10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2024

or

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

Commission file number: 001-38999

BioCardia, Inc.

(Exact name of registrant as specified in its charter)

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

320 Soquel Way 

Sunnyvale, California 94085

(Address of principal executive offices including zip code)

(650) 226-0120

(Registrant’s telephone number, including area code)

N/A

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

1

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

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

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

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

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

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

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

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

There were 4,584,285 shares of the registrant’s Common Stock issued and outstanding as of November 5, 2024.

2

Part I.	FINANCIAL INFORMATION	5
Item 1.	Unaudited Condensed Consolidated Financial Statements	5
	Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	5
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023	6
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended months ended September 30, 2024 and 2023	7
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	8
	Notes to Unaudited Condensed Consolidated Financial Statements	9
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

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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 (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems, our clinical trials, and our business development initiatives, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or resources or other financial items, (iii) our need and 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, (v) our ability to develop and advance current product candidates and programs and execute on our corporate strategy and (vi) the assumptions underlying or relating to any statement described in points (i) – (v) above. 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, 2023, 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.

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PART I. FINANCIAL INFORMATION

ITEM 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

BIOCARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

	September 30,			December 31,
	2024			2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	4,930		$	1,103
Accounts receivable, net of allowance for doubtful accounts of $0 and $34 as of September 30, 2024 and December 31, 2023, respectively		10			63
Prepaid expenses and other current assets		116			295
Total current assets		5,056			1,461
Property and equipment, net		47			94
Operating lease right-of-use asset, net		993			1,261
Other assets		171			171
Total assets	$	6,267		$	2,987
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable	$	569		$	890
Accrued expenses and other current liabilities		1,900			2,385
Operating lease liability - current		371			333
Total current liabilities		2,840			3,608
Operating lease liability - noncurrent		674			982
Total liabilities		3,514			4,590
Commitments and contingencies (Notes 2, 5 and 12)
Stockholders’ equity (deficit):
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of September 30, 2024 and December 31, 2023		—			—
Common stock, $0.001 par value, 50,000,000 and 100,000,000 shares authorized, 4,523,876 and 1,577,769 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively		5			2
Additional paid-in capital		160,573			150,570
Accumulated deficit		(157,825	)		(152,175	)
Total stockholders’ equity (deficit)		2,753			(1,603	)
Total liabilities and stockholders’ equity (deficit)	$	6,267		$	2,987

See accompanying notes to the unaudited condensed consolidated financial statements.

5

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

	Three months ended						Nine months ended
	September 30,						September 30,
	2024			2023			2024			2023
Revenue:
Collaboration agreement revenue	$	—		$	357		$	58		$	464
Costs and expenses:
Research and development		931			1,872			2,972			6,570
Selling, general and administrative		825			1,083			2,766			3,454
Total costs and expenses		1,756			2,955			5,738			10,024
Operating loss		(1,756	)		(2,598	)		(5,680	)		(9,560	)
Other income (expense):
Total other income, net		19			24			30			61
Net loss	$	(1,737	)	$	(2,574	)	$	(5,650	)	$	(9,499	)
Net loss per share, basic and diluted	$	(0.61	)	$	(1.79	)	$	(2.65	)	$	(6.87	)
Weighted-average shares used in computing net loss per share, basic and diluted		2,827,492			1,441,043			2,129,258			1,382,070

See accompanying notes to the unaudited condensed consolidated financial statements.

6

BIOCARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share amounts)

(unaudited)

	Common stock					Additional			Accumulated
	Shares			Cost		paid-in capital			deficit			Total
Balance at December 31, 2022		1,338,451		$	1	$	145,495		$	(140,604	)	$	4,892
Sale of common stock under ATM, net of issuance costs of $13		7,083			—		231			—			231
Exercise of common stock options		13			—		—			—			—
Restricted stock units vested and issued		1,253			—		—			—			—
Share-based compensation		—			—		278			—			278
Net loss		—			—		—			(3,501	)		(3,501	)
Balance at March 31, 2023		1,346,800			1		146,004			(144,105	)		1,900
Sale of common stock under ATM, net of issuance costs of $29		1,907			—		29			—			29
Restricted stock units vested and issued		14,827			—		—			—			—
Restricted stock units issued to settle management bonus obligations		—			—		342			—			342
Share-based compensation		—			—		317			—			317
Sale of common stock on June 21, 2023, net of issuance costs of $177		75,543			—		2,471			—			2,471
Net loss		—			—		—			(3,424	)		(3,424	)
Balance at June 30, 2023		1,439,077			1		149,163			(147,529	)		1,635
Sale of common stock under ATM, net of issuance costs of $48		2,219			—		45			—			45
Issuance costs from sale of common stock on June 21, 2023		—			—		(17	)		—			(17	)
Share-based compensation		—			—		251			—			251
Net loss		—			—		—			(2,574	)		(2,574	)
Balance at September 30, 2023		1,441,296		$	1	$	149,442		$	(150,103	)	$	(660	)
Balance at December 31, 2023		1,577,769		$	2	$	150,570		$	(152,175	)	$	(1,603	)
Sale of common stock under ATM, net of issuance costs of $32		77,127			—		559			—			559
Sale of common stock and warrants on February 13, 2024, net of issuance costs of $43		134,199			—		832			—			832
Share-based compensation		—			—		204			—			204
Net loss		—			—		—			(2,267	)		(2,267	)
Balance at March 31, 2024		1,789,095			2		152,165			(154,442	)		(2,275	)
Sale of common stock under ATM, net of issuance costs of $71		335,112			—		1,776			—			1,776
Reverse stock split fractional share true up		(331	)		—		—			—			—
Share-based compensation		—			—		184			—			184
Net loss		—			—		—			(1,646	)		(1,646	)
Balance at June 30, 2024		2,123,876			2		154,125			(156,088	)		(1,961	)
Sale of common stock and warrants on September 3, 2024, net of issuance costs of $926		2,400,000			3		6,271			—			6,274
Share-based compensation		—			—		177			—			177
Net loss		—			—		—			(1,737	)		(1,737	)
Balance at September 30, 2024		4,523,876		$	5	$	160,573		$	(157,825	)	$	2,753

See accompanying notes to the unaudited condensed consolidated financial statements.

7

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

	Nine months ended September 30,
	2024			2023
Operating activities:
Net loss	$	(5,650	)	$	(9,499	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		52			64
Reduction in the carrying amount of right-of-use assets		268			242
Share-based compensation		565			846
Loss on disposal of property and equipment		—			4
Allowance for doubtful accounts		(34	)		11
Changes in operating assets and liabilities:
Accounts receivable		87			86
Prepaid expenses and other current assets		179			123
Accounts payable		(165	)		(24	)
Accrued expenses and other current liabilities		(485	)		598
Deferred revenue		—			(341	)
Operating lease liability		(270	)		(233	)
Net cash used in operating activities		(5,453	)		(8,123	)
Investing activities:
Purchase of property and equipment		(5	)		(12	)
Net cash used in investing activities		(5	)		(12	)
Financing activities:
Proceeds from sales of common stock		10,513			3,042
Issuance costs of sale of common stock		(1,228	)		(435	)
Net cash provided by financing activities		9,285			2,607
Net change in cash and cash equivalents		3,827			(5,528	)
Cash and cash equivalents at beginning of period		1,103			7,363
Cash and cash equivalents at end of period	$	4,930		$	1,835
Supplemental disclosure of noncash investing and financing activities:
Unpaid issuance costs of common stock	$	40		$	20
Issuance of restricted stock units in lieu of cash bonus obligations	$	—		$	564

See accompanying notes to the unaudited condensed consolidated financial statements.

8

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(1) Summary of Business and Basis of Presentation

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. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced in pivotal trials for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our 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 and our allogeneic cell therapies intended for cardiac indications 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 (deficit), and cash flows as of September 30, 2024, and for the three and nine months ended September 30, 2024 and 2023 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of September 30, 2024, results of operations for the three and nine months ended September 30, 2024 and 2023, and cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 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, 2023, filed with the SEC on March 27, 2024. 

(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 $157.8 million as of September 30, 2024. 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 approximately $4.9 million as of September 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2025. 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.

9

Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond the second quarter of 2025 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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, 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 September 30, 2024, approximately 99% of our cash and cash equivalents were held by one financial institution and total cash and cash equivalents were approximately $4.6 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.

(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, 2023, filed with the SEC on March 27, 2024. 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.

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.

10

The following table shows 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 September 30, 2024
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		4,739
Cash in checking account		—		—		—		189
Total cash and cash equivalents	$	2	$	—	$	—	$	4,930

	As of December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		1,072
Cash in checking account		—		—		—		29
Total cash and cash equivalents	$	2	$	—	$	—	$	1,103

(4) Property and Equipment, Net

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

	September 30,			December 31,
	2024			2023
Computer equipment and software	$	165		$	161
Laboratory and manufacturing equipment		575			574
Furniture and fixtures		27			27
Leasehold improvements		26			26
Property and equipment, gross		793			788
Less accumulated depreciation		(746	)		(694	)
Property and equipment, net	$	47		$	94

Depreciation expense totaled $16,000 and $52,000 for the three and nine months ended September 30, 2024, respectively. Depreciation expense totaled $21,000 and $64,000 for the three and nine months ended September 30, 2023, respectively.

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

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. Our operating lease relates to a property lease for its laboratory and corporate offices which expires in January 2027. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.

ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Our 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 $121,000 for both the three months ended September 30, 2024 and 2023, and $362,000 for both the nine months ended September 30, 2024 and 2023. The cash paid under the operating lease for base rent was $122,000 and $364,000 for the three and nine months ended September 30, 2024, respectively, and was $117,000 and $353,000 for the three and nine months ended September 30, 2023, respectively. On September 30, 2024, the weighted average remaining lease term was 2.34 years, and the weighted average discount rate was 10.74%.

11

Future minimum lease payments under the operating lease as of September 30, 2024 were as follows (in thousands):

Remainder of 2024	$	121
2025		499
2026		514
2027		44
Total undiscounted lease payments		1,178
Less imputed interest		133
Total operating lease liabilities	$	1,045

(6) Accrued Expenses and Other Current Liabilities

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

	September 30,		December 31,
	2024		2023
Accrued expenses	$	28	$	75
Accrued salaries and employee benefits		736		661
Accrued clinical trial costs		597		1,017
Grant liability		470		471
Customer deposits		69		90
Payable to related party		—		71
Total	$	1,900	$	2,385

(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
	Equivalents			Exercise Price
Balance as of December 31, 2023		141,889		$	94.50
Warrants for common stock sold		2,467,104			3.10
Warrants expired		(141,889	)		94.50
Balance as of September 30, 2024		2,467,104		$	3.10

Reverse Stock Split - On May 30, 2024, we effected a 1-for-15 reverse stock split of our common stock, and reduced the authorized common shares from 100,000,000 to 50,000,000. The par value was not adjusted as a result of the reverse stock split. All issued and outstanding common stock, warrants, stock options, restricted stock units and per share amounts contained in the accompanying consolidated financial statements and notes have been retroactively adjusted to give effect to the reverse stock split for all periods presented.

September 2024 Financing - On August 29, 2024, we entered into securities purchase agreements (the Purchase Agreements) with certain purchasers, pursuant to which we agreed to issue, and sell and the purchasers, in the aggregate to buy, in a public offering (the Registered Offering) (i) 1,377,990 shares of our common stock, $0.001 par value per share (the Common Stock), and accompanying warrants to purchase up to 1,377,990 shares of Common Stock (the Common Warrants), at an offering price of $3.00 per share of Common Stock and accompanying Common Warrant, and (ii) pre-funded warrants (the “Pre-Funded Warrants” and together with the Common Warrants the “Warrants”) to purchase up to 1,022,010 shares of Common Stock and accompanying Common Warrants to purchase up to 1,022,010 shares of Common Stock, at an offering price of $2.999 per Pre-Funded Warrant and accompanying Common Warrant. Certain of the Company’s directors and executive officers purchased an aggregate of 211,000 shares of Common Stock and accompanying Common Warrants. The Registered Offering closed on September 3, 2024, with the Company issuing 2,400,000 shares of Common Stock, including the exercise of the Pre-Funded Warrants, and Common Warrants to purchase 2,400,000 shares of Common Stock. Each Common Warrant is exercisable at a price per share of $3.00 and expires on September 3, 2029. The gross proceeds of the Registered Offering were $7.2 million, with associated issuance costs of $926,000.

12

February 2024 Financing - On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 134,199 shares of our common stock, and warrants to purchase 67,104 shares of our common stock at an exercise price equal to $6.60 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.

At-the-Market (ATM) Offerings – On April 12, 2022, we entered into a sales agreement (Cantor 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). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

On December 6, 2023, we entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal, of which $264,000 was available as of September 30, 2024. We have filed a prospectus supplement relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the SEC) on October 19, 2023 and declared effective on December 5, 2023. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

During the three months ended September 30, 2024 and 2023, we sold 0 and 2,219 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $0 and $93,000, with associated issuance costs of $0 and $48,000, respectively. During the nine months ended September 30, 2024 and 2023, we sold 412,239 and 11,209 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $395,000, respectively, with associated issuance costs of $103,000 and $90,000, respectively.

(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 nine months ended September 30, 2024 and 2023 was recorded as follows (in thousands):

	Three months ended				Nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	98	$	118	$	315	$	391
Selling, general and administrative		79		133		250		455
Total share-based compensation	$	177	$	251	$	565	$	846

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

	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrinsic value (in thousands)
Balance, December 31, 2023		165,784		$	52.67		6.8	$	43
Stock options forfeited		(3,177	)		33.97
Stock options expired		(9,317	)		63.09
Balance, September 30, 2024		153,290		$	52.43		6.5	$	—
Exercisable, September 30, 2024		109,830		$	63.83		5.8	$	—

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Unrecognized share-based compensation for employee and nonemployee options granted through September 30, 2024 is $837,000 to be recognized over a remaining weighted average service period of 1.8 years.

Share-Based Compensation (RSUs)

There were no RSUs outstanding and hence there is no unrecognized share-based compensation at September 30, 2024 and December 31, 2023.

(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: 

	September 30,
	2024		2023
Stock options to purchase common stock		153,290		162,934
Common stock warrants		2,467,104		161,648
Total		2,620,394		324,582

(10) Income Taxes

During the three and nine months ended September 30, 2024 and 2023, 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 September 30, 2024, 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.

In March 2022, we entered into confidential settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the Litigation Funding Settlement, 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 remitted the discounts, as received, to the Funder on a quarterly basis. During the three and nine months ended September 30, 2024, we received discounts totaling $0 and $42,000, respectively. During the three and nine months ended September 30, 2023, we received discounts totaling $57,000 and $110,000, respectively. As of September 30, 2024 and December 31, 2023, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $0 and $71,000, respectively. As of September 30, 2024, all of the future potential discounts have been collected and remitted to the Funder.

(12) 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.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the sections titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in this Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.    

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. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced clinically for two cardiac clinical indications based on the mechanism of action of treating microvascular dysfunction demonstrated by these cells in preclinical studies of enhanced microvascular density and reduced fibrosis: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced clinically as an “off the shelf” cell therapy based on the immunomodulatory mechanism of action for the treatment of ischemic inflammatory HFrEF. Our program for these same cells in acute respiratory distress syndrome has had its investigational new drug (IND) approved by FDA, but we have not yet advanced this program in the clinic.

Our therapeutic candidates intended for cardiac indications are enabled by our Helix™ transendocardial biotherapeutic delivery system, which enables minimally invasive catheter-based intramyocardial therapeutic delivery. We partner this therapeutic delivery platform and provide development services selectively 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)

The CardiAMP Cell Therapy Heart Failure Trial

The CardiAMP Heart Failure Trial is a randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of heart failure of reduced ejection fraction (HFrEF). The trial is assessing the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment HFrEF, an investigational device system that has received Breakthrough Device Designation from the FDA. The CardiAMP autologous cell therapy is delivered during a standard minimally invasive catheter-based procedure. Patients are typically discharged after an overnight stay. The cell therapy is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, both of which have been demonstrated in small and large animal models of disease. 

The study enrolled 115 advanced heart failure patients on guideline directed medical therapy, in addition to a 10-patient roll-in cohort. The last protocol specified follow-up visit was completed in October 2024. Close out visits and data monitoring with source data verification to prepare for data lock are expected to be completed in the fourth quarter of 2024. Final data transfer to the independent Statistical Data Analysis Core at the University of Wisconsin is expected soon thereafter for top line data release in the first quarter of 2025.

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We have submitted the Annual Report for the CardiAMP Heart Failure Trial to FDA, which details our plans for completing patient follow-up and we intend to request a meeting with FDA to discuss the results with respect to approvability of the CardiAMP Cell Therapy System. We also completed a supplementary submission to Japan Pharmaceutical and Medical Device Agency (PMDA) providing answers to PMDA’s previous responses on the approvability of the CardiAMP Cell Therapy System based on U.S. data and requested a consultation. This PMDA consultation is scheduled to take place in late November as preparation for a subsequent clinical consultation after results from the CardiAMP Heart Failure Trial are available. Should results meet expectations, there is potential for approval based on this and previous clinical data.

CardiAMP Confirmatory Phase III Trial in Ischemic HFrEF: The CardiAMP Cell Therapy Heart Failure II Trial

The CardiAMP Cell Therapy Heart Failure II Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 250 patients with NTproBNP levels >500 pg/ml at up to 40 centers in the United States. This confirmatory trial focuses on patients in active heart failure who demonstrated the greatest benefits in the interim results of the CardiAMP Heart Failure I Trial. In the interim results with 90% of the follow-up data available, this subgroup of patients showed strong signals of benefit, with 86% relative risk reduction in mortality and the primary outcome measure approaching statistical significance at two years. 

The primary endpoint in the CardiAMP Heart Failure II Trial 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 quality of life at a minimum of 12 months and a maximum of 24 months.

In August 2024, the FDA approved a protocol amendment for the this trial, which allows patients who would have previously been excluded from treatment to receive additional cell deliveries to achieve the same target minimum dosage utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis (CPA). The CPA approach was developed to select patients most likely to respond to therapy based on their therapeutic cell composition at screening. Utilizing available clinical results allowed us to refine the algorithm in the CardiAMP Heart Failure II Trial and develop a personalized treatment plan for patients below the CPA acceptance criteria. Such treatment plans adjust the number of dosing aliquots for patients with lower concentrations of important specified cells. Combined, the algorithm modifications and development of the treatment plan approach are expected to increase the number of patients eligible for the trial.

This trial also includes a 30-day window after patient consent and before baseline measures. This is intended to address the Hawthorne effect, where patient behavior changes can occur after they are under closer observation of their care providers. We have multiple consented patients in the screening queue and many sites that are at various stages of the onboarding process.

CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)

CardiAMP Cell Therapy system, under a second FDA approved investigational device exemption, is being studied in a second related clinical indication of chronic myocardial ischemia with refractory angina. This study is based on the strength of our Phase I and II ischemic heart failure trial data and previous clinical data on CD34+ mononuclear cells in this indication.

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, placebo-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 patients with no option chronic myocardial ischemia with refractory angina (BCDA-02). These patients experience frequent angina (i.e., chest pain) attacks that are uncontrolled by optimal drug therapy, and these patients are not suitable candidates for stent placement or bypass surgery, leaving them few therapeutic options. Our therapeutic approach uses many of the same novel aspects used in the CardiAMP Heart Failure Trial and is expected to leverage our experience and investment in the heart failure trial.

Results from the open label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The last consented patient in the roll-in cohort was treated in August 2024, and we expect top line results of this cohort at the six-month primary endpoint in Q1 2025.

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CardiALLO Allogeneic MSC for Ischemic Heart Failure with HFrEF (BCDA-03)

The FDA approved investigational new drug application (IND) for a Phase I/II trial to deliver our allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort followed by a 60-patient randomized double-blind controlled study and utilizes the Finkelstein Schoenfeld three tier primary composite endpoint of mortality, MACCE, and functional capacity as measured by six-minute walk distance. The low dose cohort of 20 million cells is expected to be completed in the fourth quarter of 2024. There have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response, consistent with our presentation at the Technology and Heart Failure Therapeutics meeting in March 2024.

We intend to fund later development through nondilutive grant applications and partnering. Phase II development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year.

Helix™ Biotherapeutic Delivery System

The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of people suffering from heart disease, offset the costs of biotherapeutic delivery for our own programs, and provide our investors with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic development.

In March 2024, we announced a biotherapeutic delivery partnership with StemCardia through a Phase I/II Clinical Study. Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an IND and the anticipated Phase I/II clinical development to follow. In July 2024, with our partner CellProthera, we jointly announced success from the collaborative Phase II trial of ProtheraCytes in the Excellent cell therapy study in post-myocardial infarction as well as plans to continue the relationship into a Phase III trial.

Morph® Access Innovations

All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. We are actively transitioning all procedures using our Helix transendocardial delivery system to our new FDA cleared Morph DNA platform. We received FDA market clearance of an 8 French equivalent for transseptal cardiac procedures, under the name AVANCE. One of the device’s features is that its tendons are designed to enable deflection rotation around the catheter shaft, providing uniform bending in all directions and a substantial reduction of what is called catheter “whip.” This is designed to enhance physician control for many procedures.

In July 2024, we completed our planned submission to the FDA for clearance of a Morph-DNA product family across a range of diameters and lengths. This product family was designed for the treatment of aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures. The FDA approved this product family for market release in August 2024. We expect that first commercial devices in 45 cm and 70 cm 8 French configurations will be available in November 2024 with additional models to be available in January 2025.

Financial Overview

Revenue

Our primary revenues are derived from our biotherapeutic delivery partnering agreements. Under these partnering agreements, we provide extensive support and our Helix biotherapeutic delivery system from the research bench to commercialization for partners. We also have begun commercializing our FDA cleared AVANCE and Morph DNA steerable introducer products.

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;

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• 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 as we continue the pivotal CardiAMP autologous cell therapy trials in heart failure and chronic myocardial ischemia, and in our CardiALLO allogeneic cell therapy trial in heart failure. 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, 2023, filed with the SEC on March 27, 2024, which is incorporated by reference herein. 

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Results of Operations

Comparison of Three and Nine Months Ended September 30, 2024 and 2023

The following table shows our results of operations for the three and nine months ended September 30, 2024 and 2023 (in thousands): 

	Three months ended September 30,						Nine months ended September 30,
	2024			2023			2024			2023
Revenue:
Collaboration agreement revenue	$	—		$	357		$	58		$	464
Costs and expenses:
Research and development		931			1,872			2,972			6,570
Selling, general and administrative		825			1,083			2,766			3,454
Total costs and expenses		1,756			2,955			5,738			10,024
Operating loss		(1,756	)		(2,598	)		(5,680	)		(9,560	)
Other income (expense):
Total other income, net		19			24			30			61
Net loss	$	(1,737	)	$	(2,574	)	$	(5,650	)	$	(9,499	)

Revenue. Revenue was $0 in the three months ended September 30, 2024 as compared to $357,000 in the three months ended September 30, 2023, and decreased to $58,000 in the nine months ended September 30, 2024 as compared to $464,000 in the nine months ended September 30, 2023. The amount and timing of collaboration revenues is largely dependent on our partners’ development activities and may be inconsistent and create significant variation in our revenues.

Research and Development Expenses. Research and development expenses decreased to $931,000 in the three months ended September 30, 2024 as compared to approximately $1.9 million in the three months ended September 30, 2023, and decreased to approximately $3.0 million in the nine months ended September 30, 2024 as compared to approximately $6.6 million in the nine months ended September 30, 2023, primarily due to reduced personnel costs and clinical expenses following the completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial in the second half of 2023.  

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased to $825,000 in the three months ended September 30, 2024 as compared to approximately $1.1 million in the three months ended September 30, 2023, and decreased to approximately $2.8 million in the nine months ended September 30, 2024 as compared to approximately $3.5 million in the nine months ended September 30, 2023, primarily due to realignment of personnel roles and cost reductions following completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of September 30, 2024, we had an accumulated deficit of approximately $157.8 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 September 30, 2024, we had cash and cash equivalents of approximately $4.9 million. 

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

	Nine months ended September 30,
	2024			2023
Net cash provided by (used in):
Operating activities	$	(5,453	)	$	(8,123	)
Investing activities		(5	)		(12	)
Financing activities		9,285			2,607
Net increase (decrease) in cash and cash equivalents	$	3,827		$	(5,528	)

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. Cash flow used in operating activities decreased from approximately $8.1 million during the nine months ended September 30, 2023 to approximately $5.5 million during the nine months ended September 30, 2024, due primarily to reductions in research and development expense following completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial in the second half of 2023.

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Cash Flows from Investing Activities. Net cash used in investing activities of $5,000 and $12,000 during the nine months ended September 30, 2024 and 2023, respectively, consisted of purchases of property and equipment.

Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $9.3 million and approximately $2.6 million during the nine months ended September 30, 2024 and 2023, respectively, related primarily to proceeds from the sale of common stock and warrants. 

September 2024 Financing - On August 29, 2024, we entered into securities purchase agreements (the Purchase Agreements) with certain purchasers, pursuant to which we agreed to issue, and sell and the purchasers, in the aggregate, to buy, in a public offering (the Registered Offering) (i) 1,377,990 shares of our common stock, $0.001 par value per share (the Common Stock), and accompanying warrants to purchase up to 1,377,990 shares of Common Stock (the Common Warrants), at an offering price of $3.00 per share of Common Stock and accompanying Common Warrant, and (ii) pre-funded warrants (the “Pre-Funded Warrants” and, together with the Common Warrants, the “Warrants”) to purchase up to 1,022,010 shares of Common Stock and accompanying Common Warrants to purchase up to 1,022,010 shares of Common Stock, at an offering price of $2.999 per Pre-Funded Warrant and accompanying Common Warrant. Certain of the Company’s directors and executive officers purchased an aggregate of 211,000 shares of Common Stock and accompanying Common Warrants. The Registered Offering closed on September 3, 2024, with the Company issuing 2,400,000 shares of Common Stock, including the exercise of the Pre-Funded Warrants, and Common Warrants to purchase 2,400,000 shares of Common Stock. Each Common Warrant is exercisable at a price per share of $3.00 and expires on September 3, 2029. The gross proceeds of the Registered Offering were $7.2 million, with associated issuance costs of $926,000.

February 2024 Financing – On February 13, 2024, we sold to certain qualified institutional buyers and institutional accredited investors, as well as Peter Altman, our President and Chief Executive Officer, (i) an aggregate of 134,199 shares of our common stock at an offering price of $6.50 per share and (ii) warrants to purchase an aggregate of 67,104 shares of common stock in a private placement, which warrants were immediately exercisable upon issuance at $6.60 per warrant share (the February 2024 Private Placement). Of such securities, Dr. Altman agreed to purchase (i) 7,207 shares of our common stock and (ii) warrants to purchase 3,603 shares of our common stock. The gross proceeds of the February 2024 Private Placement were $875,000 with associated issuance costs of $43,000.

ATM Offerings

On April 12, 2022, we entered into a sales agreement (Cantor 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). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

On December 6, 2023, we entered into an At-The-Market Offering Agreement (the HCW Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the HCW Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the HCW Sales Agreement through or to HCW as sales agent or principal (the HCW ATM Offering and, together with the Cantor ATM Offering, the ATM Offerings). Pursuant to the terms of the HCW Sales Agreement, we have agreed to pay HCW a commission equal to 3.0% of the gross proceeds from the sales of shares.

During the three months ended September 30, 2024 and 2023, we sold 0 and 2,219 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $0 and $93,000, with associated issuance costs of $0 and $48,000, respectively. During the nine months ended September 30, 2024 and 2023, we sold 412,239 and 11,209 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $395,000, respectively, with associated issuance costs of $103,000 and $90,000, respectively.

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.      

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Based upon our current operating plan, we believe that the cash and cash equivalents of approximately $4.9 million as of September 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2025. In order to continue development of our therapeutic candidates beyond the second quarter of 2025, 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 may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.

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

• the progress, costs, results and timing of our 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; and

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

Until such time that we can generate meaningful revenue from our recurring revenue biotherapeutic delivering partnering business model and/or 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 are able to raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing common stockholders may be highly diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing 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.

21

We have prepared our condensed consolidated financial statements as of September 30, 2024 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 further 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 the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements that are of significance or potential significance to us.

22

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in our market risks during the three months ended September 30, 2024.

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 September 30, 2024, 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 September 30, 2024, 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 September 30, 2024, 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 September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

23

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 risk described below and the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023, 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, 2023, 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.

We have a history of operating losses, and we may not be able to achieve or sustain profitability.

We are a clinical-stage regenerative medicine company and we have not yet generated a profit. We have incurred net losses during each of our fiscal years since our inception. Our net loss for the year ended December 31, 2023 was $11.6 million and our accumulated deficit totaled $152.2 million as of December 31, 2023. We do not know whether or when we will become profitable, if ever. We currently expect operating losses and negative cash flows to continue for at least the next several years.

To date, our only approved or cleared products are our Morph universal deflectable guide catheters and Morph AccessPro sheaths, in the United States and Europe; our AVANCE™ steerable introducer and our Morph DNA deflectable guides in the United States only. Our limited commercialization experience and number of approved products makes it difficult to evaluate our current business and predict our future prospects. Our short commercialization experience and limited number of approved products also makes it difficult for us to forecast our future financial performance and growth and such forecasts are limited and subject to a number of uncertainties, including our ability to successfully complete our Phase III pivotal trials in heart failure and chronic myocardial ischemia and obtain FDA approval for, and then successfully commercialize, the CardiAMP Cell Therapy System.

Our ability to generate sufficient revenue to achieve profitability depends on our ability, either alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize our therapeutic candidates. We do not anticipate generating revenues from sales of our cell therapy systems or any other biotherapeutic candidates within the next few years, and we may never generate sales of these products.

We anticipate that our expenses will increase in the future as we continue to incur significant research and development and other expenses related to our ongoing operations, seek regulatory approvals for our therapeutic candidates, scale-up manufacturing capabilities and hire additional personnel to support the development of our therapeutic candidates and commercialization efforts. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To achieve and maintain profitability, we must successfully develop our therapeutic candidates, obtain regulatory approvals and manufacture, market and sell those products for which we obtain regulatory approvals. If we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our therapeutic candidates may receive approval, and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors and adequate market share for our therapeutic candidates in those markets. We may not succeed in these activities, and we may never generate revenue from product sales that is significant enough to achieve profitability. Our failure to become or remain profitable would depress our market value and could impair our ability to raise capital, expand our business, discover or develop other product candidates or continue our operations. A decline in the value of our company could cause you to lose part or all of your investment.

Our audited consolidated financial statements as of and for the year ended December 31, 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 normal course of business. We have incurred significant losses since our inception and we expect that we will continue to incur losses as we aim to successfully execute our business plan and will be dependent on additional public or private financings, collaborations or licensing arrangements with strategic partners, or additional credit lines or other debt financing sources to fund continuing operations. Absent additional funding, management believes cash and cash equivalents of approximately $4.9 million as of September 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations through the second quarter of 2025. As noted below, we may need to obtain additional funding from equity or debt financings, which may be highly dilutive to our existing stockholders and may require us to agree to burdensome covenants, grant security interests in our assets, enter into collaboration and licensing arrangements that require us to relinquish commercial rights, or grant licenses on terms that are not favorable. For example, in September 2024, we completed the Registered Offering, pursuant to which we issued 2,400,000 shares of common stock, including the shares issued upon the exercise of pre-funded warrants, and common warrants to purchase 2,400,000 shares of common stock. No assurance can be given at this time as to whether we will be able to achieve our fundraising objectives, regardless of the terms. If adequate funds are not available, the Company may be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that may require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations.

24

Our failure to meet the continued listing requirements of the Nasdaq could result in a de-listing of our common stock.

The listing of our common stock on the Nasdaq is contingent on our compliance with the Nasdaq’s conditions for continued listing. We were previously not in compliance with the Nasdaq listing requirements, specifically the requirement to maintain a minimum market value of listed securities of at least $35.0 million (MVLS Requirements), and the Nasdaq listing requirement to maintain a minimum $1.00 per share closing bid price for our common stock (Minimum Bid Price Requirement). Although we have regained compliance with the Minimum Bid Price Requirement and the MVLS requirement, a future failure to maintain  compliance with the Nasdaq’s continued listing requirements could result in our  being subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and security price may decrease and we may experience further difficulties in raising capital, which could materially affect our operations and financial results. Further, delisting from the Nasdaq could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers and employees and could also trigger various defaults under our financing arrangements and other outstanding agreements.

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

During the three months ended September 30, 2024, none of our directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K).

ITEM 6.  EXHIBIT INDEX

Exhibit Number  Exhibit Description

3.1(1) Amended and Restated Certificate of Incorporation, as amended May 29, 2024, as currently in effect

3.2(2) Amended and Restated Bylaws

4.1(3) Form of Pre-Funded Warrant to Purchase Shares of Common Stock of BioCardia, Inc.

4.2(4) Form of Warrant to Purchase Shares of Common Stock

10.1(5)# Form of Securities Purchase Agreement dated August 29, 2024, by and among BioCardia, Inc. and the purchasers identified on the signature pages thereto

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 with applicable taxonomy extension information contained in Exhibits 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.

# Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Company agrees to furnish supplementally a copy of all omitted exhibits and schedules to the Securities and Exchange Commission upon its request.

(1) Previously filed as Exhibit 3.1 to the Registration Statement on Form S-1 filed by us on August 9, 2024.

(2) Previously filed as Exhibit 3.2 to the Current Report on Form 8-K filed by us on May 1, 2023.

(3) Previously filed as Exhibit 4.1 to the Current Report on Form 8-K filed by us on September 3, 2024.

(4) Previously filed as Exhibit 4.2 to the Current Report on Form 8-K filed by us on September 3, 2024.

(5) Previously filed as Exhibit 99.1 to the Current Report on Form 8-K filed by us on September 3, 2024.

25

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:         November 13, 2024	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)
Date:           November 13, 2024	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

26

EX-31.1

Exhibit 31.1

Certification of Principal Executive Officer

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

I, Peter Altman, certify that:

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

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

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

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

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

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

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

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

5.        The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

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

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

Date: November 13, 2024

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

(Principal Executive Officer)

EX-31.2

Exhibit 31.2

Certification of Principal Financial Officer

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

I, David McClung, certify that:

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

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

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

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

(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.        The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

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

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

Date:  November 13, 2024

/s/ David McClung

Name: David McClung

Title: Chief Financial Officer

(Principal Financial Officer)

EX-32.1

Exhibit 32.1

Certification of Principal Executive Officer

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

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

1.      The Quarterly Report on Form 10-Q for the period ended September 30, 2024 (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:  November 13, 2024

/s/ Peter Altman

Name: Peter Altman

Title: President and Chief Executive Officer

(Principal Executive Officer)

EX-32.2

Exhibit 32.2

Certification of Principal Financial Officer

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

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, David McClung, the Chief Financial Officer of BioCardia, Inc. (the “Company”), hereby certify, that, to my knowledge:

1.       The Quarterly Report on Form 10-Q for the period ended September 30, 2024 (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:  November 13, 2024

/s/ David McClung

Name: David McClung

Title: Chief Financial Officer

(Principal Financial Officer)

XML

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2024	Nov. 05, 2024
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-38999
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
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	BCDA
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding (in shares)		4,584,285
Entity Central Index Key	0000925741
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash and cash equivalents	$ 4,930	$ 1,103
Accounts receivable, net of allowance for doubtful accounts of $0 and $34 as of September 30, 2024 and December 31, 2023, respectively	10	63
Prepaid expenses and other current assets	116	295
Total current assets	5,056	1,461
Property and equipment, net	47	94
Operating lease right-of-use asset, net	993	1,261
Other assets	171	171
Total assets	6,267	2,987
Accounts payable	569	890
Accrued expenses and other current liabilities	1,900	2,385
Operating lease liability - current	371	333
Total current liabilities	2,840	3,608
Operating lease liability - noncurrent	674	982
Total liabilities	3,514	4,590
Commitments and Contingencies
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of September 30, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value, 50,000,000 and 100,000,000 shares authorized, 4,523,876 and 1,577,769 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	5	2
Additional paid-in capital	160,573	150,570
Accumulated deficit	(157,825)	(152,175)
Total stockholders’ equity (deficit)	2,753	(1,603)
Total liabilities and stockholders’ equity (deficit)	$ 6,267	$ 2,987

XML

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accounts Receivable, Allowance for Credit Loss, Current	$ 0	$ 34
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)	50,000,000	100,000,000
Common Stock, Shares Authorized (in shares)	50,000,000	100,000,000
Common Stock, Shares, Issued (in shares)	4,523,876	1,577,769
Common Stock, Shares, Outstanding (in shares)	4,523,876	1,577,769

XML

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Total revenue	$ 0	$ 357	$ 58	$ 464
Research and development	931	1,872	2,972	6,570
Selling, general and administrative	825	1,083	2,766	3,454
Total costs and expenses	1,756	2,955	5,738	10,024
Operating loss	(1,756)	(2,598)	(5,680)	(9,560)
Total other income, net	19	24	30	61
Net loss	$ (1,737)	$ (2,574)	$ (5,650)	$ (9,499)
Net loss per share, basic and diluted (in dollars per share)	$ (0.61)	$ (1.79)	$ (2.65)	$ (6.87)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	2,827,492	1,441,043	2,129,258	1,382,070

XML

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member] ATM [Member]	Common Stock [Member] Restricted Stock Units (RSUs) [Member] Management [Member]	Common Stock [Member]	Additional Paid-in Capital [Member] ATM [Member]	Additional Paid-in Capital [Member] Restricted Stock Units (RSUs) [Member] Management [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member] ATM [Member]	Retained Earnings [Member] Restricted Stock Units (RSUs) [Member] Management [Member]	Retained Earnings [Member]	ATM [Member]	Restricted Stock Units (RSUs) [Member] Management [Member]	Total
Balance (in shares) at Dec. 31, 2022			1,338,451
Balance at Dec. 31, 2022			$ 1			$ 145,495			$ (140,604)			$ 4,892
Sale of common stock, net of issuance costs (in shares)	7,083
Sale of common stock, net of issuance costs	$ 0			$ 231			$ 0			$ 231
Exercise of common stock options (in shares)			13
Exercise of common stock options						0						0
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)			1,253
Share-based compensation						278						278
Net loss									(3,501)			(3,501)
Share-based compensation						278						278
Balance (in shares) at Mar. 31, 2023			1,346,800
Balance at Mar. 31, 2023			$ 1			146,004			(144,105)			1,900
Balance (in shares) at Dec. 31, 2022			1,338,451
Balance at Dec. 31, 2022			$ 1			145,495			(140,604)			4,892
Balance (in shares) at Jun. 30, 2023			1,439,077
Balance at Jun. 30, 2023			$ 1			149,163			(147,529)			1,635
Balance (in shares) at Dec. 31, 2022			1,338,451
Balance at Dec. 31, 2022			$ 1			145,495			(140,604)			4,892
Net loss												(9,499)
Balance (in shares) at Sep. 30, 2023			1,441,296
Balance at Sep. 30, 2023			$ 1			149,442			(150,103)			(660)
Balance (in shares) at Mar. 31, 2023			1,346,800
Balance at Mar. 31, 2023			$ 1			146,004			(144,105)			1,900
Sale of common stock, net of issuance costs (in shares)	1,907		75,543
Sale of common stock, net of issuance costs	$ 0		$ 0	29		2,471	0		0	29		2,471
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)			14,827
Share-based compensation			$ 0			317			0			317
Net loss			0			0			(3,424)			(3,424)
Restricted stock units issued to settle management bonus obligations		$ 0			$ 342			$ 0			$ 342
Share-based compensation			$ 0			317			0			317
Balance (in shares) at Jun. 30, 2023			1,439,077
Balance at Jun. 30, 2023			$ 1			149,163			(147,529)			1,635
Sale of common stock, net of issuance costs (in shares)	2,219		0
Sale of common stock, net of issuance costs	$ 0		$ 0	45		17	0		0	45		17
Share-based compensation			0			251			0			251
Net loss			0			0			(2,574)			(2,574)
Share-based compensation			$ 0			251			0			251
Balance (in shares) at Sep. 30, 2023			1,441,296
Balance at Sep. 30, 2023			$ 1			149,442			(150,103)			(660)
Balance (in shares) at Dec. 31, 2023			1,577,769
Balance at Dec. 31, 2023			$ 2			150,570			(152,175)			(1,603)
Sale of common stock, net of issuance costs (in shares)	77,127		134,199
Sale of common stock, net of issuance costs	$ 0		$ 0	559		832	0		0	559		832
Share-based compensation			0			204			0			204
Net loss			0			0			(2,267)			(2,267)
Share-based compensation			$ 0			204			0			204
Balance (in shares) at Mar. 31, 2024			1,789,095
Balance at Mar. 31, 2024			$ 2			152,165			(154,442)			(2,275)
Balance (in shares) at Dec. 31, 2023			1,577,769
Balance at Dec. 31, 2023			$ 2			150,570			(152,175)			(1,603)
Net loss												(5,650)
Balance (in shares) at Sep. 30, 2024			4,523,876
Balance at Sep. 30, 2024			$ 5			160,573			(157,825)			2,753
Balance (in shares) at Mar. 31, 2024			1,789,095
Balance at Mar. 31, 2024			$ 2			152,165			(154,442)			(2,275)
Sale of common stock, net of issuance costs (in shares)	335,112
Sale of common stock, net of issuance costs	$ 0			$ 1,776			$ 0			$ 1,776
Share-based compensation			0			184			0			184
Net loss			$ 0			0			(1,646)			(1,646)
Reverse stock split fractional share true up (in shares)			(331)
Share-based compensation			$ 0			184			0			184
Balance (in shares) at Jun. 30, 2024			2,123,876
Balance at Jun. 30, 2024			$ 2			154,125			(156,088)			(1,961)
Sale of common stock, net of issuance costs (in shares)			2,400,000
Sale of common stock, net of issuance costs			$ 3			6,271			0			6,274
Share-based compensation			0			177			0			177
Net loss			0			0			(1,737)			(1,737)
Share-based compensation			$ 0			177			0			177
Balance (in shares) at Sep. 30, 2024			4,523,876
Balance at Sep. 30, 2024			$ 5			$ 160,573			$ (157,825)			$ 2,753

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Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parentheticals) - USD ($) $ in Thousands		3 Months Ended
	Jun. 30, 2023	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023
ATM [Member]
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs	$ 29		$ 71	$ 32	$ 48		$ 13
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs		$ 926		$ 43		$ 177

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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating activities:
Net loss	$ (5,650)	$ (9,499)
Adjustments to Reconcile Net Income (Loss) to Cash Provided by (Used in) Operating Activities [Abstract]
Depreciation	52	64
Reduction in the carrying amount of right-of-use assets	268	242
Share-based compensation	565	846
Loss on disposal of property and equipment	0	4
Allowance for doubtful accounts	(34)	11
Changes in operating assets and liabilities:
Accounts receivable	87	86
Prepaid expenses and other current assets	179	123
Accounts payable	(165)	(24)
Accrued expenses and other current liabilities	(485)	598
Deferred revenue	0	(341)
Operating lease liability	(270)	(233)
Net cash used in operating activities	(5,453)	(8,123)
us-gaap_NetCashProvidedByUsedInInvestingActivitiesAbstract
Purchase of property and equipment	(5)	(12)
Net cash used in investing activities	(5)	(12)
us-gaap_NetCashProvidedByUsedInFinancingActivitiesAbstract
Proceeds from sales of common stock	10,513	3,042
Issuance costs of sale of common stock	(1,228)	(435)
Net cash provided by financing activities	9,285	2,607
Net change in cash and cash equivalents	3,827	(5,528)
Cash and cash equivalents at beginning of period	1,103	7,363
Cash and cash equivalents at end of period	4,930	1,835
us-gaap_SupplementalCashFlowElementsAbstract
Unpaid issuance costs of common stock	40	20
Issuance of restricted stock units in lieu of cash bonus obligations	$ 0	$ 564

XML

Note 1 - Summary of Business and Basis of Presentation

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Business Description and Basis of Presentation [Text Block]

(1) Summary of Business and Basis of Presentation

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. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced in pivotal trials for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our 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 and our allogeneic cell therapies intended for cardiac indications 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.

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Note 2 - Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

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 (deficit), and cash flows as of September 30, 2024, and for the three and nine months ended September 30, 2024 and 2023 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of September 30, 2024, results of operations for the three and nine months ended September 30, 2024 and 2023, and cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 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, 2023, filed with the SEC on March 27, 2024. 

(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 $157.8 million as of September 30, 2024. 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 approximately $4.9 million as of September 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2025. 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 second quarter of 2025 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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, 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 September 30, 2024, approximately 99% of our cash and cash equivalents were held by one financial institution and total cash and cash equivalents were approximately $4.6 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.

(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, 2023, filed with the SEC on March 27, 2024. 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.

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Note 3 - Fair Value Measurement

9 Months Ended

Sep. 30, 2024

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 shows 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 September 30, 2024
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		4,739
Cash in checking account		—		—		—		189
Total cash and cash equivalents	$	2	$	—	$	—	$	4,930

	As of December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		1,072
Cash in checking account		—		—		—		29
Total cash and cash equivalents	$	2	$	—	$	—	$	1,103

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Note 4 - Property and Equipment, Net

9 Months Ended

Sep. 30, 2024

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):

	September 30,			December 31,
	2024			2023
Computer equipment and software	$	165		$	161
Laboratory and manufacturing equipment		575			574
Furniture and fixtures		27			27
Leasehold improvements		26			26
Property and equipment, gross		793			788
Less accumulated depreciation		(746	)		(694	)
Property and equipment, net	$	47		$	94

Depreciation expense totaled $16,000 and $52,000 for the three and nine months ended September 30, 2024, respectively. Depreciation expense totaled $21,000 and $64,000 for the three and nine months ended September 30, 2023, respectively.

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

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Lessee, Operating Leases [Text Block]

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

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. Our operating lease relates to a property lease for its laboratory and corporate offices which expires in January 2027. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.

ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Our 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 $121,000 for both the three months ended September 30, 2024 and 2023, and $362,000 for both the nine months ended September 30, 2024 and 2023. The cash paid under the operating lease for base rent was $122,000 and $364,000 for the three and nine months ended September 30, 2024, respectively, and was $117,000 and $353,000 for the three and nine months ended September 30, 2023, respectively. On September 30, 2024, the weighted average remaining lease term was 2.34 years, and the weighted average discount rate was 10.74%.

Future minimum lease payments under the operating lease as of September 30, 2024 were as follows (in thousands):

Remainder of 2024	$	121
2025		499
2026		514
2027		44
Total undiscounted lease payments		1,178
Less imputed interest		133
Total operating lease liabilities	$	1,045

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Note 6 - Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2024

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):

	September 30,		December 31,
	2024		2023
Accrued expenses	$	28	$	75
Accrued salaries and employee benefits		736		661
Accrued clinical trial costs		597		1,017
Grant liability		470		471
Customer deposits		69		90
Payable to related party		—		71
Total	$	1,900	$	2,385

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Note 7 - Stockholders' Equity

9 Months Ended

Sep. 30, 2024

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
	Equivalents			Exercise Price
Balance as of December 31, 2023		141,889		$	94.50
Warrants for common stock sold		2,467,104			3.10
Warrants expired		(141,889	)		94.50
Balance as of September 30, 2024		2,467,104		$	3.10

Reverse Stock Split - On May 30, 2024, we effected a 1-for-15 reverse stock split of our common stock, and reduced the authorized common shares from 100,000,000 to 50,000,000. The par value was not adjusted as a result of the reverse stock split. All issued and outstanding common stock, warrants, stock options, restricted stock units and per share amounts contained in the accompanying consolidated financial statements and notes have been retroactively adjusted to give effect to the reverse stock split for all periods presented.

September 2024 Financing - On August 29, 2024, we entered into securities purchase agreements (the Purchase Agreements) with certain purchasers, pursuant to which we agreed to issue, and sell and the purchasers, in the aggregate to buy, in a public offering (the Registered Offering) (i) 1,377,990 shares of our common stock, $0.001 par value per share (the Common Stock), and accompanying warrants to purchase up to 1,377,990 shares of Common Stock (the Common Warrants), at an offering price of $3.00 per share of Common Stock and accompanying Common Warrant, and (ii) pre-funded warrants (the “Pre-Funded Warrants” and together with the Common Warrants the “Warrants”) to purchase up to 1,022,010 shares of Common Stock and accompanying Common Warrants to purchase up to 1,022,010 shares of Common Stock, at an offering price of $2.999 per Pre-Funded Warrant and accompanying Common Warrant. Certain of the Company’s directors and executive officers purchased an aggregate of 211,000 shares of Common Stock and accompanying Common Warrants. The Registered Offering closed on September 3, 2024, with the Company issuing 2,400,000 shares of Common Stock, including the exercise of the Pre-Funded Warrants, and Common Warrants to purchase 2,400,000 shares of Common Stock. Each Common Warrant is exercisable at a price per share of $3.00 and expires on September 3, 2029. The gross proceeds of the Registered Offering were $7.2 million, with associated issuance costs of $926,000.

February 2024 Financing - On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 134,199 shares of our common stock, and warrants to purchase 67,104 shares of our common stock at an exercise price equal to $6.60 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.

At-the-Market (ATM) Offerings – On April 12, 2022, we entered into a sales agreement (Cantor 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). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

On December 6, 2023, we entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal, of which $264,000 was available as of September 30, 2024. We have filed a prospectus supplement relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the SEC) on October 19, 2023 and declared effective on December 5, 2023. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

During the three months ended September 30, 2024 and 2023, we sold 0 and 2,219 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $0 and $93,000, with associated issuance costs of $0 and $48,000, respectively. During the nine months ended September 30, 2024 and 2023, we sold 412,239 and 11,209 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $395,000, respectively, with associated issuance costs of $103,000 and $90,000, respectively.

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Note 8 - Share-based Compensation

9 Months Ended

Sep. 30, 2024

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 nine months ended September 30, 2024 and 2023 was recorded as follows (in thousands):

	Three months ended				Nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	98	$	118	$	315	$	391
Selling, general and administrative		79		133		250		455
Total share-based compensation	$	177	$	251	$	565	$	846

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

	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrinsic value (in thousands)
Balance, December 31, 2023		165,784		$	52.67		6.8	$	43
Stock options forfeited		(3,177	)		33.97
Stock options expired		(9,317	)		63.09
Balance, September 30, 2024		153,290		$	52.43		6.5	$	—
Exercisable, September 30, 2024		109,830		$	63.83		5.8	$	—

Unrecognized share-based compensation for employee and nonemployee options granted through September 30, 2024 is $837,000 to be recognized over a remaining weighted average service period of 1.8 years.

Share-Based Compensation (RSUs)

There were no RSUs outstanding and hence there is no unrecognized share-based compensation at September 30, 2024 and December 31, 2023.

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Note 9 - Net Loss Per Share

9 Months Ended

Sep. 30, 2024

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: 

	September 30,
	2024		2023
Stock options to purchase common stock		153,290		162,934
Common stock warrants		2,467,104		161,648
Total		2,620,394		324,582

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Note 10 - Income Taxes

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Income Tax Disclosure [Text Block]

(10) Income Taxes

During the three and nine months ended September 30, 2024 and 2023, 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 September 30, 2024, 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.   

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Note 11 - Related Party Transactions

9 Months Ended

Sep. 30, 2024

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 confidential settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the Litigation Funding Settlement, 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 remitted the discounts, as received, to the Funder on a quarterly basis. During the three and nine months ended September 30, 2024, we received discounts totaling $0 and $42,000, respectively. During the three and nine months ended September 30, 2023, we received discounts totaling $57,000 and $110,000, respectively. As of September 30, 2024 and December 31, 2023, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $0 and $71,000, respectively. As of September 30, 2024, all of the future potential discounts have been collected and remitted to the Funder.

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Note 12 - Contingencies

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Contingencies Disclosure [Text Block]

(12) 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.

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Insider Trading Arrangements

9 Months Ended

Sep. 30, 2024

Insider Trading Arr Line Items

Material Terms of Trading Arrangement [Text Block]

ITEM 5.  OTHER INFORMATION

During the three months ended September 30, 2024, none of our directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K).

Rule 10b5-1 Arrangement Adopted [Flag]

false

Non-Rule 10b5-1 Arrangement Adopted [Flag]

false

Rule 10b5-1 Arrangement Terminated [Flag]

false

Non-Rule 10b5-1 Arrangement Terminated [Flag]

false

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Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

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 (deficit), and cash flows as of September 30, 2024, and for the three and nine months ended September 30, 2024 and 2023 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of September 30, 2024, results of operations for the three and nine months ended September 30, 2024 and 2023, and cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 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, 2023, filed with the SEC on March 27, 2024. 

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 $157.8 million as of September 30, 2024. 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 approximately $4.9 million as of September 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2025. 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 second quarter of 2025 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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, 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 September 30, 2024, approximately 99% of our cash and cash equivalents were held by one financial institution and total cash and cash equivalents were approximately $4.6 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.

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, 2023, filed with the SEC on March 27, 2024. 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.

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Note 3 - Fair Value Measurement (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

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

	As of September 30, 2024
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		4,739
Cash in checking account		—		—		—		189
Total cash and cash equivalents	$	2	$	—	$	—	$	4,930

	As of December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		1,072
Cash in checking account		—		—		—		29
Total cash and cash equivalents	$	2	$	—	$	—	$	1,103

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Note 4 - Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

Property, Plant and Equipment [Table Text Block]

	September 30,			December 31,
	2024			2023
Computer equipment and software	$	165		$	161
Laboratory and manufacturing equipment		575			574
Furniture and fixtures		27			27
Leasehold improvements		26			26
Property and equipment, gross		793			788
Less accumulated depreciation		(746	)		(694	)
Property and equipment, net	$	47		$	94

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

9 Months Ended

Sep. 30, 2024

Notes Tables

Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]

Remainder of 2024	$	121
2025		499
2026		514
2027		44
Total undiscounted lease payments		1,178
Less imputed interest		133
Total operating lease liabilities	$	1,045

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

9 Months Ended

Sep. 30, 2024

Notes Tables

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

	September 30,		December 31,
	2024		2023
Accrued expenses	$	28	$	75
Accrued salaries and employee benefits		736		661
Accrued clinical trial costs		597		1,017
Grant liability		470		471
Customer deposits		69		90
Payable to related party		—		71
Total	$	1,900	$	2,385

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Note 7 - Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

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

	Number of			Weighted
	Common Stock			Average
	Equivalents			Exercise Price
Balance as of December 31, 2023		141,889		$	94.50
Warrants for common stock sold		2,467,104			3.10
Warrants expired		(141,889	)		94.50
Balance as of September 30, 2024		2,467,104		$	3.10

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Note 8 - Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

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

	Three months ended				Nine months ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	98	$	118	$	315	$	391
Selling, general and administrative		79		133		250		455
Total share-based compensation	$	177	$	251	$	565	$	846

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

	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrinsic value (in thousands)
Balance, December 31, 2023		165,784		$	52.67		6.8	$	43
Stock options forfeited		(3,177	)		33.97
Stock options expired		(9,317	)		63.09
Balance, September 30, 2024		153,290		$	52.43		6.5	$	—
Exercisable, September 30, 2024		109,830		$	63.83		5.8	$	—

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Note 9 - Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

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

	September 30,
	2024		2023
Stock options to purchase common stock		153,290		162,934
Common stock warrants		2,467,104		161,648
Total		2,620,394		324,582

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Note 2 - Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Retained Earnings (Accumulated Deficit)	$ (157,825)	$ (152,175)
Cash and Cash Equivalents, at Carrying Value	$ 4,930	$ 1,103
Cash, Percentage Held in One Financial Institution	99.00%
Cash, Uninsured Amount	$ 4,600

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Note 3 - Fair Value Measurement - Fair Value of Assets Measured on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Total cash and cash equivalents	$ 4,930	$ 1,103
Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	2	2
Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Money Market Funds [Member]
Total cash and cash equivalents	2	2
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	2	2
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member]
Total cash and cash equivalents	4,739	1,072
Savings Account [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member]
Total cash and cash equivalents	189	29
Demand Deposits [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	$ 0	$ 0

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Note 4 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Depreciation	$ 16,000	$ 21,000	$ 52,000	$ 64,000

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Note 4 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property and equipment, gross	$ 793	$ 788
Less accumulated depreciation	(746)	(694)
Property and equipment, net	47	94
Computer Equipment and Software [Member]
Property and equipment, gross	165	161
Laboratory and Manufacturing Equipment [Member]
Property and equipment, gross	575	574
Furniture and Fixtures [Member]
Property and equipment, gross	27	27
Leasehold Improvements [Member]
Property and equipment, gross	$ 26	$ 26

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Note 5 - Operating Lease Right-of-use Asset, Net (Details Textual) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Lease, Payments	$ 121,000	$ 121,000	$ 362,000	$ 362,000
Operating Lease, Payments	$ 122,000	$ 117,000	$ 364,000	$ 353,000
Operating Lease, Weighted Average Remaining Lease Term	2 years 4 months 2 days		2 years 4 months 2 days
Operating Lease, Weighted Average Discount Rate, Percent	10.74%		10.74%

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Note 5 - Operating Lease Right-of-use Asset, Net - Future Minimum Lease Payments Under Operating Lease (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Remainder of 2024	$ 121
2025	499
2026	514
2027	44
Total undiscounted lease payments	1,178
Less imputed interest	133
Total operating lease liabilities	$ 1,045

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Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued expenses	$ 28	$ 75
Accrued salaries and employee benefits	736	661
Accrued clinical trial costs	597	1,017
Grant liability	470	471
Customer deposits	69	90
Total	1,900	2,385
Related Party [Member]
Payable to related party	$ 0	$ 71

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Note 7 - Stockholders' Equity (Details Textual)						3 Months Ended		6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 03, 2024 USD ($) $ / shares shares	Aug. 29, 2024 $ / shares shares	May 30, 2024	Feb. 09, 2024 USD ($) $ / shares shares	Apr. 12, 2022 USD ($)	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) shares	Jun. 30, 2023 USD ($) shares	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($) $ / shares shares	Dec. 06, 2023
Common Stock, Shares Authorized (in shares) | shares						50,000,000			50,000,000		100,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares						$ 0.001			$ 0.001		$ 0.001
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares						$ 3.1			$ 3.1		$ 94.5
Payments of Stock Issuance Costs | $									$ 1,228,000	$ 435,000
Proceeds from Issuance of Common Stock | $									$ 10,513,000	$ 3,042,000
Common Warrants With Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares		1,377,990				2,400,000			2,400,000
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares	$ 3	$ 3
Common Warrants With Stock [Member] | Company Directors and Executive Officers [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares		211,000
Common Warrants Issued With Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares		1,022,010
Prefunded Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares		1,022,010
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares		$ 2.999
Warrants To Purchase Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares				67,104
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares				$ 6.6
Common Stock In 2024 Agreement [Member]
Stock Issued During Period, Shares, New Issues | shares		1,377,990
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares		$ 0.001
Common Warrants With Stock [Member]
Stock Issued During Period, Shares, New Issues | shares	2,400,000
September 2024 Financing [Member]
Proceeds from Issuance or Sale of Equity | $	$ 7,200,000
Payments of Stock Issuance Costs | $	$ 926,000
September 2024 Financing [Member] | Company Directors and Executive Officers [Member]
Stock Issued During Period, Shares, New Issues | shares									211,000
February 2024 Financing [Member]
Stock Issued During Period, Shares, New Issues | shares				134,199
Proceeds from Issuance or Sale of Equity | $				$ 875,000
Payments of Stock Issuance Costs | $				$ 43,000
Sales Agreement with Cantor Fitzgerald Co (Cantor) [Member]
Stock Issued During Period, Shares, New Issues | shares						0	2,219	11,209	412,239
Payments of Stock Issuance Costs | $						$ 0	$ 48,000	$ 90,000	$ 103,000
Sale of Stock, Aggregate Value, Maximum | $					$ 10,500,000
Accrued Sales Commission, Current, Percentage					3.00%
Proceeds from Issuance of Common Stock | $						0	$ 93,000	$ 395,000	2,400,000
Sales Agreement With H.C. Wainwright & Co., LLC [Member]
Sale of Stock, Aggregate Value, Maximum | $											$ 2,750,000
Accrued Sales Commission, Current, Percentage												3.00%
Sale of Stock, Available Value | $						$ 264,000			$ 264,000
Reverse Stock Split [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio			15

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Note 7 - Stockholders' Equity - Warrants (Details)	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Balance , number of common stock warrants (in shares) | shares	141,889
Balance, weighted average exercise price (in dollars per share) | $ / shares	$ 94.5
Warrants for common stock sold , number of common stock warrants (in shares) | shares	2,467,104
Warrants for common stock sold, weighted average exercise price (in dollars per share) | $ / shares	$ 3.1
Warrants expired (in shares) | shares	(141,889)
Warrants expired (in dollars per share) | $ / shares	$ 94.5
Balance , number of common stock warrants (in shares) | shares	2,467,104
Balance as, weighted average exercise price (in dollars per share) | $ / shares	$ 3.1

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Note 8 - Share-based Compensation (Details Textual) - USD ($)	9 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Restricted Stock Units (RSUs) [Member]
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount	$ 0	$ 0
Employees, Non-employees and Non-employee Directors [Member]
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount	$ 837,000
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition	1 year 9 months 18 days

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Note 8 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Total share-based compensation	$ 177	$ 251	$ 565	$ 846
Research and Development Expense [Member]
Total share-based compensation	98	118	315	391
Selling, General and Administrative Expenses [Member]
Total share-based compensation	$ 79	$ 133	$ 250	$ 455

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Note 8 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Balance, number of shares (in shares)		165,784
Balance, weighted average exercise price (in dollars per share)		$ 52.67
Balance, weighted average remaining contractual term (Year)	6 years 6 months	6 years 9 months 18 days
Balance, aggregate intrinsic value	$ 0	$ 43
Stock options granted, number of shares (in shares)	3,177
Stock options granted, weighted average exercise price (in dollars per share)	$ 33.97
Stock options expired (in shares)	(9,317)
Stock options expired (in dollars per share)	$ 63.09
Balance, number of shares (in shares)	153,290
Balance, weighted average exercise price (in dollars per share)	$ 52.43
Exercisable, number of shares (in shares)	109,830
Exercisable, weighted average exercise price (in dollars per share)	$ 63.83
Exercisable, weighted average remaining contractual term (Year)	5 years 9 months 18 days
Exercisable, aggregate intrinsic value	$ 0

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Note 9 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Antidilutive securities (in shares)	2,620,394	324,582
Share-Based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)	153,290	162,934
Warrant [Member]
Antidilutive securities (in shares)	2,467,104	161,648

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Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Tax Expense (Benefit)	$ 0	$ 0	$ 0	$ 0

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Note 11 - Related Party Transactions (Details Textual) - Funding Agreement [Member] - BSLF, L.L.C. [Member] - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
	Mar. 31, 2022	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Legal Fees	$ 688,000
Maximum Discount on Legal Service	$ 300,000
Litigation Service, Expense		$ 0	$ 57,000	$ 42,000	$ 110,000
Other Liabilities, Current		$ 0		$ 0		$ 71,000