BioCardia（BCDA）提交咗截至2026年3月31日嘅第一季10-Q報告，財務狀況依然嚴峻。

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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549 

 

 

 

FORM 10-Q 

 

 

(Mark One) 

 
 
 ☒

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

 
 

 

For the quarterly period ended March 31, 2026

 

or 

 

 
 
 ☐

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

 
 

 

Commission file number: 001-38999

 

 

 

BioCardia, Inc. 

(Exact name of registrant as specified in its charter) 

 

 

 

 
 
 Delaware

 
 
 23-2753988

 
 

 
 
 (State or another jurisdiction of

 incorporation or organization)

 
 
 (I.R.S. Employer

 Identification Number)

 
 

 

320 Soquel Way 

Sunnyvale, California 94085

(Address of principal executive offices including zip code) 

 

(650) 226-0120 

(Registrant’s telephone number, including area code) 

 

N/A 

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

 

 

 

 

 

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 11,374,724 shares of the registrant’s Common Stock issued and outstanding as of May 13, 2026.

 

 

 

 

 

 
 
 Part I.  

 
 
 FINANCIAL INFORMATION

 
 
 1

 
 

 
  
  
  
 

 
 
 Item 1.

 
 
 Unaudited Condensed Consolidated Financial Statements

 
 
 1

 
 

 
  
 
 Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025

 
 
 1

 
 

 
  
 
 Condensed Consolidated Statements of Operations for the three months ended March 31, 2026 and 2025

 
 
 2

 
 

 
  
 
 Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2026 and 2025

 
 
 3

 
 

 
  
 
 Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025

 
 
 4

 
 

 
  
 
 Notes to Unaudited Condensed Consolidated Financial Statements

 
 
 5

 
 

 
 
 Item 2.

 
 
 Management’s Discussion and Analysis of Financial Condition and Results of Operations

 
 
 11

 
 

 
 
 Item 3.

 
 
 Quantitative and Qualitative Disclosures About Market Risk

 
 
 17

 
 

 
 
 Item 4.

 
 
 Controls and Procedures

 
 
 18

 
 

 
  
  
  
 

 
 
 Part II. 

 
 
 OTHER INFORMATION

 
 
 19

 
 

 
  
  
 

 
 
 Item 1.

 
 
 Legal Proceedings

 
 
 19

 
 

 
 
 Item 1A.

 
 
 Risk Factors

 
 
 19

 
 

 
 
 Item 2.

 
 
 Unregistered Sales of Equity Securities and Use of Proceeds

 
 
 19

 
 

 
 
 Item 3.

 
 
 Defaults Upon Senior Securities

 
 
 19

 
 

 
 
 Item 4.

 
 
 Mine Safety Disclosures

 
 
 19

 
 

 
 
 Item 5.

 
 
 Other Information

 
 
 19

 
 

 
 
 Item 6.

 
 
 Exhibits

 
 
 20

 
 

 
  
  
  
 

 
 
 EXHIBIT INDEX

 
 
 20

 
 

 
 
 SIGNATURES

 
 
 21

 
 

 

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, 2025, 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)

 
 

 
  
 

 

 
  
  
 
 March 31,

 
  
  
 
 December 31,

 
  
 

 
 
  

 
  
 
 2026

 
  
  
 
 2025

 
  
 

 
  
  
 
 (unaudited)

 
  
  
  
  
  
 

 
 Assets
  
  
  
  
  
  
  
  
 

 
 
 Current assets:

 
  
  
  
  
  
  
  
  
 

 
 
 Cash and cash equivalents

 
  
 $
 951
  
  
 $
 2,496
  
 

 
 
 Accounts receivable, net of allowance for doubtful accounts of $0 and $0 as of March 31, 2026 and December 31, 2025, respectively

 
  
  
 20
  
  
  
 20
  
 

 
 
 Prepaid expenses

 
  
  
 169
  
  
  
 216
  
 

 
 
 Total current assets

 
  
  
 1,140
  
  
  
 2,732
  
 

 
 
 Property and equipment, net

 
  
  
 16
  
  
  
 16
  
 

 
 
 Operating lease right-of-use asset, net

 
  
  
 385
  
  
  
 494
  
 

 
 
 Other assets

 
  
  
 171
  
  
  
 171
  
 

 
 
 Total assets

 
  
 $
 1,712
  
  
 $
 3,413
  
 

 
 
 Liabilities and Stockholders’ Equity (Deficit)

 
  
  
  
  
  
  
  
  
 

 
 
 Current liabilities:

 
  
  
  
  
  
  
  
  
 

 
 
 Accounts payable

 
  
 $
 820
  
  
 $
 641
  
 

 
 
 Accrued expenses and other current liabilities

 
  
  
 1,546
  
  
  
 1,349
  
 

 
 
 Operating lease liability - current

 
  
  
 412
  
  
  
 442
  
 

 
 
 Total current liabilities

 
  
  
 2,778
  
  
  
 2,432
  
 

 
 
 Operating lease liability - noncurrent

 
  
  
 —
  
  
  
 86
  
 

 
 
 Total liabilities

 
  
  
 2,778
  
  
  
 2,518
  
 

 
 
 Commitments and contingencies (Notes 2, 5 and 11)

 
  
  
 
 
 
  
  
  
 
 
 
  
 

 
 
 Stockholders’ equity (deficit):

 
  
  
  
  
  
  
  
  
 

 
 
 Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of March 31, 2026 and December 31, 2025

 
  
  
 —
  
  
  
 —
  
 

 
 
 Common stock, $0.001 par value, 50,000,000 shares authorized, 10,940,372 and 10,755,647 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 

 
  
  
 11
  
  
  
 11
  
 

 
 
 Additional paid-in capital

 
  
  
 169,531
  
  
  
 169,233
  
 

 
 
 Accumulated deficit

 
  
  
 (170,608
 )
  
  
 (168,349
 )
 

 
 
 Total stockholders’ equity (deficit)

 
  
  
 (1,066
 )
  
  
 895
  
 

 
 
 Total liabilities and stockholders’ equity (deficit)

 
  
 $
 1,712
  
  
 $
 3,413
  
 

 

 
 
 See accompanying notes to the unaudited condensed consolidated financial statements.

 
 

 

1

 

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

 

 
  
  
 
 Three months ended

 
  
 

 
  
  
 
 March 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Costs and expenses:

 
  
  
  
  
  
  
  
  
 

 
 
 Research and development

 
  
 $
 1,235
  
  
 $
 1,530
  
 

 
 
 Selling, general and administrative

 
  
  
 1,031
  
  
  
 1,196
  
 

 
 
 Total costs and expenses

 
  
  
 2,266
  
  
  
 2,726
  
 

 
 
 Operating loss

 
  
  
 (2,266
 )
  
  
 (2,726
 )
 

 
 
 Other income (expense):

 
  
  
  
  
  
  
  
  
 

 
 
 Total other income, net

 
  
  
 7
  
  
  
 14
  
 

 
 
 Net loss

 
  
 $
 (2,259
 )
  
 $
 (2,712
 )
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Net loss per share, basic and diluted

 
  
 $
 (0.21
 )
  
 $
 (0.59
 )
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Weighted-average shares used in computing net loss per share, basic and diluted

 
  
  
 10,812,419
  
  
  
 4,635,764
  
 

 

 
 
 See accompanying notes to the unaudited condensed consolidated financial statements.

 
  
 

 

2

 

 

 

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, 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
 )
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Balance at December 31, 2025

 
  
  
 10,755,647
  
  
 $
 11
  
  
 $
 169,233
  
  
 $
 (168,349
 )
  
 $
 895
  
 

 
 
 Sale of common stock under ATM, net of issuance costs of $40

 
  
  
 184,725
  
  
  
 —
  
  
  
 185
  
  
  
 —
  
  
  
 185
  
 

 
 
 Share-based compensation

 
  
  
 —
  
  
  
 —
  
  
  
 113
  
  
  
 —
  
  
  
 113
  
 

 
 
 Net loss

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 (2,259
 )
  
  
 (2,259
 )
 

 
 
 Balance at March 31, 2026

 
  
  
 10,940,372
  
  
 $
 11
  
  
 $
 169,531
  
  
 $
 (170,608
 )
  
 $
 (1,066
 )
 

 

 
 
 See accompanying notes to the unaudited condensed consolidated financial statements.

 
 

 

3

 

 

 

 
 
 BIOCARDIA, INC.

 
 

 
 
 Condensed Consolidated Statements of Cash Flows

 
 

 
 
 (In thousands)

 
 

 
 
 (unaudited)

 
 

 

 
  
  
 
 Three months ended March 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Operating activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Net loss

 
  
 $
 (2,259
 )
  
 $
 (2,712
 )
 

 
 
 Adjustments to reconcile net loss to net cash used in operating activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Depreciation

 
  
  
 3
  
  
  
 12
  
 

 
 
 Reduction in the carrying amount of right-of-use assets

 
  
  
 121
  
  
  
 121
  
 

 
 
 Share-based compensation

 
  
  
 113
  
  
  
 170
  
 

 
 
 Changes in operating assets and liabilities:

 
  
  
  
  
  
  
  
  
 

 
 
 Prepaid expenses and other current assets

 
  
  
 47
  
  
  
 27
  
 

 
 
 Accounts payable

 
  
  
 247
  
  
  
 422
  
 

 
 
 Accrued expenses and other current liabilities

 
  
  
 197
  
  
  
 467
  
 

 
 
 Operating lease liability

 
  
  
 (128
 )
  
  
 (125
 )
 

 
 
 Net cash used in operating activities

 
  
  
 (1,659
 )
  
  
 (1,618
 )
 

 
 
 Investing activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Purchase of property and equipment

 
  
  
 (3
 )
  
  
 —
  
 

 
 
 Net cash used in investing activities

 
  
  
 (3
 )
  
  
 —
  
 

 
 
 Financing activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Proceeds from sale of common stock

 
  
  
 225
  
  
  
 212
  
 

 
 
 Issuance costs from sale of common stock

 
  
  
 (108
 )
  
  
 (16
 )
 

 
 
 Net cash provided by financing activities

 
  
  
 117
  
  
  
 196
  
 

 
 
 Net change in cash and cash equivalents

 
  
  
 (1,545
 )
  
  
 (1,422
 )
 

 
 
 Cash and cash equivalents at beginning of period

 
  
  
 2,496
  
  
  
 2,371
  
 

 
 
 Cash and cash equivalents at end of period

 
  
 $
 951
  
  
 $
 949
  
 

 
 
 Supplemental disclosure of noncash investing and financing activities:

 
  
  
  
  
  
  
  
  
 

 
 
 Unpaid issuance costs of common stock

 
  
 $
 30
  
  
 $
 17
  
 

 

 
 
 See accompanying notes to the unaudited condensed consolidated financial statements.

 
 

 

4

 

 

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

 

 

 
 
 (1)

 
 
 Summary of Business and Basis of Presentation

 
 

 

 
  
 
 Organization and Description of Business 

 
 

 

BioCardia, Inc. (we, us, our, BioCardia or the Company), is 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 U.S. 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 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.

 

We manage our operations as a single segment for the purpose of assessing performance and making operating decisions, which is how our chief operating decision maker (who is our president and chief executive officer) reviews financial performance and allocates resources. 

 

 

 

 
 
 (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 March 31, 2026, and for the three months ended March 31, 2026 and 2025 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 March 31, 2026, results of operations for the three months ended March 31, 2026 and 2025, and cash flows for the three months ended March 31, 2026 and 2025. The results for the three months ended March 31, 2026 are not necessarily indicative of the results to be expected for the year ended December 31, 2026 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, 2025, filed with the SEC on March 24, 2026. 

 
 

 

 
  
 
 (b)

 
 
 Reclassifications

 
 

 

 
  
 
 Certain prior period balances have been reclassified to conform to current period presentation. 

 
 

 

5

 

 

 
  
 
 (c)

 
 
 Liquidity – Going Concern

 
 

 

 
  
 
 We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $170.6 million as of March 31, 2026. Management expects operating losses and negative cash flows to continue through 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 $951,000 as of March 31, 2026 are not sufficient to fund our planned expenditures and meet our obligations beyond June 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 June 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.

 
 

 

 
  
 
 (d)

 
 
 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, including the assumptions of the estimated incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, and assumptions used for revenue recognition.

 
 

 

 
  
 
 (e)

 
 
 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.

 
 

 

 
  
 
 (f)

 
 
 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 March 31, 2026, approximately 100% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were $704,000 in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.

 
 

 

 
  
 
 (g)

 
 
 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, 2025, filed with the SEC on March 24, 2026. There have been no changes to those policies.

 
 

 

 
  
 
 (h)

 
 
 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.

  

 In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. This ASU clarifies and improves existing interim reporting guidance by consolidating disclosure requirements within Topic 270 and introducing a disclosure principle requiring entities to disclose events and changes occurring after the most recent annual reporting period that are expected to have a material effect on the entity’s financial condition or results of operations. The ASU does not introduce significant changes to recognition or measurement guidance. The amendments in this ASU are effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the effect of adopting this ASU 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.

 
 

 

6

 

 

 

 
 
 (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 March 31, 2026

 
  
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
  
  
 
 Level 1

 
  
  
 
 Level 2

 
  
  
 
 Level 3

 
  
  
 
 Total

 
  
 

 
 
 Assets:

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Cash in savings account

 
  
 $
 —
  
  
 $
 —
  
  
 $
 —
  
  
 $
 765
  
 

 
 
 Cash in checking account

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 186
  
 

 
 
 Total cash and cash equivalents

 
  
 $
 —
  
  
 $
 —
  
  
 $
 —
  
  
 $
 951
  
 

 

 
  
  
 
 As of December 31, 2025

 
  
 

 
  
  
 
 Level 1

 
  
  
 
 Level 2

 
  
  
 
 Level 3

 
  
  
 
 Total

 
  
 

 
 
 Assets:

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Cash in savings account

 
  
 $
 —
  
  
 $
 —
  
  
 $
 —
  
  
 $
 2,258
  
 

 
 
 Cash in checking account

 
  
  
 —
  
  
  
 —
  
  
  
 —
  
  
  
 238
  
 

 
 
 Total cash and cash equivalents

 
  
 $
 —
  
  
 $
 —
  
  
 $
 —
  
  
 $
 2,496
  
 

 

 

 

 
 
 (4) 

 
 
 Property and Equipment, Net

 
 

 

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

 

 
  
  
 
 March 31,

 
  
  
 
 December 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Computer equipment and software

 
  
 $
 174
  
  
 $
 172
  
 

 
 
 Laboratory and manufacturing equipment

 
  
  
 577
  
  
  
 576
  
 

 
 
 Furniture and fixtures

 
  
  
 27
  
  
  
 27
  
 

 
 
 Leasehold improvements

 
  
  
 26
  
  
  
 26
  
 

 
 
 Property and equipment, gross

 
  
  
 804
  
  
  
 801
  
 

 
 
 Less accumulated depreciation

 
  
  
 (788
 )
  
  
 (785
 )
 

 
 
 Property and equipment, net

 
  
 $
 16
  
  
 $
 16
  
 

 

 

 

 
 
 (5) 

 
 
 Leases 

 
 

 

 
  
 
  

 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. Provided that we are not in default under any provision of the lease at the time of exercise of the extension right, and provided further we are occupying the entire premises and have not assigned or sublet any of our interest in this lease, we may extend the term of this lease for one period of 36 months. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.

 
 

 

7

 

 

 
  
 
 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 March 31, 2026 and 2025. The cash paid under the operating lease for base rent was $128,000 and $125,000 for the three months ended March 31, 2026 and 2025, respectively. On March 31, 2026, the weighted average remaining lease term was 0.84 years, and the weighted average discount rate was 10.74%.

 
 

 

 
  
 
 Future minimum lease payments under the operating lease as of March 31, 2026 were as follows (in thousands):

 
 

 

 
 
 2026

 
  
 $
 385
  
 

 
 
 2027

 
  
  
 44
  
 

 
 
 Total undiscounted lease payments

 
  
  
 429
  
 

 
 
 Less imputed interest

 
  
  
 17
  
 

 
 
 Total operating lease liabilities

 
  
 $
 412
  
 

 

 

 

 
 
 (6) 

 
 
 Accrued Expenses and Other Current Liabilities

 
 

 

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

 

 
  
  
 
 March 31,

 
  
  
 
 December 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Accrued expenses

 
  
 $
 52
  
  
 $
 34
  
 

 
 
 Accrued salaries and employee benefits

 
  
  
 694
  
  
  
 524
  
 

 
 
 Accrued clinical trial costs

 
  
  
 261
  
  
  
 256
  
 

 
 
 Grant liability

 
  
  
 475
  
  
  
 471
  
 

 
 
 Customer deposits

 
  
  
 64
  
  
  
 64
  
 

 
 
 Total

 
  
 $
 1,546
  
  
 $
 1,349
  
 

 

 

 

 
 
 (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 March 31, 2026 outstanding warrants had a maximum weighted average term to expiration of 2.3 years.

 

 
  
  
 
 Number of 

 
  
  
 
 Weighted 

 
  
 

 
  
  
 
 Common Stock

 
  
  
 
 Average

 
  
 

 
  
  
 
 Equivalents

 
  
  
 
 Exercise Price

 
  
 

 
 
 Outstanding and exercisable as of December 31, 2025

 
  
  
 7,944,618
  
  
 $
 1.88
  
 

 
 
 Warrants expired

 
  
  
 (67,104
 )
  
  
 6.63
  
 

 
 
 Outstanding and exercisable as of March 31, 2026

 
  
  
 7,877,514
  
  
 $
 1.84
  
 

 

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 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. As of March 31, 2026, approximately $5.1 million of common stock may still be sold pursuant to the Sales Agreement.

 

8

 

 

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

 

 
  
  
 
 Three months ended

 
  
 

 
  
  
 
 March 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Common shares sold

 
  
  
 184,725
  
  
  
 81,274
  
 

 
 
 Gross proceeds

 
  
 $
 225
  
  
 $
 212
  
 

 
 
 Associated issuance costs

 
  
 $
 40
  
  
 $
 27
  
 

 

 

 

 
 
 (8) 

 
 
 Share-Based Compensation 

 
 

 

The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee’s respective function. No share-based compensation was capitalized during the periods presented. Share-based compensation expense for the three months ended March 31, 2026 and 2025 was recorded as follows (in thousands):

 

 
  
  
 
 Three months ended

 
  
 

 
  
  
 
 March 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
 
 Research and development

 
  
 $
 55
  
  
 $
 95
  
 

 
 
 Selling, general and administrative

 
  
  
 58
  
  
  
 75
  
 

 
 
 Total share-based compensation

 
  
 $
 113
  
  
 $
 170
  
 

 

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)

 
  
 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

 
 
 Outstanding, December 31, 2025

 
  
  
 485,203
  
  
 $
 17.19
  
  
  
 8.4
  
  
 $
 —
  
 

 
 
 Stock options granted

 
  
  
 30,000
  
  
  
 1.29
  
  
  
  
  
  
  
  
  
 

 
 
 Stock options forfeited

 
  
  
 (10,193
 )
  
  
 9.94
  
  
  
  
  
  
  
  
  
 

 
 
 Outstanding, March 31, 2026

 
  
  
 505,010
  
  
 $
 16.39
  
  
  
 8.3
  
  
 $
 —
  
 

 
 
 Exercisable, March 31, 2026

 
  
  
 157,036
  
  
 $
 48.34
  
  
  
 5.3
  
  
 $
 —
  
 

 

Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2026 is $534,000 to be recognized over a remaining weighted average service period of 2.3 years.

 

 

 
 
 (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. 

 

9

 

 

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

 

 
  
  
 
 March 31,

 
  
 

 
  
  
 
 2026

 
  
  
 
 2025

 
  
 

 
  
  
  
  
  
  
  
  
  
 

 
 
 Stock options to purchase common stock

 
  
  
 505,010
  
  
  
 168,184
  
 

 
 
 Common stock warrants

 
  
  
 7,877,514
  
  
  
 2,467,104
  
 

 
 
 Total

 
  
  
 8,382,524
  
  
  
 2,635,288
  
 

 

 

 

 
 
 (10) 

 
 
 Income Taxes

 
 

 

During the three months ended March 31, 2026 and 2025, 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 March 31, 2026, 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.

 

 

 

 
 
 (12)

 
 
 Subsequent Events

 
 

 

During the period from April 1, 2026 to May 14, 2026 we sold an aggregate of 434,352 shares of common stock under the Sales Agreement at an average share price of $1.23 for total gross proceeds of $536,000. As of May 14, 2026, approximately $4.5 million of common stock may still be sold pursuant to the Sales Agreement.

 

10

 

 

 

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 U.S. 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 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 (CardiAMP HF)

 

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

 

Clinical data from a 10-patient roll in cohort was published in 2021 in the International Journal of Cardiology. These results concluded that all CardiAMP HF protocol procedures were feasible and well tolerated. Favorable functional, echo and quality of life trends suggest this approach may offer promise. Thereafter, the randomized study enrolled 115 advanced heart failure patients on guideline directed medical therapy, in addition to the initial 10-patient roll-in cohort.

 

Principal results from the trial were presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) Scientific Sessions in March 2025. While the trial did not meet the primary endpoint, two-year results from the trial demonstrated:

 

In patients with elevated NTproBNP biomarkers (50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone had:

 

 
  
 
 ●

 
 
 13% fewer heart death equivalents (i.e., all-cause death, heart transplantation, left ventricular assist device implantation); a 47% relative risk reduction in heart death equivalents

 
 

 
  
 
 ●

 
 
 2% fewer non-fatal major adverse cardiac and cerebrovascular events MACCE; a 16% relative risk reduction in MACCE

 
 

 
  
 
 ●

 
 
 Clinically meaningful 10.5-point improvement in quality-of-life score, as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ)

 
 

 
  
 
 ●

 
 
 13.9-meter improvement in Six Minute Walk Distance

 
 

 

11

 

 

In all treated patients compared to patients on optimized heart failure medication regimen alone, the treated patients had:

 

 
  
 
 ●

 
 
 3.6% fewer heart death equivalents; a 20.9% relative risk reduction in heart death equivalents

 
 

 
  
 
 ●

 
 
 8.7% fewer non-fatal MACCE; a 44.6% relative risk reduction in non-fatal MACCE

 
 

 
  
 
 ●

 
 
 Clinically meaningful 5.5-point improvement in quality of life score, as measured by MLHFQ

 
 

 
  
 
 ●

 
 
 14% fewer non-sustained ventricular tachyarrhythmias and 5.5% fewer sustained ventricular tachyarrhythmias

 
 

 
  
 
 ●

 
 
 Although both treated and controlled patients saw modest improvements in left ventricular ejection fraction, treated patients also showed evidence of reduced left ventricular end diastolic and end systolic volumes

 
 

 

On March 2, 2026, CardiAMP HF echocardiography clinical resu