain existing investors and other institutional investors, as well as certain directors and officers of the Company (the Purchasers) 1,133,141 shares of our common stock in a registered direct offering (the Offering) at an offering price of $2.336 per share. Certain of the Company’s directors and executive officers purchased an aggregate of 203,337 of such shares. The gross proceeds of the Offering were approximately $2.6 million, with associated issuance costs of approximately $177,000.

 

Cantor Fitzgerald ATM Offering

 

On April 12, 2022, we entered into a sales agreement (Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). We are not obligated to sell any common stock shares pursuant to the Sales Agreement. Under the terms of the Sales Agreement, we pay Cantor a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees. We filed a prospectus supplement under our existing registration statement covering the offer and sale of up to $10.5 million of common stock, of which approximately $8.4 million was still available for offer and sale as of June 30, 2023.

 

During the three and six months ended June 30, 2023, we sold 28,599 and 134,840 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $58,000 and $302,000, with net issuance costs of approximately $29,000 and $42,000, respectively. During both the three and six months ended June 30, 2022, we sold 575,000 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $1.5 million, with net issuance costs of approximately $232,000.

 

 

Lincoln Park Capital Stock Purchase Agreement

 

On March 29, 2021, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park) (Purchase Agreement) and a registration rights agreement (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 in the Purchase Agreement.

 

Pursuant to the Purchase Agreement in March 2021, 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 (Initial Purchase) and we 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.

 

As of June 30, 2023, we had not sold any common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. On June 30, 2023, we provided notice to Lincoln Park of our election to terminate the Purchase Agreement. Following such termination, which was effective July 3, 2023, we may not sell any further shares of our common stock under the Purchase Agreement.

 

Future Funding Requirements

 

To date, we have generated modest revenues. 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.      

 

Based upon our current operating plan, we believe that the cash and cash equivalents of $4.3 million as of June 30, 2023 are not sufficient to fund our planned expenditures and meet our obligations beyond the fourth quarter of 2023. In order to continue development of our therapeutic candidates beyond the fourth quarter of 2023, we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. 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, including the recent determination by the DSMB to pause our CardiAMP Cell Therapy Heart Failure Trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated, 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 autologous CardiAMP Cell Therapy System and allogeneic Neurokinin-1 Receptor Positive clinical trials and related development programs;

 

•

FDA acceptance of our autologous CardiAMP Cell Therapy System and allogeneic Neurokinin-1 Receptor Positive therapies for heart failure and for other potential indications;

 

•

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

 

•

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

 

•

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

 

•

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

 

•

our need to expand our research and development activities;

 

•

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

 

•

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

 

•

the cost of the impact from the COVID-19 pandemic.

 

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.

 

Our condensed consolidated financial statements as of June 30, 2023 have been prepared on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about our ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend, in a large part, on our ability to raise additional capital. If adequate funds are not available, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.

 

The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are unable to continue as a going concern, we may be forced to liquidate assets. In such a scenario, the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed consolidated financial statements. 

 

Off-Balance Sheet Arrangements

 

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

 

Recent Accounting Pronouncements

 

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

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

There have been no material changes in our market risks during the three months ended June 30, 2023.

 

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 June 30, 2023, 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 June 30, 2023, 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 June 30, 2023, 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 June 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

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

 

ITEM 1A. RISK FACTORS

 

In addition to the other information set forth in this report, you should carefully consider the factors discussed below and in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2022, which could materially affect our business, financial condition, or future results, are incorporated by reference herein. The risks described in this report, our Annual Report on Form 10-K for the year ended December 31, 2022, 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 may also materially adversely affect our business, financial condition or future results.

 

Because the CardiAMP Cell Therapy System is, to our knowledge, the first cardiac cell-based therapy with an accepted pivotal trial that is to be regulated by the FDA via the premarket approval pathway, the approval process for the CardiAMP Cell Therapy System is uncertain.

 

Although we have obtained FDA acceptance of Phase III pivotal trials of the CardiAMP Cell Therapy System for the treatment of HFrEF and chronic myocardial ischemia, this does not guarantee any particular outcome from regulatory review. To the best of our knowledge, the CardiAMP Cell Therapy System for the treatment of HFrEF is the first cardiac cell-based therapy with an accepted pivotal trial that is to be regulated by the FDA Center for Biologics Evaluation and Research, or CBER, via the premarket approval, or PMA, pathway requiring a single trial. The CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia is also to be regulated under the same IDE/PMA pathway. All other cardiac cell-based therapies in clinical trials are believed to be regulated by the same agency, but as biologics which generally require two separate pivotal trials. There is no guarantee that the FDA will grant us regulatory clearance or approval to market the CardiAMP Cell Therapy System on the basis of a single pivotal trial, or that the FDA will continue to allow us to develop the CardiAMP Cell Therapy System via the PMA pathway. Two well-controlled pivotal studies could be necessary to provide FDA assurance of safety or effectiveness. If the FDA approval process does not occur as we anticipate or we are required to conduct more than one pivotal study to obtain approval, we may incur substantial additional costs and delays to obtain approval, if at all, which would have a material adverse impact on our business, financial condition and prospects. For example, in July 2023, DSMB completed its prespecified review for the ongoing Phase III pivotal CardiAMP Cell Therapy Trial and recommended that the trial enrollment be paused, pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated. The DSMB recommended the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after the completion of the one-year data analysis.  This delay may cause substantial additional costs and delays to obtain approval, if at all, which would have a material adverse impact on our business, financial condition and prospects.

 

We have encountered, and may in the future encounter, substantial delays in our clinical studies.

 

We have encountered, and may in the future encounter, substantial delays in our clinical studies. We cannot guarantee that any preclinical testing or clinical trials will be conducted as planned or completed on schedule, if at all. As a result, we may not achieve our expected clinical milestones. A failure can occur at any stage of testing. Events that may prevent successful or timely commencement, enrollment or completion of clinical development include:

 

●

delays in raising, or inability to raise, sufficient capital to fund the planned trials;

●

delays in reaching a consensus with regulatory agencies on trial design;

●

changes in trial design;

●

inability to identify, recruit and train suitable clinical investigators;

●

inability to add new clinical trial sites;

●

delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations, or CROs, and clinical trial sites;

●

delays in obtaining required Institutional Review Board, or IRB, approval at each clinical trial site;

●

delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials;

●

imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites;

●

failure by us, CROs or other third parties to adhere to clinical trial requirements;

●

failure to perform in accordance with the FDA’s current Good Clinical Practices, or GCP, or applicable regulatory guidelines in other countries;

●

delays in the testing, validation, manufacturing and delivery to the clinical sites;

●

delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;

●

delays caused by clinical trial sites not completing a trial;

●

failure to demonstrate adequate efficacy;

●

occurrence of serious adverse events in clinical trials that are associated with the therapeutic candidates or products that are viewed to outweigh its potential benefits;

●

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; or

●

disagreements between us and the FDA or other regulatory agencies interpreting the data from our clinical trials, including the determination from the DSMB to recommend pausing our Phase III pivotal CardiAMP Cell Therapy Trial pending the one-year follow-up outcomes analysis.

 

 

Delays, including those caused by the above factors, can be costly and could negatively affect our ability to complete clinical trials for our therapeutic candidates. If we are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval and/or will not be able to commercialize our therapeutic candidates or products, which would have an adverse effect on our business. Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our therapeutic candidates or products or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our therapeutic candidates or products and may harm our business and results of operations.

 

We are delinquent in holding our annual meeting of stockholders under Delaware law.

 

Under the Delaware General Corporation Law, our annual meeting must be held within 13 months of our last annual meeting. As such, we were required to hold our 2023 Annual Meeting of Stockholders by July 10, 2023 and are not in compliance with this requirement under Delaware law. While our board is taking steps to schedule and hold our annual meeting, we are at risk of potential stockholder litigation until such meeting occurs, which may be adverse to our business and avert management’s attention from operating the business.

 

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

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

ITEM 6. EXHIBIT INDEX

 

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, as amended April 30, 2023
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+	Inline XBRL Instance Document
101.SCH+	Inline XBRL Taxonomy Extension Schema Document
101.CAL+	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF+	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB+	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE+	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

*	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 3.1 to the Current Report on Form 8-K filed by us on April 30, 2023.

 

 

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:                        August 9, 2023	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)
Date:                        August 9, 2023	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

 

 

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:                           August 9, 2023

	/s/ Peter Altman
	Name: Peter Altman
	Title: President and Chief Executive Officer (Principal Executive Officer)

 

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:                         August 9, 2023

	/s/ David McClung
	Name: David McClung
	Title: Chief Financial Officer (Principal Financial Officer)

 

 

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 June 30, 2023 (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:                       August 9, 2023

	/s/ Peter Altman
	Name: Peter Altman
	Title: President and Chief Executive Officer (Principal Executive Officer)

 

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 June 30, 2023 (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:                         August 9, 2023

	/s/ David McClung
	Name: David McClung
	Title: Chief Financial Officer (Principal Financial Officer)

 

 

 

 

v3.23.2

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2023	Jul. 31, 2023
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	0-21419
Entity Registrant Name	BioCardia, Inc
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	23-2753988
Entity Address, Address Line One	320 Soquel Way
Entity Address, City or Town	Sunnyvale
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94085
City Area Code	650
Local Phone Number	226-0120
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding (in shares)		21,619,432
Entity Central Index Key	0000925741
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	BCDA
Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrant to Purchase Common Stock
Trading Symbol	BCDAW
Security Exchange Name	NASDAQ

v3.23.2

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 4,305,000	$ 7,363,000
Accounts receivable, net of allowance for doubtful accounts of $11 as of both June 30, 2023 and December 31, 2022	115,000	201,000
Prepaid expenses and other current assets	230,000	300,000
Total current assets	4,650,000	7,864,000
Property and equipment, net	139,000	170,000
Operating lease right-of-use asset, net	1,429,000	1,588,000
Other assets	171,000	171,000
Total assets	6,389,000	9,793,000
Current liabilities:
Accounts payable	686,000	683,000
Accrued expenses and other current liabilities	2,257,000	2,246,000
Deferred revenue	333,000	341,000
Operating lease liability - current	340,000	315,000
Total current liabilities	3,616,000	3,585,000
Operating lease liability - noncurrent	1,138,000	1,316,000
Total liabilities	4,754,000	4,901,000
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of June 30, 2023 and December 31, 2022	0	0
Common stock, $0.001 par value, 100,000,000 shares authorized, 21,586,150 and 20,076,773 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	22,000	20,000
Additional paid-in capital	149,142,000	145,476,000
Accumulated deficit	(147,529,000)	(140,604,000)
Total stockholders’ equity	1,635,000	4,892,000
Total liabilities and stockholders’ equity	$ 6,389,000	$ 9,793,000

v3.23.2

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022
Accounts Receivable, Allowance for Credit Loss, Current	$ 11		$ 11
Preferred Stock, Par or Stated Value Per Share (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 or Stated Value Per Share (in dollars per share)		$ 0.001	$ 0.001
Common Stock, Shares Authorized (in shares)	100,000,000		100,000,000
Common Stock, Shares, Outstanding (in shares)	21,586,150		20,076,773
Common Stock, Shares, Issued (in shares)	21,586,150		20,076,773

v3.23.2

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Revenue:
Net product revenue	$ 43	$ 974	$ 107	$ 1,034
Costs and expenses:
Research and development	2,314	2,304	4,698	4,490
Selling, general and administrative	1,181	1,166	2,371	2,367
Total costs and expenses	3,495	3,470	7,069	6,857
Operating loss	(3,452)	(2,496)	(6,962)	(5,823)
Other income (expense):
Total other income, net	28	(1)	37	1
Net loss	$ (3,424)	$ (2,497)	$ (6,925)	$ (5,822)
Net loss per share, basic and diluted (in dollars per share)	$ (0.17)	$ (0.14)	$ (0.34)	$ (0.34)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	20,384,522	17,651,892	20,281,417	17,360,598
Product [Member]
Revenue:
Net product revenue	$ 0	$ 0	$ 0	$ 1
Collaboration Agreement [Member]
Revenue:
Net product revenue	$ 43	$ 974	$ 107	$ 1,033

v3.23.2

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member] Management [Member] Restricted Stock Units (RSUs) [Member]	Common Stock [Member] ATM [Member]	Common Stock [Member]	Additional Paid-in Capital [Member] Management [Member] Restricted Stock Units (RSUs) [Member]	Additional Paid-in Capital [Member] ATM [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member] Management [Member] Restricted Stock Units (RSUs) [Member]	Retained Earnings [Member] ATM [Member]	Retained Earnings [Member]	Management [Member] Restricted Stock Units (RSUs) [Member]	ATM [Member]	Total
Balance (in shares) at Dec. 31, 2021			16,871,265
Balance at Dec. 31, 2021			$ 17,000			$ 139,055,000			$ (128,697,000)			$ 10,375,000
Share-based compensation						319,000						319,000
Net loss									(3,325,000)			(3,325,000)
Share-based compensation						319,000						319,000
Balance (in shares) at Mar. 31, 2022			16,871,265
Balance at Mar. 31, 2022			$ 17,000			139,374,000			(132,022,000)			7,369,000
Balance (in shares) at Dec. 31, 2021			16,871,265
Balance at Dec. 31, 2021			$ 17,000			139,055,000			(128,697,000)			10,375,000
Net loss												(5,822,000)
Balance (in shares) at Jun. 30, 2022			17,758,194,000
Balance at Jun. 30, 2022			$ 18,000			141,235,000			(134,519,000)			6,734
Balance (in shares) at Mar. 31, 2022			16,871,265
Balance at Mar. 31, 2022			$ 17,000			139,374,000			(132,022,000)			7,369,000
Share-based compensation			0			304,000			0			304,000
Net loss			$ 0			0			(2,497,000)			(2,497,000)
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)			311,929
Restricted stock units issued to settle management bonus obligations	$ 0			$ 271,000			$ 0			$ 271,000
Sale of common stock, net of issuance costs (in shares)		575,000
Sale of common stock, net of issuance costs		$ 1,000			$ 1,286,000			$ 0			$ 1,287,000
Share-based compensation			$ 0			304,000			0			304,000
Restricted stock units vested and issued (in shares)			311,929
Balance (in shares) at Jun. 30, 2022			17,758,194,000
Balance at Jun. 30, 2022			$ 18,000			141,235,000			(134,519,000)			6,734
Balance (in shares) at Dec. 31, 2022			20,076,773
Balance at Dec. 31, 2022			$ 20,000			145,476,000			(140,604,000)			4,892,000
Share-based compensation			0			278,000			0			278,000
Net loss			$ 0			0			(3,501,000)			(3,501,000)
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)			18,792
Sale of common stock, net of issuance costs (in shares)		106,241
Sale of common stock, net of issuance costs		$ 0			231,000			0			231,000
Share-based compensation			$ 0			278,000			0			278,000
Exercise of common stock options (in shares)			199
Exercise of common stock options						0						0
Restricted stock units vested and issued (in shares)			18,792
Balance (in shares) at Mar. 31, 2023			20,202,005
Balance at Mar. 31, 2023			$ 20,000			145,985,000			(144,105,000)			1,900,000
Balance (in shares) at Dec. 31, 2022			20,076,773
Balance at Dec. 31, 2022			$ 20,000			145,476,000			(140,604,000)			4,892,000
Net loss												$ (6,925,000)
Exercise of common stock options (in shares)												199
Balance (in shares) at Jun. 30, 2023			21,586,150
Balance at Jun. 30, 2023			$ 22,000			149,142,000			(147,529,000)			$ 1,635,000
Balance (in shares) at Mar. 31, 2023			20,202,005
Balance at Mar. 31, 2023			$ 20,000			145,985,000			(144,105,000)			1,900,000
Share-based compensation						317,000						317,000
Net loss									(3,424,000)			(3,424,000)
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)			222,405,000
Restricted stock units issued to settle management bonus obligations	$ 0			$ 342,000			$ 0			$ 342,000
Sale of common stock, net of issuance costs (in shares)		28,599	1,133,141
Sale of common stock, net of issuance costs		$ 0	$ 1,000		$ 29,000	2,469,000		$ 0	0		$ 29,000	2,470,000
Share-based compensation						317,000						317,000
Restricted stock units vested and issued (in shares)			222,405,000
Restricted stock units vested and issued			$ 1,000			0			0			1,000
Balance (in shares) at Jun. 30, 2023			21,586,150
Balance at Jun. 30, 2023			$ 22,000			$ 149,142,000			$ (147,529,000)			$ 1,635,000

v3.23.2

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parentheticals) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022
ATM [Member]
Issuance costs	$ 29	$ 13
Issuance costs	$ 177		$ 232

v3.23.2

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Operating activities:
Net loss	$ (6,925)	$ (5,822)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	43	32
Reduction in the carrying amount of right-of-use assets	159	144
Share-based compensation	595	623
Changes in operating assets and liabilities:
Accounts receivable	86	(64)
Prepaid expenses and other current assets	70	136
Accounts payable	69	425
Accrued expenses and other current liabilities	353	(87)
Deferred revenue	(8)	(847)
Operating lease liability	(153)	(98)
Net cash used in operating activities	(5,711)	(5,558)
Investing activities:
Purchase of property and equipment	(12)	(54)
Net cash used in investing activities	(12)	(54)
Financing activities:
Proceeds from sales of common stock	2,950	1,519
Issuance costs of sale of common stock	(285)	(165)
Net cash provided by financing activities	2,665	1,354
Net change in cash and cash equivalents	(3,058)	(4,258)
Cash and cash equivalents at beginning of period	7,363	12,872
Cash and cash equivalents at end of period	4,305	8,614
Supplemental disclosure of noncash investing and financing activities:
Unpaid issuance costs of common stock	106	67
Issuance of restricted stock units in lieu of cash bonus obligations	$ 564	$ 401

v3.23.2

Note 1 - Summary of Business and Basis of Presentation	6 Months Ended
	Jun. 30, 2023
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 company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our neurokinin-1 receptor positive (NK1R+) allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS). Our autologous CardiAMP and our allogeneic NK1R+ cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property.           We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.

v3.23.2

Note 2 - Significant Accounting Policies	6 Months Ended
	Jun. 30, 2023
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 June 30, 2023, and for the three and six months ended June 30, 2023 and 2022 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 June 30, 2023, results of operations for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ended December 31, 2023 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 our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 29, 2023.     (b) Liquidity – Going Concern           We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $147.5 million as of June 30, 2023. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $4.3 million as of June 30, 2023 are not sufficient to fund the Company’s planned expenditures and meet its obligations beyond the fourth quarter of 2023. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.   Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond the fourth quarter of 2023 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. If adequate funds are not available, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, or cease operations.     (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, clinical accruals 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, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.     (e) Concentration of Credit Risk           Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On June 30, 2023, approximately 99% of our cash was held by one financial institution and total amounts on deposit were approximately $4.0 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.   Silicon Valley Bank (SVB) was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. On March 12, 2023, a joint statement was issued by the Secretary of the Treasury and the Federal Reserve and the FDIC Chairman stating that all depositors would be fully protected and would have access to both insured and uninsured deposits starting March 12, 2203. The FDIC then established a bridge bank successor, Silicon Valley Bridge Bank, N.A., which quickly assumed ongoing business. On March 27, 2023, First Citizens Bank & Trust Company, a subsidiary of First Citizens BancShares, assumed all customer deposits and acquired all loans of Silicon Valley Bridge Bank from the FDIC and began operating all SVB branches. As of March 31, 2023, the Company transferred substantially all of its cash and cash equivalents from SVB to another financial institution and does not believe it will be impacted by the transition of SVB to First Citizens Bank & Trust Company.     (f) Changes to Significant Accounting Policies           Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed March 29, 2023. There have been no changes to those policies.     (g) 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 our financial statement presentation or disclosures.

v3.23.2

Note 3 - Fair Value Measurement	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Fair Value Disclosures [Text Block]	(3) Fair Value Measurement       The fair value of financial instruments reflects the amounts that we estimate 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). We follow a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:       Level 1 – quoted prices in active markets for identical assets and liabilities.       Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.       Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.       The following table sets forth the fair value of our financial assets measured on a recurring basis and indicates the fair value hierarchy utilized to determine such fair value (in thousands):       As of June 30, 2023                                         Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 20     $ —     $ —     $ 20   Cash in savings account     —       —       —       3,886   Cash in checking account     —       —       —       399   Total cash and cash equivalents   $ 20     $ —     $ —     $ 4,305         As of December 31, 2022       Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 6,893     $ —     $ —     $ 6,893   Cash in checking account     —       —       —       470   Total cash and cash equivalents   $ 6,893     $ —     $ —     $ 7,363

v3.23.2

Note 4 - Property and Equipment, Net	6 Months Ended
	Jun. 30, 2023
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):       June 30,     December 31,       2023     2022   Computer equipment and software   $ 174     $ 161   Laboratory and manufacturing equipment     574       575   Furniture and fixtures     27       27   Leasehold improvements     26       26   Property and equipment, gross     801       789   Less accumulated depreciation     (662 )     (619 ) Property and equipment, net   $ 139     $ 170         Depreciation expense totaled $21,000 and $43,000 for the three and six months ended June 30, 2023, respectively. Depreciation expense totaled $16,000 and $32,000 for the three and six months ended June 30, 2022, respectively.

v3.23.2

Note 5 - Operating Lease Right-of-use Asset, Net	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Lessee, Operating Leases [Text Block]	(5) Operating Lease Right-of-Use Asset, Net       In December 2021, we entered into a lease related to a property lease for our laboratory and corporate offices, which expires in January 2027, with an option for us to extend a further 36 months after expiration. Our lease agreements do not contain any material residual guarantees or material restrictive covenants. We determine 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. We 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. We have no finance leases.       Our lease expense was $120,000 and $241,000 for the three and six months ended June 30, 2023, respectively. Our lease expense for the three and six months ended June 30, 2022 was $120,000 and $241,000, respectively. The cash paid under the operating lease for base rent for the three and six months ended June 30, 2023 was $118,000 and $236,000, respectively. The cash paid under the operating lease for base rent for the three and six months ended June 30, 2022 was $76,000 and $173,000, respectively. On June 30, 2023, the weighted average remaining lease term was 3.59 years, and the weighted average discount rate was 10.74%.       Future minimum lease payments under the operating lease as of June 30, 2023 were as follows (in thousands):   Remainder of 2023   $ 236   2024     485   2025     499   2026     514   2027     44   Total undiscounted lease payments   $ 1,778   Less imputed interest     300   Total operating lease liabilities   $ 1,478

v3.23.2

Note 6 - Accrued Expenses and Other Current Liabilities	6 Months Ended
	Jun. 30, 2023
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):       June 30,     December 31,       2023     2022   Accrued expenses   $ 111     $ 157   Accrued salaries and employee benefits     715       899   Accrued clinical trial costs     821       548   Grant liability     501       534   Customer deposits     90       90   Payable to related party     19       18   Total   $ 2,257     $ 2,246

v3.23.2

Note 7 - Stockholders' Equity	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Equity [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 as of December 31, 2022     2,424,724     $ 6.36   Warrants for common stock sold     —       —   Warrants for common stock exercised     —       —   Balance as of June 30, 2023     2,424,724     $ 6.36     June 2023 Financing - On June 21, 2023, we sold to certain existing investors and other institutional investors, as well as certain directors and officers of the Company (the Purchasers) 1,133,141 shares of our common stock in a registered direct offering (the Offering) at an offering price of $2.336 per share. Certain of the Company’s directors and executive officers purchased an aggregate of 203,337 of such shares. The gross proceeds of the Offering were approximately $2.6 million, with associated issuance costs of approximately $177,000.   Cantor Fitzgerald Sales agreement - On April 12, 2022, we entered into a sales agreement (Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). We are not obligated to sell any common stock shares pursuant to the Sales Agreement. Under the terms of the Sales Agreement, we pay Cantor a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees. We filed a prospectus supplement under our existing registration statement covering the offer and sale of up to $10.5 million of common stock, of which approximately $8.4 million was still available for offer and sale as of June 30, 2023.   During the three and six months ended June 30, 2023, we sold 28,599 and 134,840 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $58,000 and $302,000, with net issuance costs of approximately $29,000 and $42,000, respectively. During both the three and six months ended June 30, 2022, we sold 575,000 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $1.5 million, with net issuance costs of approximately $232,000.   Lincoln Park Capital stock purchase agreement - On March 29, 2021, we entered into a purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park) (Purchase Agreement) and a registration rights agreement (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 in the Purchase Agreement.   Pursuant to the Purchase Agreement in March 2021, 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 (Initial Purchase) and we 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.   As of June 30, 2023, we had not sold any common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. On June 30, 2023, we provided notice to Lincoln Park of our election to terminate the Purchase Agreement. Following such termination, which was effective July 3, 2023, we may not sell any further shares of our common stock under the Purchase Agreement.

v3.23.2

Note 8 - Share-based Compensation	6 Months Ended
	Jun. 30, 2023
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 and six months ended June 30, 2023 and 2022 was recorded as follows (in thousands):       Three months ended     Six months ended       June 30,     June 30,       2023     2022     2023     2022   Research and development   $ 134     $ 130     $ 273     $ 257   Selling, general and administrative     183       174       322       366   Total share-based compensation   $ 317     $ 304     $ 595     $ 623     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 intrinsic value (in thousands)                                     Balance, December 31, 2022     2,182,708     $ 4.04       7.5     $ 343   Stock options granted     543,513       1.69                   Stock options exercised     (199 )     1.49                   Stock options forfeited     (119,941 )     2.36                   Balance, June 30, 2023     2,606,081     $ 3.63       7.3     $ 1,189   Exercisable, June 30, 2023     1,443,515     $ 4.83       6.0     $ 315     Unrecognized share-based compensation for employee and nonemployee options granted through June 30, 2023 is approximately $2.1 million to be recognized over a remaining weighted average service period of 2.7 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, 2022     21,526     $ 4.33   RSUs granted     331,552       1.70   RSUs released     (241,197 )     1.93   RSUs forfeited     (111,881 )     1.70   Balance, June 30, 2023     —     $ n/a     RSUs vested and settled are converted into our common stock on a one-for-one basis. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The related compensation expense, which is based on the grant date fair value of our common stock multiplied by the number of units granted, is recognized ratably over the period during which the vesting restrictions lapse. Unrecognized share-based compensation for employee and nonemployee RSUs granted through June 30, 2023 was $0.

v3.23.2

Note 9 - Net Loss Per Share	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Earnings Per Share [Text Block]	(9) Net Loss per Share   Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. 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 the 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:       June 30,       2023     2022                     Stock options to purchase common stock     2,606,081       2,060,836   Unvested restricted stock units     —       2,734   Common stock warrants     2,424,724       2,424,724   Total     5,030,805       4,488,294

v3.23.2

Note 10 - Income Taxes	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Income Tax Disclosure [Text Block]	(10) Income Taxes   During the three and six months ended June 30, 2023 and 2022, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to our net loss and a full valuation allowance on the resulting deferred tax assets.   As of June 30, 2023, we retain a full valuation allowance on our deferred tax assets in all jurisdictions. The realization of our deferred tax assets depends primarily on our ability to generate future taxable income which is uncertain. We do not believe that our 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.

v3.23.2

Note 11 - Related Party Transactions	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	(11) Related Party Transactions   On April 9, 2020, we entered into a Litigation Funding Agreement (Funding Agreement) with BSLF, L.L.C. (Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding our 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). On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement and all claims were dismissed.   In March 2022, we entered into settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude on all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the confidential agreements, litigation and corporate counsel provided credits and refunds of legal fees totaling $688,000, which offset the amounts owed to us by the Funder under the Funding Agreement, and provided up to $300,000 in future discounts on legal services. As a result of the Litigation Funding Settlement, we will remit the discounts, as received, to the Funder on a quarterly basis. During the three and six months ended June 30, 2023, we received discounts totaling $20,000 and $53,000, respectively. During the three and six months ended June 30, 2022, we received discounts totaling $43,000 and $47,000, respectively. As of June 30, 2023 and December 31, 2022, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $19,000 and $18,000, respectively. As of June 30, 2023, up to $168,455 future potential discounts are due to the Funder.

v3.23.2

Note 12 - Contingencies and Uncertainties	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Contingencies Disclosure [Text Block]	(12) Contingencies and Uncertainties   Contingencies - We 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 our business, financial position, results of operations, or cash flows.   Uncertainties - The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future year, particularly in light of COVID-19 and its impact on domestic and global economies. Governmental and business reactions to the pandemic, and resulting economic disruptions, have the potential to materially impact our business and influence our business decisions. While the impact of COVID-19 did not have a material adverse effect on our financial position or results of operations for the periods presented, our future assessment of the magnitude and duration of COVID-19 and related factors, could result in material impacts to our financial statements in future reporting periods. As of June 30, 2023, up to $168,455 future potential discounts are due to the Funder.

v3.23.2

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2023
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 June 30, 2023, and for the three and six months ended June 30, 2023 and 2022 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 June 30, 2023, results of operations for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ended December 31, 2023 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 our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 29, 2023.
Going Concern and Liquidity [Policy Text Block]	(b) Liquidity – Going Concern           We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $147.5 million as of June 30, 2023. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $4.3 million as of June 30, 2023 are not sufficient to fund the Company’s planned expenditures and meet its obligations beyond the fourth quarter of 2023. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.   Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond the fourth quarter of 2023 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. If adequate funds are not available, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, or cease operations.
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, clinical accruals 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, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.
Concentration Risk, Credit Risk, Policy [Policy Text Block]	(e) Concentration of Credit Risk           Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On June 30, 2023, approximately 99% of our cash was held by one financial institution and total amounts on deposit were approximately $4.0 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.   Silicon Valley Bank (SVB) was closed on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. On March 12, 2023, a joint statement was issued by the Secretary of the Treasury and the Federal Reserve and the FDIC Chairman stating that all depositors would be fully protected and would have access to both insured and uninsured deposits starting March 12, 2203. The FDIC then established a bridge bank successor, Silicon Valley Bridge Bank, N.A., which quickly assumed ongoing business. On March 27, 2023, First Citizens Bank & Trust Company, a subsidiary of First Citizens BancShares, assumed all customer deposits and acquired all loans of Silicon Valley Bridge Bank from the FDIC and began operating all SVB branches. As of March 31, 2023, the Company transferred substantially all of its cash and cash equivalents from SVB to another financial institution and does not believe it will be impacted by the transition of SVB to First Citizens Bank & Trust Company.
Change to Significant Accounting Policies [Policy Text Block]	(f) Changes to Significant Accounting Policies           Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed March 29, 2023. There have been no changes to those policies.
New Accounting Pronouncements, Policy [Policy Text Block]	(g) 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 our financial statement presentation or disclosures.

v3.23.2

Note 3 - Fair Value Measurement (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]	As of June 30, 2023                                         Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 20     $ —     $ —     $ 20   Cash in savings account     —       —       —       3,886   Cash in checking account     —       —       —       399   Total cash and cash equivalents   $ 20     $ —     $ —     $ 4,305       As of December 31, 2022       Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 6,893     $ —     $ —     $ 6,893   Cash in checking account     —       —       —       470   Total cash and cash equivalents   $ 6,893     $ —     $ —     $ 7,363

v3.23.2

Note 4 - Property and Equipment, Net (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Property, Plant and Equipment [Table Text Block]	June 30,     December 31,       2023     2022   Computer equipment and software   $ 174     $ 161   Laboratory and manufacturing equipment     574       575   Furniture and fixtures     27       27   Leasehold improvements     26       26   Property and equipment, gross     801       789   Less accumulated depreciation     (662 )     (619 ) Property and equipment, net   $ 139     $ 170

v3.23.2

Note 5 - Operating Lease Right-of-use Asset, Net (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]	Remainder of 2023   $ 236   2024     485   2025     499   2026     514   2027     44   Total undiscounted lease payments   $ 1,778   Less imputed interest     300   Total operating lease liabilities   $ 1,478

v3.23.2

Note 6 - Accrued Expenses and Other Current Liabilities (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block]	June 30,     December 31,       2023     2022   Accrued expenses   $ 111     $ 157   Accrued salaries and employee benefits     715       899   Accrued clinical trial costs     821       548   Grant liability     501       534   Customer deposits     90       90   Payable to related party     19       18   Total   $ 2,257     $ 2,246

v3.23.2

Note 7 - Stockholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]	Number of     Weighted       Common Stock     Average       Warrants     Exercise Price   Balance as of December 31, 2022     2,424,724     $ 6.36   Warrants for common stock sold     —       —   Warrants for common stock exercised     —       —   Balance as of June 30, 2023     2,424,724     $ 6.36

v3.23.2

Note 8 - Share-based Compensation (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Share-based Compensation, Expense [Table Text Block]	Three months ended     Six months ended       June 30,     June 30,       2023     2022     2023     2022   Research and development   $ 134     $ 130     $ 273     $ 257   Selling, general and administrative     183       174       322       366   Total share-based compensation   $ 317     $ 304     $ 595     $ 623
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 intrinsic value (in thousands)                                     Balance, December 31, 2022     2,182,708     $ 4.04       7.5     $ 343   Stock options granted     543,513       1.69                   Stock options exercised     (199 )     1.49                   Stock options forfeited     (119,941 )     2.36                   Balance, June 30, 2023     2,606,081     $ 3.63       7.3     $ 1,189   Exercisable, June 30, 2023     1,443,515     $ 4.83       6.0     $ 315
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]	Weighted               average               grant date       Number of     fair value       shares     per share   Balance, December 31, 2022     21,526     $ 4.33   RSUs granted     331,552       1.70   RSUs released     (241,197 )     1.93   RSUs forfeited     (111,881 )     1.70   Balance, June 30, 2023     —     $ n/a

v3.23.2

Note 9 - Net Loss Per Share (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	June 30,       2023     2022                     Stock options to purchase common stock     2,606,081       2,060,836   Unvested restricted stock units     —       2,734   Common stock warrants     2,424,724       2,424,724   Total     5,030,805       4,488,294

v3.23.2

Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Retained Earnings (Accumulated Deficit), Total	$ (147,529)	$ (140,604)
Cash and Cash Equivalents, at Carrying Value, Total	$ 4,305	$ 7,363
Cash, Percentage Held in One Financial Institution	99.00%
Cash, Uninsured Amount	$ 4,000

v3.23.2

Note 3 - Fair Value Measurement - Fair Value of Assets Measured on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Money market funds	$ 4,305	$ 7,363
Fair Value, Inputs, Level 1 [Member]
Money market funds	20	6,893
Fair Value, Inputs, Level 2 [Member]
Money market funds	0	0
Fair Value, Inputs, Level 3 [Member]
Money market funds	0	0
Money Market Funds [Member]
Money market funds	20	6,893
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member]
Money market funds	20	6,893
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member]
Money market funds	0	0
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member]
Money market funds	0	0
Demand Deposits [Member]
Money market funds	399	45
Demand Deposits [Member] | Fair Value, Inputs, Level 1 [Member]
Money market funds	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 2 [Member]
Money market funds	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 3 [Member]
Money market funds	0	$ 0
Savings Account [Member]
Money market funds	3,886
Savings Account [Member] | Fair Value, Inputs, Level 1 [Member]
Money market funds	0
Savings Account [Member] | Fair Value, Inputs, Level 2 [Member]
Money market funds	0
Savings Account [Member] | Fair Value, Inputs, Level 3 [Member]
Money market funds	$ 0

v3.23.2

Note 4 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Depreciation	$ 16,000	$ 21,000	$ 32,000	$ 43,000

v3.23.2

Note 4 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Computer equipment and software	$ 801	$ 789
Less accumulated depreciation	(662)	(619)
Property and equipment, net	139	170
Computer Equipment and Software [Member]
Computer equipment and software	174	161
Laboratory and Manufacturing Equipment [Member]
Computer equipment and software	574	575
Furniture and Fixtures [Member]
Computer equipment and software	27	27
Leasehold Improvements [Member]
Computer equipment and software	$ 26	$ 26

v3.23.2

Note 5 - Operating Lease Right-of-use Asset, Net (Details Textual) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating Lease, Expense	$ 120,000	$ 120,000	$ 241,000	$ 241,000
Operating Lease, Payments	$ 118,000	$ 76,000	$ 236,000	$ 173,000
Operating Lease, Weighted Average Remaining Lease Term	3 years 7 months 2 days		3 years 7 months 2 days
Operating Lease, Weighted Average Discount Rate, Percent	10.74%		10.74%

v3.23.2

Note 5 - Operating Lease Right-of-use Asset, Net - Future Minimum Lease Payments Under Operating Lease (Details) $ in Thousands	Jun. 30, 2023 USD ($)
Remainder of 2023	$ 236
2024	485
2025	499
2026	514
2027	44
Total undiscounted lease payments	1,778
Less imputed interest	300
Total operating lease liabilities	$ 1,478

v3.23.2

Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Accrued expenses	$ 111	$ 157
Accrued salaries and employee benefits	715	899
Accrued clinical trial costs	821	548
Grant liability	501	534
Customer deposits	90	90
Total	2,257	2,246
Related Party [Member]
Payable to related party	$ 19	$ 18

v3.23.2

Note 7 - Stockholders' Equity (Details Textual) - USD ($)					3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 21, 2023	Apr. 12, 2022	Mar. 29, 2021	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Proceeds from Issuance of Common Stock							$ 2,950,000	$ 1,519,000
Payments of Stock Issuance Costs							$ 285,000	$ 165,000
Underwriters [Member]
Stock Issued During Period, Shares, New Issues (in shares)				80,000
June 2023 Financing [Member]
Stock Issued During Period, Shares, New Issues (in shares)		1,133,141
Shares Issued, Price Per Share (in dollars per share)		$ 2.336
Proceeds from Issuance of Common Stock		$ 2,600,000
Payments of Stock Issuance Costs		$ 177,000
June 2023 Financing [Member] | Company’s Directors and Executive Officers [Member]
Stock Issued During Period, Shares, New Issues (in shares)		203,337
Sales Agreement with Cantor Fitzgerald Co (Cantor) [Member]
Stock Issued During Period, Shares, New Issues (in shares)					28,599	575,000	134,840
Proceeds from Issuance of Common Stock					$ 58,000	$ 1,500,000	$ 302,000
Payments of Stock Issuance Costs					$ 29,000	$ 232,000	$ 42,000
Sale of Stock, Aggregate Value, Maximum	$ 8,400,000		$ 10,500,000
Accrued Sales Commission, Current, Percentage			3.00%
Purchase Agreement with Lincoln Park [Member]
Stock Issued During Period, Shares, New Issues (in shares)				373,832
Shares Issued, Price Per Share (in dollars per share)				$ 5.35
Proceeds from Issuance of Common Stock				$ 2,000,000
Sale of Stock, Aggregate Value, Maximum				$ 20,000,000
Stock Issuable, Commitment Shares on Pro Rata Basis				5,000

v3.23.2

Note 7 - Stockholders' Equity - Warrants (Details)	6 Months Ended
	Jun. 30, 2023 $ / shares shares
Balance , number of common stock warrants (in shares) | shares	2,424,724
Balance, weighted average exercise price (in dollars per share) | $ / shares	$ 6.36
Warrants for common stock sold , number of common stock warrants (in shares) | shares	0
Warrants for common stock sold, weighted average exercise price (in dollars per share) | $ / shares	$ 0
Warrants for common stock exercised , number of common stock warrants (in shares) | shares	0
Warrants for common stock exercised, weighted average exercise price (in dollars per share) | $ / shares	$ 0
Balance , number of common stock warrants (in shares) | shares	2,424,724
Balance as, weighted average exercise price (in dollars per share) | $ / shares	$ 6.36

v3.23.2

Note 8 - Share-based Compensation (Details Textual) $ in Thousands	6 Months Ended
	Jun. 30, 2023 USD ($)
Restricted Stock Units (RSUs) [Member]
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount	$ 0
Employees, Non-employees and Non-employee Directors [Member]
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount	$ 2,100
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition	2 years 8 months 12 days

v3.23.2

Note 8 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Total share-based compensation	$ 317	$ 304	$ 595	$ 623
Research and Development Expense [Member]
Total share-based compensation	134	130	273	257
Selling, General and Administrative Expenses [Member]
Total share-based compensation	$ 183	$ 174	$ 322	$ 366

v3.23.2

Note 8 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Balance, number of shares (in shares)	2,182,708
Balance, weighted average exercise price (in dollars per share)	$ 4.04
Balance, weighted average remaining contractual term (Year)	7 years 3 months 18 days	7 years 6 months
Balance, aggregate intrinsic value	$ 1,189	$ 343
Stock options granted, number of shares (in shares)	543,513
Stock options granted, weighted average exercise price (in dollars per share)	$ 1.69
Stock options exercised, number of shares (in shares)	(199)
Stock options exercised, weighted average exercise price (in dollars per share)	$ 1.49
Stock options forfeited, number of shares (in shares)	(119,941)
Stock options forfeited, weighted average exercise price (in dollars per share)	$ 2.36
Balance, number of shares (in shares)	2,606,081	2,182,708
Balance, weighted average exercise price (in dollars per share)	$ 3.63	$ 4.04
Exercisable, number of shares (in shares)	1,443,515
Exercisable, weighted average exercise price (in dollars per share)	$ 4.83
Exercisable, weighted average remaining contractual term (Year)	6 years
Exercisable, aggregate intrinsic value	$ 315

v3.23.2

Note 9 - Share-based Compensation - Summary of Non-vested RSUs (Details) - $ / shares	6 Months Ended
	Jun. 30, 2023	Jan. 01, 2023
RSUs granted, weighted average grant date fair value per share (in dollars per share)	$ 1.70
RSUs released, weighted average grant date fair value per share (in dollars per share)	1.93
RSUs forfeited, weighted average grant date fair value per share (in dollars per share)	$ 1.70
Restricted Stock Units (RSUs) [Member]
Balance, number of shares (in shares)	21,526
Balance, weighted average grant date fair value per share (in dollars per share)		$ 4.33
RSUs granted, number of shares (in shares)	331,552
RSUs released, number of shares (in shares)	(241,197)
RSUs forfeited, number of shares (in shares)	(111,881)
Balance, number of shares (in shares)	0

v3.23.2

Note 9 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Antidilutive securities (in shares)	5,030,805	4,488,294
Share-Based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)	2,606,081	2,060,836
Restricted Stock Units (RSUs) [Member]
Antidilutive securities (in shares)	0	2,734
Warrant [Member]
Antidilutive securities (in shares)	2,424,724	2,424,724

v3.23.2

Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Income Tax Expense (Benefit)	$ 0	$ 0

v3.23.2

Note 11 - Related Party Transactions (Details Textual) - Funding Agreement [Member] - BSLF, L.L.C. [Member] - USD ($)	1 Months Ended		3 Months Ended		6 Months Ended
	Mar. 31, 2022	Mar. 29, 2022	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Legal Fees	$ 688,000
Maximum Discount on Legal Service		$ 300,000
Litigation Service, Expense			$ 20,000	$ 43,000	$ 53,000	$ 47,000
Other Liabilities, Current			19,000		19,000		$ 18,000
Loss Contingency Accrual			$ 168,455		$ 168,455

v3.23.2

Note 12 - Contingencies and Uncertainties (Details Textual)	Jun. 30, 2023 USD ($)
BSLF, L.L.C. [Member] | Funding Agreement [Member]
Loss Contingency Accrual	$ 168,455

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