bcda20240630

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 June 30, 2024

☐	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)

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 2,123,876 shares of the registrant’s Common Stock issued and outstanding as of July 31, 2024.

Part I.	FINANCIAL INFORMATION	5

Item 1.	Unaudited Condensed Consolidated Financial Statements	5
	Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023	5
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023	6
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and six months ended months ended June 30, 2024 and 2023	7
	Condensed Consolidated Statements of Cash Flows for the six months ended June 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	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4.	Controls and Procedures	22

Part II.	OTHER INFORMATION	23

Item 1.	Legal Proceedings	23
Item 1A.	Risk Factors	23
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3.	Defaults Upon Senior Securities	23
Item 4.	Mine Safety Disclosures	23
Item 5.	Other Information	23
Item 6.	Exhibits	23

EXHIBIT INDEX		23
SIGNATURES		24

FORWARD-LOOKING INFORMATION

This Quarterly Report on Form 10-Q, or report, contains forward-looking statements within the meaning of the U.S. federal securities laws that involve risks and uncertainties. Certain statements contained in this report are not purely historical including, without limitation, statements regarding our expectations, beliefs, intentions, anticipations, commitments or strategies regarding the future that are forward-looking. These statements include those discussed in Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including “Critical Accounting Policies and Estimates,” “Results of Operations,” “Liquidity and Capital Resources,” and “Future Funding Requirements,” and elsewhere in this report.

In this report, the words “may,” “could,” “would,” “might,” “will,” “should,” “plan,” “forecast,” “anticipate,” “believe,” “expect,” “intend,” “estimate,” “predict,” “potential,” “continue,” “future,” “moving toward” or the negative of these terms or other similar expressions also identify forward-looking statements. Our actual results could differ materially from those forward-looking statements contained in this report as a result of a number of risk factors including, but not limited to, those listed in our Annual Report on Form 10-K for the year ended December 31, 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.

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)

	June 30,			December 31,
	2024			2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	1,421		$	1,103
Accounts receivable, net of allowance for doubtful accounts of $0 and $34 as of June 30, 2024 and December 31, 2023, respectively		10			63
Prepaid expenses and other current assets		142			295
Total current assets		1,573			1,461
Property and equipment, net		61			94
Operating lease right-of-use asset, net		1,085			1,261
Other assets		171			171
Total assets	$	2,890		$	2,987
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	1,447		$	890
Accrued expenses and other current liabilities		2,266			2,385
Operating lease liability - current		358			333
Total current liabilities		4,071			3,608
Operating lease liability - noncurrent		780			982
Total liabilities		4,851			4,590
Commitments and contingencies (Notes 2, 5 and 12)
Stockholders’ deficit:
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of June 30, 2024 and December 31, 2023		—			—
Common stock, $0.001 par value, 50,000,000 and 100,000,000 shares authorized, 2,123,876 and 1,577,769 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively		2			2
Additional paid-in capital		154,125			150,570
Accumulated deficit		(156,088	)		(152,175	)
Total stockholders’ deficit		(1,961	)		(1,603	)
Total liabilities and stockholders’ deficit	$	2,890		$	2,987

See accompanying notes to the unaudited condensed consolidated financial statements.

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

	Three months ended						Six months ended
	June 30,						June 30,
	2024			2023			2024			2023
Revenue:
Collaboration agreement revenue		3			43		$	58		$	107
Costs and expenses:
Research and development		800			2,314			2,041			4,698
Selling, general and administrative		852			1,181			1,941			2,371
Total costs and expenses		1,652			3,495			3,982			7,069
Operating loss		(1,649	)		(3,452	)		(3,924	)		(6,962	)
Other income (expense):
Total other income, net		3			28			11			37
Net loss	$	(1,646	)	$	(3,424	)	$	(3,913	)	$	(6,925	)

Net loss per share, basic and diluted	$	(0.88	)	$	(2.52	)	$	(2.20	)	$	(5.12	)

Weighted-average shares used in computing net loss per share, basic and diluted		1,877,069			1,358,968			1,776,305			1,352,094

See accompanying notes to the unaudited condensed consolidated financial statements.

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

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	)

See accompanying notes to the unaudited condensed consolidated financial statements.

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

	Six months ended June 30,
	2024			2023
Operating activities:
Net loss	$	(3,913	)	$	(6,925	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		36			43
Reduction in the carrying amount of right-of-use assets		176			159
Share-based compensation		388			595
Allowance for doubtful accounts		(34	)		—
Changes in operating assets and liabilities:
Accounts receivable		87			86
Prepaid expenses and other current assets		153			70
Accounts payable		561			69
Accrued expenses and other current liabilities		(119	)		353
Deferred revenue		—			(8	)
Operating lease liability		(177	)		(153	)
Net cash used in operating activities		(2,842	)		(5,711	)
Investing activities:
Purchase of property and equipment		(3	)		(12	)
Net cash used in investing activities		(3	)		(12	)
Financing activities:
Proceeds from sales of common stock		3,315			2,950
Issuance costs of sale of common stock		(152	)		(285	)
Net cash provided by financing activities		3,163			2,665
Net change in cash and cash equivalents		318			(3,058	)
Cash and cash equivalents at beginning of period		1,103			7,363
Cash and cash equivalents at end of period	$	1,421		$	4,305
Supplemental disclosure of noncash investing and financing activities:
Unpaid issuance costs of common stock	$	66		$	106
Issuance of restricted stock units in lieu of cash bonus obligations	$	—		$	564

See accompanying notes to the unaudited condensed consolidated financial statements.

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(1)

Summary of Business and Basis of Presentation

Description of Business

		BioCardia, Inc. (we, us, our, BioCardia or the Company), is a clinical-stage company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our 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 of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property.

		We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.

(2)

Significant Accounting Policies

(a)

Basis of Preparation

The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of June 30, 2024, and for the three and six months ended June 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 June 30, 2024, results of operations for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The results for the three and six months ended June 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 $156.1 million as of June 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 $1.4 million as of June 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations through September 2024. 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 through September 2024 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 June 30, 2024, approximately 96% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were approximately $1.1 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.

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 June 30, 2024

	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		1,283
Cash in checking account		—		—		—		136
Total cash and cash equivalents	$	2	$	—	$	—	$	1,421

	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):

	June 30,			December 31,
	2024			2023
Computer equipment and software	$	164		$	161
Laboratory and manufacturing equipment		574			574
Furniture and fixtures		27			27
Leasehold improvements		26			26
Property and equipment, gross		791			788
Less accumulated depreciation		(730	)		(694	)
Property and equipment, net	$	61		$	94

Depreciation expense totaled $17,000 and $36,000 for the three and six months ended June 30, 2024, respectively. Depreciation expense totaled $21,000 and $43,000 for the three and six months ended June 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 $120,000 for both the three months ended June 30, 2024 and 2023, and $241,000 for both the six months ended June 30, 2024 and 2023. The cash paid under the operating lease for base rent was $121,000 and $242,000 for the three and six months ended June 30, 2024, respectively, and was $118,000 and $236,000 for the three and six months ended June 30, 2023, respectively. On June 30, 2024, the weighted average remaining lease term was 2.59 years, and the weighted average discount rate was 10.74%.

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

Remainder of 2024	$	242
2025		499
2026		514
2027		44
Total undiscounted lease payments		1,299
Less imputed interest		161
Total operating lease liabilities	$	1,138

(6)

Accrued Expenses and Other Current Liabilities

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

	June 30,		December 31,
	2024		2023
Accrued expenses	$	4	$	75
Accrued salaries and employee benefits		677		661
Accrued clinical trial costs		1,004		1,017
Grant liability		470		471
Customer deposits		69		90
Payable to related party		42		71
Total	$	2,266	$	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		67,104		6.60
Balance as of June 30, 2024		208,993	$	66.30

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.

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 June 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 June 30, 2024 and 2023, we sold 335,112 and 1,907 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $1.8 million and $58,000, with associated issuance costs of $71,000 and $29,000, respectively. During the six months ended June 30, 2024 and 2023, we sold 412,239 and 8,990 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $302,000, respectively, with associated issuance costs of $103,000 and $42,000, 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 six months ended June 30, 2024 and 2023 was recorded as follows (in thousands):

	Three months ended				Six months ended
	June 30,				June 30,
	2024		2023		2024		2023
Research and development	$	102	$	134	$	217	$	273
Selling, general and administrative		82		183		171		322
Total share-based compensation	$	184	$	317	$	388	$	595

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		(6,965	)		57.37
Balance, June 30, 2024		155,642		$	52.85		6.7	$	—
Exercisable, June 30, 2024		106,464		$	65.79		5.9	$	—

Unrecognized share-based compensation for employee and nonemployee options granted through June 30, 2024 is approximately $1.0 million to be recognized over a remaining weighted average service period of 2.0 years.

Share-Based Compensation (RSUs)

There were no RSUs outstanding and hence there is no unrecognized share-based compensation at June 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:

	June 30,
	2024		2023

Stock options to purchase common stock		155,642		173,738
Common stock warrants		208,993		161,648
Total		364,635		335,386

(10)

Income Taxes

During the three and six months ended June 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 June 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 six months ended June 30, 2024, we received discounts totaling $0 and $42,000, respectively. During the three and six months ended June 30, 2023, we received discounts totaling $20,000 and $53,000, respectively. As of June 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 $42,000 and $71,000, respectively. As of June 30, 2024, all of the future potential discounts have been collected on behalf of 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.

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

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any and all statements contained in this Quarterly Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro- forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Quarterly Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems, 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 other financial items, (iii) our ability to raise additional capital, (iv) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the SEC and (v) the assumptions underlying or relating to any statement described in points (i) – (iv) above. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and elsewhere in this Quarterly Report on Form 10-Q, and those listed in our Annual Report on Form 10-K for the year ended December 31, 2023, which is incorporated by reference herein. Historical results are not necessarily indicative of future results. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.

Overview

We are a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from the bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our immunomodulatory 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 (CardiALLO™), which is actively enrolling, and acute respiratory distress syndrome (ARDS).

Our autologous CardiAMP and our allogeneic CardiALLO cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform 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 an ongoing randomized, double-blinded, controlled clinical trial in the United States with 125 patients enrolled, including a 10-patient roll-in cohort. The last patient randomizations were completed in October 2023 after the trial was determined to be unlikely to meet its primary efficacy endpoint at 12-month follow-up as designed, due primarily to patients in both the treatment and control groups improving on 6MWD, which had an overweight impact on the primary endpoint.

The July 2023 interim results from this study, with 110 of the 115 randomized patients, were presented at the Technology and Heart Failure Therapeutics meeting on March 4, 2024. Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes and hospitalization due to heart failure (MACCE). Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.

In an important subgroup analysis of patients with elevated NTproBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).

We are completing follow-up in CardiAMP HF and preparing this dataset for final lock in the fourth quarter of 2024, and for potential submission to Japan PMDA and the FDA. Results on all 125 patients enrolled with a minimum of one year follow-up are expected to be available in October 2024.

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

The CardiAMP Cell Therapy Heart Failure II Trial was approved by the FDA in the fourth quarter of 2023. The study 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. The primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. Additional endpoints are also being assessed.

Enrollment in the United States commenced in July 2024. We expect to complete enrollment two years after the first patient is randomized.

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

CardiAMP Cell Therapy system, under a second FDA approved investigational device exemption, is actively 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, 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. The Company intends to introduce an adaptive statistical analysis plan with an initial assessment for efficacy when 100 patients reach their primary endpoint, although aspects of this statistical analysis plan remain the subject of study considerations with the FDA.

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.

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

The FDA approval of the investigational new drug application (IND) for a Phase I/II trial to deliver our allogeneic MSC for the treatment of HFrEF was secured in December 2022. This trial 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 cohort receiving the lowest dose of 20 million cells was initiated in December 2023. 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 on March 4, 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 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 lower risk aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures. After selling approximately 12,000 units of an earlier product design, we believe the new design has the potential to become a leader for aorto-ostial applications. A number of leading vascular surgeons and peripherally trained interventional cardiologists have expressed interest in using these new devices after we secure FDA approval.

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;

	•	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.

Results of Operations

Comparison of Three and Six Months Ended June 30, 2024 and 2023

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

	Three months ended June 30,						Six months ended June 30,
	2024			2023			2024			2023
Revenue:
Collaboration agreement revenue	$	3		$	43		$	58		$	107
Costs and expenses:
Research and development		800			2,314			2,041			4,698
Selling, general and administrative		852			1,181			1,941			2,371
Total costs and expenses		1,652			3,495			3,982			7,069
Operating loss		(1,649	)		(3,452	)		(3,924	)		(6,962	)
Other income (expense):
Total other income, net		3			28			11			37
Net loss	$	(1,646	)	$	(3,424	)	$	(3,913	)	$	(6,925	)

Revenue. Revenue decreased to $3,000 in the three months ended June 30, 2024 as compared to $43,000 in the three months ended June 30, 2023, and decreased to $58,000 in the six months ended June 30, 2024 as compared to $107,000 in the six months ended June 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 $800,000 in the three months ended June 30, 2024 as compared to approximately $2.3 million in the three months ended June 30, 2023, and decreased to approximately $2.0 million in the six months ended June 30, 2024 as compared to approximately $4.7 million in the six months ended June 30, 2023, primarily due to clinical staff reductions and reduced personnel related 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 $852,000 in the three months ended June 30, 2024 as compared to approximately $1.2 million in the three months ended June 30, 2023, and decreased to approximately $1.9 million in the six months ended June 30, 2024 as compared to approximately $2.4 million in the six months ended June 30, 2023, primarily due to realignment of personnel roles following staff reductions in the fourth quarter of 2023, and reduced personnel expenses.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of June 30, 2024, we had an accumulated deficit of approximately $156.1 million. We anticipate that we will continue to incur net losses for the next several years.

We have funded our operations principally through the sales of equity and convertible debt securities. As of June 30, 2024, we had cash and cash equivalents of approximately $1.4 million.

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

	Six months ended June 30,
	2024			2023
Net cash provided by (used in):
Operating activities	$	(2,842	)	$	(5,711	)
Investing activities		(3	)		(12	)
Financing activities		3,163			2,665
Net increase (decrease) in cash and cash equivalents	$	318		$	(3,058	)

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 $5.7 million during the six months ended June 30, 2023 to approximately $2.8 million during the six months ended June 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.

Cash Flows from Investing Activities. Net cash used in investing activities of $3,000 and $12,000 during the six months ended June 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 $3.2 million and $2.7 million during the six months ended June 30, 2024 and 2023, respectively, related primarily to proceeds from the sale of common stock and warrants.

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 June 30, 2024 and 2023, we sold 335,112 and 1,907 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $1.8 million and $58,000, with associated issuance costs of $71,000 and $29,000, respectively. During the six months ended June 30, 2024 and 2023, we sold 412,239 and 8,990 shares of common stock, respectively, under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $302,000, respectively, with associated issuance costs of $103,000 and $42,000, respectively.

Registration Statement on Form S-1

In August 2024, we filed with the SEC a registration statement on Form S-1 relating to our potential offering of shares of common stock and warrants to purchase shares of common stock. To the extent an offering under such registration statement is consummated, we expect to use the net proceeds from such offering for general corporate purposes, which may include working capital and other general corporate purposes, which include, but are not limited to, advancing our investigational biotherapeutic candidates and our biotherapeutic delivery partnering business. Such offering, if consummated at all, will depend on a variety of factors, including, among other things, the SEC declaring the registration statement effective, market conditions and the trading price of our common stock, and such offering would be dilutive to our existing stockholders. See “Part II—Item 1A. Risk Factors— If we raise additional capital through the sale of shares of our Common Stock, convertible securities or debt in the future, your ownership in us could be diluted and restrictions could be imposed on our business.”

Future Funding Requirements

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

Based upon our current operating plan, we believe that the cash and cash equivalents of approximately $1.4 million as of June 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations through September 2024. In order to continue development of our therapeutic candidates through September 2024 and to become compliant with the Nasdaq continued listing standards prior to our compliance deadline of September 2, 2024, we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, including the consummation of the offering contemplated by our recently filed registration statement on Form S-1, 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.

We have prepared our condensed consolidated financial statements as of June 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.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in our market risks during the three months ended June 30, 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 June 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 June 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 June 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 June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

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

ITEM 1A. RISK FACTORS

In addition to the 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; and our Helix biotherapeutic delivery system in Europe. 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 $1.4 million as of June 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations through September 2024. 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. 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.

If we do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our common stock could be delisted from the Nasdaq.

The listing of our common stock on the Nasdaq is contingent on our compliance with the Nasdaq’s conditions for continued listing. We are currently not in compliance with Nasdaq listing requirements, specifically the requirement to maintain a minimum market value of listed securities of at least $35.0 million (“MVLS Requirements”), and we were previously not in compliance with the Nasdaq listing requirement to maintain a minimum $1.00 per share closing bid price for our common stock (“Minimum Bid Price Requirement”). On March 6, 2024, and March 12, 2024, we received delisting determination letters from the Nasdaq advising us that we did not regain compliance with the MVLS Requirement and the Minimum Bid Price Requirement, respectively, by the initial compliance dates afforded by the Nasdaq. As a result, trading of our securities on the Nasdaq was subject to suspension at the opening of business on March 15, 2024, and a Form 25-NSE would have been filed with the SEC to remove our securities from listing and registration on the Nasdaq unless we requested an appeal of these determinations to a Nasdaq Hearings Panel (“Panel”). On March 12, 2024, we submitted a hearing request to the Panel to appeal the delisting determinations. Our request for a hearing stayed the suspension of our securities and the filing of a Form 25-NSE pending the Panel’s decision. Following our hearing with the Panel, on May 13, 2024, the Panel granted our request for continued listing on Nasdaq subject to, among other things, (i) us maintaining compliance with the Minimum Bid Price Requirement for ten consecutive trading days on or before June 24, 2024, which occurred following a reverse stock split, and (ii) us demonstrating compliance with minimum stockholders’ equity continued listing requirements under Nasdaq rules on or before September 2, 2024.

If we fail to demonstrate our compliance with the requirements of the Panel’s order, our common stock will be subject to delisting by the Nasdaq. In the event our common stock is no longer listed for trading on Nasdaq, our trading volume and share 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.

If we raise additional capital through the sale of shares of our common stock, convertible securities or debt in the future, your ownership in us could be diluted and restrictions could be imposed on our business.

We may issue shares of our common stock or securities convertible into our common stock to raise additional capital in the future. For example, in August 2024, we filed a registration statement on Form S-1 relating to an offering and sale of common stock and warrants to purchase common stock. While such offering may not be consummated due to a variety of reasons, including the SEC not declaring the registration statement effective, poor market conditions or a decline in the trading price of our common stock, to the extent we issue such securities or securities in any other offering, our stockholders may experience substantial dilution and the trading price of our common stock could decline. If we obtain funds through a credit facility or through the issuance of debt or preferred securities, such debt or preferred securities could have rights senior to your rights as a common shareholder, which could impair the value of our common stock.

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 June 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)	BioCardia 2016 Equity Incentive Plan, as amended
10.1(4)	Amendment to Change of Control and Severance Agreement, dated May 30, 2024, by and between BioCardia, Inc. and Peter Altman
10.2(5)	Amendment to Change of Control and Severance Agreement, dated May 30, 2024, by and between BioCardia, Inc. and David McClung
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.
(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 [•] to the Registration Statement on Form S-1 filed by us on August [9], 2024.
(4)	Previously filed as Exhibit [•] to the Registration Statement on Form S-1 filed by us on August [9], 2024.
(5)	Previously filed as Exhibit [•] to the Registration Statement on Form S-1 filed by us on August [9], 2024.

SIGNATURES

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

	BIOCARDIA, INC. (Registrant)


Date: August 13, 2024	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)


Date: August 13, 2024	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)