BioCardia Inc
For the period ended Dec 31, 2023. Filed Mar 27, 2024.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 27, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
| PART I | ||
|---|---|---|
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 28 |
| Item 1B. | Unresolved Staff Comments | 61 |
| Item 1C. | Cybersecurity | 61 |
| Item 2. | Properties | 62 |
| Item 3. | Legal Proceedings | 62 |
| Item 4. | Mine Safety Disclosures | 62 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 62 |
| Item 6. | Selected Financial Data | 63 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 63 |
| Item 7A. | Quantitative and Qualitative Disclosures about Market Risk | 71 |
| Item 8. | Financial Statements and Supplementary Data | 72 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 93 |
| Item 9A. | Controls and Procedures | 93 |
| Item 9B. | Other Information | 94 |
| Item 9C. | Disclosure Regarding Foreign Jurisdiction that Prevent Inspections | 94 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 95 |
| Item 11. | Executive Compensation | 101 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 105 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 108 |
| Item 14. | Principal Accounting Fees and Services | 109 |
| PART IV | ||
| Item 15. | Exhibits, Financial Statement Schedules | 110 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any and all statements contained in this Annual Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Those statements appear in this Annual Report, and include statements regarding the intent, belief or current expectations of the company and management that are subject to known and unknown risks, uncertainties and assumptions and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to those discussed in the section entitled “Risk Factors” in Item 1A of this Annual Report.
Forward-looking statements in this Annual Report may include, without limitation, statements regarding:
| (i) | expectations concerning our ability to raise additional funding from equity or debt financings and to continue as a going concern; |
| (ii) | our ability to retain the listing of our securities on the Nasdaq Capital Market; |
| (iii) | the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems; |
| (iv) | the timing and conduct of the clinical trials for our products, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials as well as our research and development programs; |
| (v) | the timing or likelihood of regulatory filing, approvals and required licenses for our cell therapy systems; |
| (vi) | our ability to adequately protect our intellectual property rights and enforce such rights to avoid violation of the intellectual property rights of others; |
| (vii) | the timing, costs and other aspects of the commercial launch of our products; |
| (viii) | our estimates regarding the market opportunity, clinical utility, potential advantages and market acceptance of our products; |
| (ix) | the impact of government laws and regulations; |
| (x) | our ability to recruit and retain qualified clinical, regulatory and research and development personnel; |
| (xi) | the availability of reimbursement or other forms of funding for our products from government and commercial payors; |
| (xii) | difficulties in maintaining commercial scale manufacturing capacity and capability and our ability to generate growth; |
| (xiii) | uncertainty in industry demand; |
| (xiv) | general economic conditions and market conditions in our industry; |
| (xv) | the effects of pandemics, such as COVID-19, on our business, preclinical studies and clinical trials; |
| (xvi) | the depth of the trading market in our securities; |
| (xvii) | a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; |
| (xviii) | 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 Securities and Exchange Commission (SEC); and |
| (xix) | the assumptions underlying or relating to any statement described in points (i)-(v) above. These statements are not guarantees of future performance and are subject to numerous risks, uncertainties, and assumptions that are difficult to predict. |
Except as required by applicable law, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.