BioCardia cash insufficient beyond January 2027
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
BioCardia, Inc. (BCDA) reported a $1.817 million net loss for the three months ended September 30, 2026, compared with $1.483 million a year earlier. For the nine months, net loss was $5.689 million versus $6.244 million. Cash and cash equivalents were $2.224 million at September 30, and operating activities used $5.114 million in the nine-month period.
Management said the cash balance was insufficient to fund planned expenditures and meet obligations beyond January 2027, plans to raise additional capital, and disclosed substantial doubt about BioCardia’s ability to continue as a going concern within one year after the statements were issued. FDA meeting minutes say the ongoing CardiAMP HF II trial may support Premarket Approval (PMA). On November 6, 2026, BioCardia reported completing with Japan’s PMDA the process concerning materials required for a regulatory application. FDA accepted a revised Helix pre-submission in October and aims to provide written feedback or hold a meeting within 70 calendar days.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointNine-month net loss narrowed to $5.689 million from $6.244 million.
Negative
- Major point. Forward-looking: it has not happened yet and may not happen.Substantial doubt was disclosed about BioCardia’s ability to continue as a going concern within one year after the statements were issued.
- Minor point. Forward-looking: it has not happened yet and may not happen.$2.224 million in cash was insufficient to fund planned expenditures beyond January 2027.
- Minor pointThird-quarter net loss increased to $1.817 million from $1.483 million.
Filing Explained
As of November 12, 2026, the ATM had no capacity left, while 7,846,514 exercisable warrants remained potential additional shares, not issued shares.
An at-the-market facility lets a company sell new shares gradually into the open market at prevailing prices. BioCardia sold 4,189,055 shares through its facility in the nine months ended
The filing also lists 7,846,514 warrants as outstanding and exercisable to buy common shares at September 30, with a weighted-average exercise price of
Key Figures
Key Terms
going concern financial
At The Market financial
Premarket Approval (PMA) regulatory
Investigational New Drug application (IND) regulatory
Finkelstein-Schoenfeld three tier primary composite endpoint medical
CDISC Standards technical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much cash did BioCardia (BCDA) have at September 30, 2026?
What did the FDA say about BioCardia’s CardiAMP HF II trial?
What is the status of BioCardia’s planned Japan CardiAMP application?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or another jurisdiction of |
(I.R.S. Employer |
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incorporation or organization) |
Identification Number) |
(Address of principal executive offices including zip code)
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(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.
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).
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.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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
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Part I. |
FINANCIAL INFORMATION |
1 |
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Item 1. |
Unaudited Condensed Consolidated Financial Statements |
1 |
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Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
1 |
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Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2026 and 2025 |
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Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2026 and 2025 |
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Condensed Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2026 and 2025 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
18 |
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Item 4. |
Controls and Procedures |
18 |
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Part II. |
OTHER INFORMATION |
19 |
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Item 1. |
Legal Proceedings |
19 |
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Item 1A. |
Risk Factors |
19 |
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Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
19 |
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Item 3. |
Defaults Upon Senior Securities |
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Item 4. |
Mine Safety Disclosures |
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Item 5. |
Other Information |
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Item 6. |
Exhibits |
20 |
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EXHIBIT INDEX |
20 |
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SIGNATURES |
21 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or report, contains forward-looking statements within the meaning of the U.S. federal securities laws that involve risks and uncertainties. Certain statements contained in this report are not purely historical including, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems, our clinical trials, and our business development initiatives, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or resources or other financial items, (iii) our need and ability to raise additional capital, (iv) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the SEC, (v) our expected cash runway and our ability to continue as a going concern, (vii) the timing and outcome of our planned regulatory submissions to, and interactions with, Japan’s Pharmaceutical and Medical Device Agency (PMDA) and the U.S. Food and Drug Administration (FDA), (viii) the timing of enrollment in our clinical trials, (ix) our ability to obtain non-dilutive funding, and (xi) 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, in Part II, Item 1A of this report 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)
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September 30, |
December 31, |
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(unaudited) |
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Current assets: |
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Cash and cash equivalents |
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Accounts receivable, net of allowance for doubtful accounts of $ |
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Prepaid expenses |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset, net |
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Other assets |
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Total assets |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Operating lease liability - current |
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Total current liabilities |
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Operating lease liability - noncurrent |
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Total liabilities |
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Commitments and contingencies (Notes 2, 4 and 10) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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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)
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Three months ended |
Nine months ended |
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September 30, |
September 30, |
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2026 |
2025 |
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2025 |
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Costs and expenses: |
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Research and development |
$ | $ | $ | $ | ||||||||||||
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Selling, general and administrative |
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Total costs and expenses |
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Operating loss |
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Other income (expense): |
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Total other income, net |
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Net loss |
$ | ( |
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) | $ | ( |
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Net loss per share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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See accompanying notes to the unaudited condensed consolidated financial statements. |
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BIOCARDIA, INC.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(In thousands, except share amounts)
(unaudited)
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Common stock |
Additional |
Accumulated |
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Shares |
Cost |
paid-in capital |
deficit |
Total |
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Balance at December 31, 2024 |
$ | $ | $ | ( |
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Sale of common stock under ATM, net of issuance costs of $ |
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at March 31, 2025 |
$ | $ | $ | ( |
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Sale of common stock and warrants on April 23, 2025, net of issuance costs of $ |
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Sale of common stock and warrants on June 30, 2025, net of issuance costs of $ |
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Sale of common stock under ATM, net of issuance costs of $ |
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Restricted stock units vested and issued |
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at June 30, 2025 |
( |
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Sale of common stock and warrants on September 19, 2025, net of issuance costs of $ |
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Sale of common stock under ATM, net of issuance costs of $ |
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at September 30, 2025 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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Balance at December 31, 2025 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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Sale of common stock under ATM, net of issuance costs of $ |
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at March 31, 2026 |
$ | $ | $ | ( |
) | $ | ( |
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Sale of common stock under ATM, net of issuance costs of $ |
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Exercise of September 2025 common stock warrants |
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Restricted stock units vested and issued |
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Restricted stock units issued to settle management bonus obligations |
— | |||||||||||||||||||
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at June 30, 2026 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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Restricted stock units vested and issued |
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Taxes paid related to net share settlement of equity awards |
— | ( |
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Share-based compensation |
— | |||||||||||||||||||
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Net loss |
— | ( |
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Balance at September 30, 2026 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
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See accompanying notes to the unaudited condensed consolidated financial statements. |
BIOCARDIA, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
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Nine months ended September 30, |
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2026 |
2025 |
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Operating activities: |
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Net loss |
$ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Reduction in the carrying amount of right-of-use assets |
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Share-based compensation |
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Changes in operating assets and liabilities: |
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Accounts receivable |
( |
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Prepaid expenses and other current assets |
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Accounts payable |
( |
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Accrued expenses and other current liabilities |
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Operating lease liability |
( |
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Net cash used in operating activities |
( |
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Investing activities: |
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Purchase of property and equipment |
( |
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Net cash used in investing activities |
( |
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Financing activities: |
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Exercise of common stock warrants |
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Taxes paid related to net share settlement of equity awards |
( |
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Proceeds from sale of common stock |
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Issuance costs from sale of common stock |
( |
) | ( |
) | ||||
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Net cash provided by financing activities |
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Net change in cash and cash equivalents |
( |
) | ||||||
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | $ | ||||||
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Supplemental disclosure of noncash investing and financing activities: |
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Unpaid issuance costs of common stock |
$ | $ | ||||||
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Restricted stock units issued to settle management bonus obligations |
$ | $ | ||||||
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Right-of-use asset obtained in exchange for lease obligation |
$ | $ | ||||||
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See accompanying notes to the unaudited condensed consolidated financial statements. |
BioCardia, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
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(1) |
Summary of Business and Basis of Presentation |
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Organization and Description of Business |
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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 CardiALLO™ 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 PulmALLO™ program for these same cells in the pulmonary indication of acute respiratory distress syndrome has had its investigational new drug (IND) approved by the U.S. Food and Drug Administration (FDA). |
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Our therapeutic candidates intended for cardiac indications are enabled by our Helix™ transendocardial biotherapeutic delivery catheters and our Morph™ DNA steerable introducers. We partner this therapeutic delivery platform and provide development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. We are developing Heart3D™ with our partner CART Tech to enhance delivery for our investigational therapies and those of our partners. |
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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. Historically, 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. |
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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. |
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(2) |
Significant Accounting Policies |
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(a) |
Basis of Preparation |
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The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of September 30, 2026, and for the three and nine months ended September 30, 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 September 30, 2026, results of operations for the three and nine months ended September 30, 2026 and 2025, and cash flows for the nine months ended September 30, 2026 and 2025. The results for the three and nine months ended September 30, 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. |
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(b) |
Reclassifications |
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Certain prior period balances have been reclassified to conform to current period presentation. |
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(c) |
Liquidity – Going Concern |
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We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $ |
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Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond January 2027 will require us to raise additional capital, possibly through licensing certain product rights. We plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources 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. |
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(d) |
Use of Estimates |
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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, and right-of-use assets and related liabilities, including the assumptions of the estimated incremental borrowing rate. |
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(e) |
Principles of Consolidation |
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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. |
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(f) |
Concentration of Credit Risk |
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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, 2026, approximately |
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(g) |
Changes to Significant Accounting Policies |
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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. |
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(h) |
Recent Accounting Pronouncements |
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In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 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. |
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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. |
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Apart from the preceding paragraphs, 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. |
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(3) |
Property and Equipment, Net |
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Property and equipment, net consisted of the following (in thousands): |
|
September 30, |
December 31, |
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2026 |
2025 |
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Computer equipment and software |
$ | $ | ||||||
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Laboratory and manufacturing equipment |
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Furniture and fixtures |
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Leasehold improvements |
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Property and equipment, gross |
||||||||
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Less accumulated depreciation |
( |
) | ( |
) | ||||
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Property and equipment, net |
$ | $ | ||||||
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(4) |
Operating Lease Right-of-Use (ROU) |
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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 2028. 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. |
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ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. FASB Accounting Standards Codification ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. Our lease does not provide an implicit rate, and hence 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 was not included in the determination of the present value of lease payments. We have no finance leases. |
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On September 3, 2026, we amended the lease by extending the expiration date by one year to January 31, 2028. As a result of this amendment, we increased our ROU asset and liability by $
Our lease expense for base rent was $ |
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Future minimum lease payments under the operating lease as of September 30, 2026 were as follows (in thousands): |
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2026 |
$ | |||
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2027 |
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2028 |
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Total undiscounted lease payments |
||||
|
Less imputed interest |
||||
|
Total operating lease liabilities |
$ |
|
(5) |
Accrued Expenses and Other Current Liabilities |
|
Accrued expenses and other current liabilities consisted of the following (in thousands): |
|
September 30, |
December 31, |
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|
2026 |
2025 |
|||||||
|
Accrued expenses |
$ | $ | ||||||
|
Accrued salaries and employee benefits |
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|
Accrued clinical trial costs |
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|
Grant liability |
||||||||
|
Customer deposits |
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|
Total |
$ | $ | ||||||
|
(6) |
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. |
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Number of |
Weighted |
|||||||
|
Common Stock |
Average |
|||||||
|
Equivalents |
Exercise Price |
|||||||
|
Outstanding and exercisable as of December 31, 2025 |
$ | |||||||
|
Warrants exercised |
( |
) | ||||||
|
Warrants expired |
( |
) | ||||||
|
Outstanding and exercisable as of September 30, 2026 |
$ | |||||||
The maximum expiration of these warrants as of September 30, 2026 was as follows:
|
Initial warrant inception date |
Maximum warrant expiration date |
Number of Common Stock Equivalents |
Exercise price |
Months until maximum warrant expiration |
||||||||||
|
September 3, 2024 |
|
$ | ||||||||||||
|
April 23, 2025 |
|
|||||||||||||
|
June 30, 2025 |
|
|||||||||||||
|
September 19, 2025 |
|
|||||||||||||
| $ | ||||||||||||||
|
(1) |
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
|
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
September 2025 Financing - On September 19, 2025, we issued |
|
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 were 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 |
|
Activity under the Sales Agreement was as follows (in thousands except share amounts): |
|
Three months ended |
Nine months ended |
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|
September 30, |
September 30, |
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|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Common shares sold |
||||||||||||||||
|
Gross proceeds |
$ | $ | $ | $ | ||||||||||||
|
Associated issuance costs |
$ | $ | $ | $ | ||||||||||||
|
(7) |
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, 2026 and 2025 was recorded as follows (in thousands): |
|
Three months ended |
Nine months ended |
|||||||||||||||
|
September 30, |
September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Research and development |
$ | $ | $ | $ | ||||||||||||
|
Selling, general and administrative |
||||||||||||||||
|
Total share-based compensation |
$ | $ | $ | $ | ||||||||||||
|
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 |
|||||||||||||
|
Outstanding, December 31, 2025 |
$ | $ | ||||||||||||||
|
Stock options granted |
||||||||||||||||
|
Stock options forfeited |
( |
) | ||||||||||||||
|
Stock options expired |
( |
) | ||||||||||||||
|
Outstanding, September 30, 2026 |
$ | $ | ||||||||||||||
|
Exercisable, September 30, 2026 |
$ | $ | ||||||||||||||
|
Unrecognized share-based compensation for employee and nonemployee options granted through September 30, 2026 is $ |
|
The following table summarizes the activity of restricted stock units (RSUs) and related information: |
|
Weighted |
||||||||
|
average |
||||||||
|
grant date |
||||||||
|
Number of |
fair value |
|||||||
|
shares |
per share |
|||||||
|
Balance, December 31, 2025 |
$ | n/a | ||||||
|
RSUs granted |
||||||||
|
RSUs released |
( |
) | ||||||
|
RSUs forfeited |
( |
) | ||||||
|
Balance, September 30, 2026 |
$ | 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 non-employee RSUs granted through September 30, 2026 was $ |
|
(8) |
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. 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, |
||||||||
|
2026 |
2025 |
|||||||
|
Stock options to purchase common stock |
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|
Common stock warrants |
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|
Total |
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|
(9) |
Income Taxes |
|
During the three and nine months ended September 30, 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 September 30, 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. |
|
(10) |
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 and in our Annual Report on Form 10-K for the year ended December 31, 2025, 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 CardiALLO™ 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 PulmALLO™ program for these same cells in the pulmonary indication of acute respiratory distress syndrome has had its investigational new drug (IND) approved by the U.S. Food and Drug Administration (FDA).
Our therapeutic candidates intended for cardiac indications are enabled by our Helix™ transendocardial biotherapeutic delivery catheters and our Morph™ DNA steerable introducers. We partner this therapeutic delivery platform and provide development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. We are developing Heart3D™ with our partner CART Tech to enhance delivery for our investigational therapies and those of our partners.
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 historically 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 autologous cell therapy is a minimally processed mononuclear cell therapy containing CD34+ and CD133 cells and is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis. The therapy is delivered during a standard minimally invasive catheter-based procedure utilizing the Helix biotherapeutic delivery system. Its lead indication is to treat ischemic heart failure of reduced ejection fraction (HFrEF). The CardiAMP Cell Therapy system has been granted Breakthrough Designation from the FDA and is reimbursed by Medicare.
Three clinical trials of the CardiAMP cell therapy for delivery have been completed with a fourth study actively enrolling. The fourth trial has been initiated to confirm the results observed in the CardiAMP HF Trial. In all trials, patients are typically discharged after an overnight stay.
|
● |
Our Phase 1, Transendocardial Autologous Bone Marrow in Myocardial Infarction Trial (TABMMI), National Clinical Trial (NCT) Identifier NCT-00507468, met its primary safety outcome and provided signals of patient benefit including improved exercise tolerance, improved heart function, and reduced mortality. Results were published in the journal Eurointervention in 2011, |
|
● |
Our Phase 2, Transendocardial Autologous Cells in Heart Failure Trial (TACHFT), NCT00768006, also met its primary safety outcome and provided signals of patient benefit when compared to the dedicated placebo group including improved six-minute walk distance, improved quality of life, and reduced major adverse cardiac events. Results for the dedicated placebo group were presented at the World Congress of Regenerative Medicine in 2015 and for the pooled placebo group were published in the Journal of the American Medical Association in 2014. |
|
● |
Our Phase 3, CardiAMP Heart Failure Trial (CardiAMP HF), NCT02438306, was designed based on the Phase II TAC-HFT study to confirm signals of benefit observed relative to its dedicated placebo groups. The trial included biologically informed patient selection based on cell characteristics, point-of-care cell processing to maximize cell viability, targeted transendocardial delivery using the same innovative helical tipped catheter to boost cell retention and in-situ dose as in TAC-HFT and TABMMI, and long-term blinded contrast enhanced echocardiography assessment of ventricular remodeling. Clinical data from the 10-patient roll-in cohort was published in 2021 in the International Journal of Cardiology. The randomized study cohort enrolled 115 patients across 28 centers in the United States, did not achieve its primary efficacy outcome, but met key secondary efficacy outcome in subgroup having elevated biomarkers of heart stress (NTproBNP). Results showed good safety with three treatment-emergent major adverse cardiac events (MACE) which were resolved without sequelae. Efficacy outcomes showed reduced mortality, reduced non-fatal MACE, and improved quality of life, which were statistically significant in the subgroup. Results also showed trends of improved heart function across all patients that were statistically significant in the subgroup. 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 with long term blinded core laboratory contrast enhanced echocardiography results showing enhanced heart function presented at the Late-Breaking Clinical Trials symposium at the Technology and Heart Failure Therapeutics (THT) meeting in March 2026. These presentations are available on the BioCardia website. |
|
● |
Our Phase 3 confirmatory CardiAMP Cell Therapy Heart Failure II Trial is a multi-center, randomized, double-blinded, sham-controlled study of up to 250 patients with NTproBNP levels >500 pg/ml at up to 40 centers in the United States. This confirmatory trial focuses on patients in active heart failure who demonstrated the greatest benefits in the CardiAMP Heart Failure I Trial. The primary endpoint in the CardiAMP Heart Failure II Trial is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. Four clinical sites have enrolled in the study and are actively recruiting patients. In October 2026, we presented the clinical trial design at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix Arizona, including details on the design and scientific support for the CardiAMP™ HF II Study. The objective of the study is to determine efficacy of high dose autologous cell treatment for patients with ischemic heart failure of reduced ejection fraction (HFrEF), who are on guideline directed medical therapy but still exhibit undesirable elevated biomarkers of heart stress. |
In May 2026, we announced that the Japan PMDA Consultation Record of Advice supports regulatory submission for approval of the CardiAMP Cell Therapy for Ischemic Heart Failure based on the Company’s three completed clinical trials of this therapy in HFrEF. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT). PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy.
In June 2026, we announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials.
On November 6, 2026 the Company announced it had successfully completed the process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan. The anticipated Shonin premarket approval application will incorporate PMDA’s advice provided during the consultations.
We are preparing clinical data sets for submission to Japan’s PMDA and the U.S. FDA. We are working with partners to complete the electronic trial master file, conduct good clinical practice audits, and structure clinical research data in accordance with CDISC Standards, which support data consistency, traceability, and regulatory compliance. We also have engaged a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative required for foreign medical device and pharmaceutical companies seeking to sell products in Japan without establishing a local office. In Japan, the DMAH designation may be transferred together with the underlying product approval.
Catalysts ahead for this program include publication of the peer reviewed manuscript for CardiAMP HF, submission for approval in Japan, and ongoing enrollment in the CardiAMP HF II trial.
CardiAMP® Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)
The CardiAMP Cell Therapy system, under a second FDA approved investigational device exemption, is being studied in a second related clinical indication of chronic myocardial ischemia with refractory angina. This study is based on the strength of our Phase I and II ischemic heart failure trial data and previous clinical data on CD34+ mononuclear cells in this indication.
The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study of up to 343 patients at up to 40 clinical sites. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for patients with no-option chronic myocardial ischemia with refractory angina (BCDA-02). These patients experience frequent angina (i.e., chest pain) attacks that are uncontrolled by optimal drug therapy, and these patients are not suitable candidates for stent placement or bypass surgery, leaving them few therapeutic options.
In May 2026, primary results of this cohort were presented at Euro PCR, a world-leading course in interventional cardiovascular medicine. The presentation was made by Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health. Results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, showed that the minimally invasive CardiAMP Cell Therapy procedure was well-tolerated with no treatment emergent major adverse cardiac events. Patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through two years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy (GDMT) and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six months after treatment. This presentation is available on the BioCardia website.
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. With such funding, Phase 2 development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year in the still active trial. 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 to further add to the evidence of safety and patient benefit.
Helix™ Biotherapeutic Delivery System
The Helix transendocardial biotherapeutic delivery system (Helix) is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of people suffering from heart disease, offset the costs of biotherapeutic delivery for our own programs, and provide our investors with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic development.
In February 2026, we announced a Pre-Submission to the FDA under its Q-Submission program for the approval of Helix. In May 2026, BioCardia had this Pre-Submission meeting with FDA. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA’s preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the De Novo pathway. In August 2026, FDA accepted our minutes as formal minutes. In September 2026, we completed our revised Pre-Submission to FDA, which was accepted by FDA in October 2026. The FDA aims to issue written feedback or hold a meeting within 70 calendar days. We expect to hear from the FDA on this Pre-submission in the next five weeks.
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.
Morph® DNA Steerable Introducers
All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. We have FDA market clearances for transseptal cardiac procedures, under the name AVANCE, and for aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures, under the name Morph DNA. One of the device’s patented features is that its tendons are designed to enable deflection rotation around the catheter shaft, providing uniform bending in all directions and a substantial reduction of what is called catheter “whip.” This is designed to enhance physician control for many procedures. These FDA market clearances include a range of diameters and lengths for the devices.
Financial Overview
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. Non-refundable 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 begin our allogeneic cell therapy trials in heart failure and acute respiratory distress syndrome. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly, we have not historically allocated resources specifically to our individual programs. There are also significant synergies between these programs.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other selling, general and administrative expenses include 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 judgments 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, 2025, filed with the SEC on March 24, 2026, which is incorporated by reference herein.
Results of Operations
Comparison of Three and Nine Months Ended September 30, 2026 and 2025
The following table shows our results of operations for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three months ended |
Nine months ended |
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|
September 30, 2026 |
September 30, 2026 |
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|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Costs and expenses: |
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|
Research and development |
$ | 1,235 | $ | 936 | $ | 3,363 | $ | 3,834 | ||||||||
|
Selling, general and administrative |
600 | 552 | 2,361 | 2,431 | ||||||||||||
|
Total costs and expenses |
1,835 | 1,488 | 5,724 | 6,265 | ||||||||||||
|
Operating loss |
(1,835 | ) | (1,488 | ) | (5,724 | ) | (6,265 | ) | ||||||||
|
Other income (expense): |
||||||||||||||||
|
Total other income, net |
18 | 5 | 35 | 21 | ||||||||||||
|
Net loss |
$ | (1,817 | ) | $ | (1,483 | ) | $ | (5,689 | ) | $ | (6,244 | ) | ||||
Research and Development Expenses. Research and development expenses increased to approximately $1.2 million in the three months ended September 30, 2026 as compared to $936,000 in the three months ended September 30, 2025, primarily due to a bonus accrual at a higher level, coupled with increased expenses from regulatory activities to advance CardiAMP in Japan and enrollment in the CardiAMP HF II Trial. Research and development expenses decreased to approximately $3.4 million in the nine months ended September 30, 2026 as compared to approximately $3.8 million in the nine months ended September 30, 2025 primarily due to closeout of the CardiAMP Heart Failure Trial, partially offset by early enrollment in the CardiAMP Heart Failure II Trial and regulatory activities to advance CardiAMP in Japan.
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased to $600,000 in the three months ended September 30, 2026 as compared to $552,000 in the three months ended September 30, 2025, primarily due to a bonus accrual at a higher level. Selling, general and administrative expenses remained consistent at approximately $2.4 million in the nine months ended September 30, 2026 as compared to approximately $2.4 million in the nine months ended September 30, 2025.
Liquidity and Capital Resources
We have incurred net losses each year since our inception and as of September 30, 2026, we had an accumulated deficit of approximately $174.0 million. We anticipate that we will continue to incur net losses for the next several years.
We have funded our operations principally through the sales of equity and convertible debt securities. Currently there are no shares available for sale under the “At The Market” facility. As of September 30, 2026, we had cash and cash equivalents of approximately $2.2 million.
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
Nine months ended |
||||||||
|
September 30 |
||||||||
|
2026 |
2025 |
|||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ | (5,114 | ) | $ | (4,939 | ) | ||
|
Investing activities |
(4 | ) | (1 | ) | ||||
|
Financing activities |
4,846 | 7,856 | ||||||
|
Net increase (decrease) in cash and cash equivalents |
$ | (272 | ) | $ | 2,916 | |||
Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms. Cash flow used in operating activities increased to approximately $5.1 million during the nine months ended September 30, 2026 as compared to approximately $4.9 million during the nine months ended September 30, 2025, primarily due to the timing of payments to suppliers.
Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $4.8 million and approximately $7.9 million during the nine months ended September 30, 2026 and 2025, respectively, related primarily to proceeds from the sale of common stock, partially offset by payments of issuance costs.
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 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), as supplemented, relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares were 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. As of November 12, 2026 and September 30, 2026, we had no capacity to issue shares of common stock under the ATM Prospectus Supplement. 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.
Activity under the Sales Agreement was as follows (in thousands except share amounts):
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Three months ended |
Nine months ended |
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September 30, |
September 30, |
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2026 |
2025 |
2026 |
2025 |
|||||||||||||
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Common shares sold |
— | 303,932 | 4,189,055 | 525,310 | ||||||||||||
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Gross proceeds |
$ | — | $ | 783 | $ | 5,309 | $ | 1,345 | ||||||||
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Associated issuance costs |
$ | — | $ | 40 | $ | 238 | $ | 112 | ||||||||
Future Funding Requirements
To date, we have generated modest revenues. We do not know when, or if, we will generate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our autologous and allogeneic cell therapy candidates unless and until we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations.
Based upon our current operating plan, we believe that the cash and cash equivalents of approximately $2.2 million as of September 30, 2026 are not sufficient to fund our planned expenditures and meet our obligations beyond January 2027. To continue development of our therapeutic candidates beyond such time, we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. We may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.
Our future capital requirements will depend on many factors, including:
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• |
the progress, costs, results and timing of our autologous CardiAMP Cell Therapy System and allogeneic MSC clinical trials and related development programs; |
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• |
FDA acceptance of our autologous CardiAMP Cell Therapy System and allogeneic MSC therapies for heart failure and for other potential indications; |
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• |
the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; |
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• |
the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities; |
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• |
the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development; |
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• |
the ability of our product candidates to progress through clinical development successfully; |
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• |
our need to expand our research and development activities; |
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• |
the costs of acquiring, licensing, or investing in businesses, products, product candidates and technologies; |
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• |
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
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• |
the general and administrative expenses related to being a public company; |
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• |
our need and ability to hire additional management and scientific, medical and sales personnel; |
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• |
the effect of competing technological and market developments; and |
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• |
our need to implement additional internal systems and infrastructure, including financial and reporting systems. |
Until such time that we can generate meaningful revenue from our recurring revenue biotherapeutic delivery partnering business model and/or sales of approved therapies and products, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. To the extent that we are able to raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing common stockholders may be highly diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, products, or therapeutic candidates or to grant licenses on terms that may not be favorable to us.
We have prepared our condensed consolidated financial statements as of September 30, 2026 on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about our ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend, in a large part, on our ability to raise additional capital. If adequate funds are not available, we may be required to further reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.
The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are unable to continue as a going concern, we may be forced to liquidate assets. In such a scenario, the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed consolidated financial statements.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the Securities and Exchange Commission.
Recent Accounting Pronouncements
See Note 2 of our notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements that are of significance or potential significance to us.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes in our market risks during the three months ended September 30, 2026.
Our exposure to market risk is currently limited to our cash and cash equivalents, all of which have maturities of less than three months. The goals of our investment policy are preservation of capital, maintenance of liquidity needs, and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk or departing from our investment policy. We currently do not hedge interest rate exposure. Because of the short-term nature of our cash equivalents, we do not believe that an increase in market rates would have a material negative impact on the value of our portfolio.
Interest Rate Risk
As of September 30, 2026, based on current interest rates and total borrowings outstanding, a hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on our results of operations.
Foreign Currency Exchange Risks
We are a U.S. entity and our functional currency is the U.S. dollar. The vast majority of our revenues were derived from sales in the United States. We have business transactions in foreign currencies; however, we believe we do not have significant exposure to risk from changes in foreign currency exchange rates at this time. We do not currently engage in hedging or similar transactions to reduce our foreign currency risks. We will continue to monitor and evaluate our internal processes relating to foreign currency exchange, including the potential use of hedging strategies.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
In connection with the preparation of this Quarterly Report on Form 10-Q, as of September 30, 2026, an evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of September 30, 2026, our disclosure controls and procedures were, in design and operation, effective at a reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes to our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management does not believe that the Company is party to any current pending legal proceedings. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows.
ITEM 1A. RISK FACTORS
In addition to the risk described below and the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025, which could materially affect our business, financial condition, or future results, and which are incorporated by reference herein. The risks described in this report, our Annual Report on Form 10-K for the year ended December 31, 2025, and our Quarterly Reports on Form 10-Q filed periodically with the SEC are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition or future results.
Our existing and any future contractual arrangement that we expect will provide us access to capital may provide less capital than expected and on a delayed basis.
We have, and may in the future enter into, contractual arrangements that are designed to facilitate our access to capital. In December 2023, we entered into a sales agreement (HCW Sales Agreement) with H.C. Wainwright & Co., LLC (HCW) pursuant to which we may sell shares of our common stock through HCW as the sales agent at current market prices (HCW ATM Offering). However, there no shares of our common stock available to sell under the HCW Sales Agreement as of September 30, 2026. Even if additional capacity becomes available, the amounts we sell under the HCW ATM Offering may not satisfy all of our funding needs and our receipt of any funds thereunder may not be received on a timely basis, even if we are able and choose to sell and issue all of our common stock otherwise issuable pursuant to the HCW Sales Agreement.
Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the HCW Sales Agreement or under our equity incentive plans, could result in additional dilution of the percentage ownership of our existing stockholders and could cause our stock price to fall.
We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders would likely experience substantial dilution. We may sell our common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell our common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales would likely also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders. Furthermore, we have filed a prospectus supplement related to the offer and sale of our common stock under the HCW Sales Agreement. As of November 11, 2026 and September 30, 2026, we had no capacity to issue shares of common stock under the prospectus supplement.
If we do not continue to satisfy the Nasdaq continued listing requirements, our securities could be delisted from the Nasdaq.
The listing of our common stock on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We were previously not in compliance with the Nasdaq listing requirements. Although we have regained compliance, a future failure to maintain compliance with the Nasdaq’s continued listing requirements could result in our being subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and security price may decrease and we may experience further difficulties in raising capital, which could materially affect our operations and financial results. Further, delisting from the Nasdaq could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers and employees and could also trigger various defaults under our financing arrangements and other outstanding agreements.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
During the three months ended September 30, 2026,
ITEM 6. EXHIBITS
|
Exhibit Number |
Exhibit Description |
|
3.1(1) |
Amended and Restated Certificate of Incorporation, as amended May 29, 2024 |
|
3.2(2) |
Amended and Restated Bylaws |
|
10.1* |
Lease amendment, dated September 3, 2026 between the Company and the Irvine Company LLC. |
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31.1* |
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2* |
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1** |
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2** |
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
101.INS |
Inline XBRL Instance Document |
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
104 |
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
|
* |
Filed herewith. |
|
** |
Furnished herewith. |
|
(1) |
Previously filed as Exhibit 3.1 to the Annual Report on Form 10-K filed by us on March 26, 2025. |
|
(2) |
Previously filed as Exhibit 3.1 to the Current Report on Form 8-K filed by us on May 1, 2023. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
BIOCARDIA, INC. |
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(Registrant) |
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Date: November 12, 2026 |
By: |
/s/ Peter Altman |
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|
Peter Altman |
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|
President and Chief Executive Officer |
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|
(Principal Executive Officer) |
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Date: November 12, 2026 |
By: |
/s/ David McClung |
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|
David McClung |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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