bcda20250930

bcda20250930_10q.htm

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, 2025

☐	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 10,612,734 shares of the registrant’s Common Stock issued and outstanding as of November 11, 2025.

Part I.	FINANCIAL INFORMATION	1

Item 1.	Unaudited Condensed Consolidated Financial Statements	1
	Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024	1
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024	2
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended months ended September 30, 2025 and 2024	3
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	12
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	20
Item 4.	Controls and Procedures	20

Part II.	OTHER INFORMATION	21

Item 1.	Legal Proceedings	21
Item 1A.	Risk Factors	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults Upon Senior Securities	21
Item 4.	Mine Safety Disclosures	21
Item 5.	Other Information	21
Item 6.	Exhibits	22

EXHIBIT INDEX		22
SIGNATURES		23

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, 2024, 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)

	September 30,			December 31,
	2025			2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	5,287		$	2,371
Prepaid expenses and other current assets		78			251
Total current assets		5,365			2,622
Property and equipment, net		13			33
Operating lease right-of-use asset, net		599			898
Other assets		171			171
Total assets	$	6,148		$	3,724
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,080		$	385
Accrued expenses and other current liabilities		1,803			1,551
Operating lease liability - current		427			385
Total current liabilities		3,310			2,321
Operating lease liability - noncurrent		211			566
Total liabilities		3,521			2,887
Commitments and contingencies (Notes 2, 5 and 11)
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of September 30, 2025 and December 31, 2024		—			—
Common stock, $0.001 par value, 50,000,000 shares authorized, 10,608,734 and 4,600,910 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		11			5
Additional paid-in capital		168,981			160,953
Accumulated deficit		(166,365	)		(160,121	)
Total stockholders’ equity		2,627			837
Total liabilities and stockholders’ equity	$	6,148		$	3,724

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						Nine months ended
	September 30,						September 30,
	2025			2024			2025			2024
Revenue:
Collaboration agreement revenue	$	—		$	—		$	—		$	58
Costs and expenses:
Research and development		936			931			3,834			2,972
Selling, general and administrative		552			825			2,431			2,766
Total costs and expenses		1,488			1,756			6,265			5,738
Operating loss		(1,488	)		(1,756	)		(6,265	)		(5,680	)
Other income (expense):
Total other income, net		5			19			21			30
Net loss	$	(1,483	)	$	(1,737	)	$	(6,244	)	$	(5,650	)

Net loss per share, basic and diluted	$	(0.24	)	$	(0.61	)	$	(1.17	)	$	(2.65	)

Weighted-average shares used in computing net loss per share, basic and diluted		6,277,848			2,827,492			5,330,465			2,129,258

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, 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

Balance at December 31, 2024		4,600,910		$	5	$	160,953	$	(160,121	)	$	837
Sale of common stock under ATM, net of issuance costs of $27		81,274			—		185		—			185
Share-based compensation		—			—		170		—			170
Net loss		—			—		—		(2,712	)		(2,712	)
Balance at March 31, 2025		4,682,184			5		161,308		(162,833	)		(1,520	)
Sale of common stock and warrants on April 23, 2025, net of issuance costs of $56		406,818			1		718		—			719
Sale of common stock and warrants on June 30, 2025, net of issuance costs of $9		274,696			—		561		—			561
Sale of common stock under ATM, net of issuance costs of $45		140,104			—		305		—			305
Restricted stock units vested and issued		1,000			—		—		—			—
Share-based compensation		—			—		98		—			98
Net loss		—			—		—		(2,049	)		(2,049	)
Balance at June 30, 2025		5,504,802			6		162,990		(164,882	)		(1,886	)
Sale of common stock and warrants on September 19, 2025, net of issuance costs of $824		4,800,000			4		5,172		—			5,176
Sale of common stock under ATM, net of issuance costs of $40		303,932			1		742		—			743
Share-based compensation		—			—		77		—			77
Net loss		—			—		—		(1,483	)		(1,483	)
Balance at September 30, 2025		10,608,734		$	11	$	168,981	$	(166,365	)	$	2,627

See accompanying notes to the unaudited condensed consolidated financial statements.

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

	Nine months ended September 30,
	2025			2024
Operating activities:
Net loss	$	(6,244	)	$	(5,650	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		21			52
Reduction in the carrying amount of right-of-use assets		299			268
Share-based compensation		345			565
Allowance for doubtful accounts		—			(34	)
Changes in operating assets and liabilities:
Accounts receivable		—			87
Prepaid expenses and other current assets		173			179
Accounts payable		528			(165	)
Accrued expenses and other current liabilities		252			(485	)
Operating lease liability		(313	)		(270	)
Net cash used in operating activities		(4,939	)		(5,453	)
Investing activities:
Purchase of property and equipment		(1	)		(5	)
Net cash used in investing activities		(1	)		(5	)
Financing activities:
Proceeds from sales of common stock		8,690			10,513
Issuance costs of sale of common stock		(834	)		(1,228	)
Net cash provided by financing activities		7,856			9,285
Net change in cash and cash equivalents		2,916			3,827
Cash and cash equivalents at beginning of period		2,371			1,103
Cash and cash equivalents at end of period	$	5,287		$	4,930
Supplemental disclosure of noncash investing and financing activities:
Unpaid issuance costs of common stock	$	173		$	40

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. 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 purpose 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, 2025, and for the three and nine months ended September 30, 2025 and 2024 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, 2025, results of operations for the three and nine months ended September 30, 2025 and 2024, and cash flows for the nine months ended September 30, 2025 and 2024. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ended December 31, 2025 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, 2024, filed with the SEC on March 26, 2025.

(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 $166.4 million as of September 30, 2025. 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 our cash and cash equivalents of approximately $5.3 million as of September 30, 2025 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2026. 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 2026 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 their 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, 2025, approximately 100% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were approximately $5.0 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, 2024, filed with the SEC on March 26, 2025. There have been no changes to those policies.

(g)

Recent Accounting Pronouncements

In November 2024, the Financial Accounting Standards Board (FASB) issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This standard calls for enhanced disclosures about components of expense captions on the face of the income statement. This standard will be effective for fiscal years beginning after December 15, 2026, with the option to apply it retrospectively. Early adoption is allowed. Currently, we are assessing the potential impact of this guidance on our consolidated financial statement disclosures.

Apart from the preceding paragraph, recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on 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 September 30, 2025

	Level 1		Level 2		Level 3		Total
Assets:
Cash in savings account	$	—	$	—	$	—	$	4,628
Cash in checking account		—		—		—		659
Total cash and cash equivalents	$	—	$	—	$	—	$	5,287

	As of December 31, 2024
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		2,058
Cash in checking account		—		—		—		311
Total cash and cash equivalents	$	2	$	—	$	—	$	2,371

(4)

Property and Equipment, Net

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

	September 30,			December 31,
	2025			2024
Computer equipment and software	$	166		$	165
Laboratory and manufacturing equipment		576			576
Furniture and fixtures		27			27
Leasehold improvements		26			26
Property and equipment, gross		795			794
Less accumulated depreciation		(782	)		(761	)
Property and equipment, net	$	13		$	33

Depreciation expense totaled $4,000 and $21,000 for the three and nine months ended September 30, 2025, respectively. Depreciation expense totaled $16,000 and $52,000 for the three and nine months ended September 30, 2024, 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 our 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, 2025 and 2024, and $362,000 for both the nine months ended September 30, 2025 and 2024. The cash paid under the operating lease for base rent was $125,000 and $374,000 for the three and nine months ended September 30, 2025, respectively, and was $122,000 and $364,000 for the three and nine months ended September 30, 2024, respectively. On September 30, 2025, the weighted average remaining lease term was 1.34 years, and the weighted average discount rate was 10.74%.

Future minimum lease payments under the operating lease as of September 30, 2025 were as follows (in thousands):

2025	$	125
2026		514
2027		44
Total undiscounted lease payments		683
Less imputed interest		45
Total operating lease liabilities	$	638

(6)

Accrued Expenses and Other Current Liabilities

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

	September 30,		December 31,
	2025		2024
Accrued expenses	$	108	$	22
Accrued salaries and employee benefits		765		641
Accrued clinical trial costs		391		356
Grant liability		475		468
Customer deposits		64		64
Total	$	1,803	$	1,551

(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. As of September 30, 2025 outstanding warrants had a maximum weighted average term to expiration of 2.8 years.

	Number of		Weighted
	Common Stock		Average
	Equivalents		Exercise Price
Balance as of December 31, 2024		2,467,104	$	3.10
Warrants for common stock sold		5,481,514		1.33
Balance as of September 30, 2025		7,948,618	$	1.88

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 (the February 2024 Offering). 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 February 2024 Offering were $875,000, with associated issuance costs of $43,000.

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) 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.

April 2025 Financing - On April 22, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, as well as certain members of our board of directors and executive officers which closed on April 23, 2025 (the April 2025 Offering). Pursuant to the agreement, we sold 406,818 shares of our common stock, and warrants to purchase an aggregate of 406,818 shares of our common stock at an exercise price equal to $1.905 per share, which are exercisable at any time before the earlier of April 24, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the April 2025 Offering were $775,000, with associated issuance costs of $56,000.

June 2025 Financing - On June 30, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, as well as certain members of our board of directors and executive officers, which closed on June 30, 2025 (the June 2025 Offering). Pursuant to the agreement, we sold 274,696 shares of our common stock, and warrants to purchase an aggregate of 274,696 shares of our common stock at an exercise price equal to $1.95 per share, which are exercisable at any time before the earlier of June 30, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the June 2025 Offering were $570,000, with associated issuance costs of $9,000.

September 2025 Financing - On September 19, 2025, we issued 4,800,000 shares of our common stock, and accompanying warrants to purchase up to 4,800,000 shares of common Stock (the September 2025 Warrants), at a combined offering price of $1.25 per share and September 2025 Warrant (the September 2025 Offering). Each September 2025 Warrant is exercisable at a price per share of $1.25. The September 2025 Warrants expire on September 20, 2027, and are immediately exercisable. Certain of our directors and executive officers purchased an aggregate of 734,400 shares of common Stock and accompanying September 2025 Warrants, representing gross proceeds of $918,000. The gross proceeds of the September 2025 Offering were $6.0 million, with associated issuance costs of $824,000.

At-the-Market (ATM) Offerings – 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 amount of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal. We have filed a prospectus supplement, the ATM 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.

On December 2, 2024, we filed a prospectus supplement to the ATM Prospectus Supplement that updated the maximum aggregate offering amount to approximately $1.3 million. On April 4, 2025, we filed a prospectus supplement that updated the maximum aggregate offering amount that may be sold pursuant to the Sales Agreement to approximately $1.8 million. On July 8, 2025, we filed a prospectus supplement that updated the maximum aggregate offering amount that may be sold pursuant to the Sales Agreement to approximately $3.6 million. As of September 30, 2025, approximately $2.9 million of common stock may still be sold pursuant to the Sales Agreement.

Activity under the Sales Agreement was as follows (in thousands except share amounts):

	Three months ended				Nine months ended
	September 30,				September 30,
	2025		2024		2025		2024
Common shares sold		303,932		—		525,310		412,239
Gross proceeds	$	783	$	—	$	1,345	$	2,438
Associated issuance costs	$	40	$	—	$	112	$	103

(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, 2025 and 2024 was recorded as follows (in thousands):

	Three months ended				Nine months ended
	September 30,				September 30,
	2025		2024		2025		2024
Research and development	$	42	$	98	$	192	$	315
Selling, general and administrative		35		79		153		250
Total share-based compensation	$	77	$	177	$	345	$	565

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, 2024		168,184		$	47.97		6.6	$	—
Stock options forfeited		(3,284	)		38.15
Balance, September 30, 2025		164,900		$	48.17		5.8	$	—
Exercisable, September 30, 2025		134,909		$	55.74		5.2	$	—

Unrecognized share-based compensation for employee and nonemployee options granted through September 30, 2025 is $339,000 to be recognized over a remaining weighted average service period of 1.5 years.

Share-Based Compensation (RSUs)

The following summarizes the activity of non-vested RSUs:

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2024		—		$	n/a
RSUs granted		1,000			2.09
RSUs released		(1,000	)		2.09
Balance, September 30, 2025		—		$	n/a

RSUs vested and settled are converted into our common stock on a one-for-one basis. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The related compensation expense, which is based on the grant date fair value of our common stock multiplied by the number of units granted, is recognized ratably over the period during which the vesting restrictions lapse. Unrecognized share-based compensation for employee and nonemployee RSUs granted through September 30, 2025 was $0.

(9)

Net Loss per Share

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to the net loss position.

The following outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:

	September 30,
	2025		2024

Stock options to purchase common stock		164,900		153,290
Common stock warrants		7,948,618		2,467,104
Total		8,113,518		2,620,394

(10)

Income Taxes

During the three and nine months ended September 30, 2025 and 2024, 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, 2025, 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)

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

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 the Food and Drug Administration (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 for others developing 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)

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate increased capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction, both of which have been demonstrated in small and large animal models of disease.

The CardiAMP cell therapy procedure for heart failure has a specific reimbursement code, C9782, which was established by the Centers for Medicare & Medicaid Services (CMS). This code is used by hospitals to bill for the procedure, including both the treatment and control arms of the CardiAMP Heart Failure Trial.

The CardiAMP Cell Therapy Heart Failure Trial (CardiAMP HF)

CardiAMP HF Trial was a randomized, double-blinded, placebo-procedure controlled study of 115 ischemic heart failure patients with HFrEF enrolled at 18 centers in the United States and Canada. The trial assessed 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. All patients studied were maintained on heart failure medication, with treated patients receiving a single dose of CardiAMP Cell Therapy adjunctive to medication. Two-year results from the trial were presented as a late-breaking clinical trial at the American College of Cardiology Scientific Sessions on March 30, 2025. Results of the CardiAMP HF Trial showed reduction in all cause death, reduced major adverse cardiac events, and improved quality of life, with a composite endpoint that was statistically significant in patients having elevated NTproBNP, a marker of active heart stress.

We have had a positive preliminary clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the CardiAMP Heart Failure Trial two-year data previously provided to the agency. The meeting was held in preparation for the formal clinical consultation on acceptability of the clinical data for submission of an application for approval. PMDA requested additional details including clarification on positioning of the prespecified composite endpoints, background on statistical power, clinical rationale for the NTproBNP subgroup and their risk-benefit profile, anticipated target number of patients in Japan, and clinical development status in the United States. BioCardia anticipates a formal in-person clinical consultation near the end of the year, which could enable us to submit for approval of the CardiAMP system for market entry in Japan.

In the fourth quarter of 2025, we expect to complete submission of the CardiAMP HF data and request a meeting with the FDA to discuss the approvability of CardiAMP Cell Therapy for treatment of ischemic heart failure based on the available clinical data, even as the confirmatory CardiAMP HF II trial is enrolling.

CardiAMP® HF II Phase 3 Trial in Ischemic HFrEF

CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with HFrEF on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study.

The primary endpoint in CardiAMP HF II 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 CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the subset of patients with elevated NTproBNP that are the focus of the CardiAMP HF II study.

Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform. Patient randomization in the trial has commenced at the four actively enrolling centers in the United States. Additional centers are being onboarded. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study.

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 2 and 3 ischemic heart failure trial data and the previous clinical data on CD34+ mononuclear cells in this indication.

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase 3, multi-center, randomized, double-blinded, placebo-controlled study of up to 343 patients at up to 40 clinical sites. The 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. 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.

Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown 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 roll-in cohort patient has recently reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation.

The CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients.

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

The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort now followed by a 360-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities. The study 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 has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The Data Safety Monitoring Board has recommended that the study proceed as designed based on the 30-day data safety assessment from this cohort.

We intend to fund development through nondilutive grants and partnering. Phase 2 development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year. It is expected that after the completion of this Phase 2 study that conditional approval in Japan may be pursued followed by a post-marketing study over a period of five years to further add to the evidence of safety and patient benefit.

Helix™ Biotherapeutic Delivery System

he 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. We intend to submit for approval of the Helix Transendocardial Delivery System (Helix) to FDA as a DeNovo 510(k) application based on its safety and performance in twelve cell and gene therapy clinical studies. The clinical performance of the Helix system sets a high safety standard with more than 4,000 intramyocardial deliveries including studies under CE-mark in Europe. Therapeutic agent retention in the heart has also been shown to be superior using Helix compared to other catheter and surgical delivery approaches.

Morph® DNA Steerable Introducers

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 uniform bending in all directions and a substantial reduction of what is called catheter “whip.” This is expected to enhance physician control for many procedures. For procedures in the left ventricle of the heart, such as cell and gene therapy and ablation of ventricular tachyarrhythmia, we believe it presents significant advantages.

Heart3D™ Fusion Imaging

The Heart3D system is expected to enhance real time two-dimensional X-ray imaging by fusing pre-procedure three-dimensional anatomical heart models created from high quality MRI and CT images for the interventional cardiologist with a focus on cardiac biotherapeutic interventions and biopsies.

Heart3D is expected to be sold initially as a research tool with support services for partners in preclinical studies and subsequently approved for standard clinical practice. The software has performed well in simulated procedures in large animal models with ten intramyocardial injections in thirty minutes using single plane fluoroscopy. It is platform independent and expected to be able to work with most existing MR, CT, and fluoroscopy imaging systems.

Heart3D relies on our intellectual property around fusion imaging with a focus on cardiac biotherapeutic delivery and biopsy and that of our development and commercial partner CART-Tech, B.V., a Netherlands corporation, with whom we have entered into a development, license, and distribution agreement. BioCardia has exclusive licenses and distribution rights for biotherapeutic delivery world-wide and for cardiac biopsy in the United States.

Financial Overview

Revenue

We have no significant revenues at present. Our primary historical and near-term revenue potential is expected to be derived from our biotherapeutic delivery partnering agreements and sale of Morph products. Under these biotherapeutic delivery partnering agreements, we provide extensive support and our Helix biotherapeutic delivery system from the research bench to commercialization for partners. Our FDA-cleared AVANCE and Morph DNA steerable introducer products are available commercially and we are seeking partnerships to advance these primarily for mapping and treating atrial and ventricular tachyarrhythmias.

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 our allogeneic cell therapy trial in heart failure and respiratory distress syndrome. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly, we have not historically allocated resources specifically to our individual programs. There are also significant synergies between these programs.

Selling, General and Administrative Expenses

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

Other Income (Expense)

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

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various judgements that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not clear from other sources. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting policies as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations as well as the specific manner in which we apply those principles. Our critical accounting policies are described in Item 7 in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 26, 2025, which is incorporated by reference herein.

Results of Operations

Comparison of Three and Nine Months Ended September 30, 2025 and 2024

The following table shows our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

	Three months ended September 30,				Nine months ended September 30,
	2025		2024		2025		2024
Revenue:
Collaboration agreement revenue	$	—	$	—	$	—	$	58
Costs and expenses:
Research and development		936		931		3,834		2,972
Selling, general and administrative		552		825		2,431		2,766
Total costs and expenses		1,488		1,756		6,265		5,738
Operating loss

SEC Form 10-Q filed by BioCardia Inc.