BioCardia, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>BioCardia, Inc. has filed its 2023 10-K, detailing its business operations, financial instruments, and recent corporate events.</b>

AI Summary

BioCardia, Inc. (BCDA) filed a Annual Report (10-K) with the SEC on March 27, 2024. BioCardia, Inc. filed its 2023 Form 10-K on March 27, 2024, reporting on its fiscal year ended December 31, 2023. The company previously operated under the names Tiger X Medical, Inc., Cardo Medical, Inc., and CLICKNSETTLE COM INC. BioCardia is involved in the biological products sector, specifically SIC code 2836. The filing details various financial instruments including warrants, restricted stock units, and employee stock options for the fiscal years 2022 and 2023. Subsequent events noted include a Securities Purchase and Registration Rights Agreement and the issuance of warrants in a private placement on February 9, 2024.

Why It Matters

For investors and stakeholders tracking BioCardia, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of BioCardia's financial health and operational status for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The disclosure of subsequent events, such as the February 9, 2024, Securities Purchase and Registration Rights Agreement, offers insights into recent financing activities and potential dilution or capital raising strategies.

Risk Assessment

Risk Level: medium — BioCardia, Inc. shows moderate risk based on this filing. The company's financial disclosures are limited in this extract, making it difficult to assess its overall financial health, revenue generation, or profitability, which are key indicators for investment risk.

Analyst Insight

Investors should review the full 10-K filing to understand BioCardia's financial statements, revenue streams, and any disclosed risks related to its business operations and product development.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-27 — Filing Date (Filed as of date)
• 2022 — Fiscal Year (Warrant and RSU data period)
• 2023 — Fiscal Year (Warrant and RSU data period)

Key Players & Entities

• BioCardia, Inc. (company) — Filer name
• Tiger X Medical, Inc. (company) — Former company name
• Cardo Medical, Inc. (company) — Former company name
• CLICKNSETTLE COM INC (company) — Former company name
• 2836 (other) — Standard Industrial Classification
• 2024-02-09 (date) — Subsequent event date

FAQ

Risk Factors

• Customer Concentration Risk [medium — financial]: The company faces risks related to customer concentration, as indicated by data for Customer One, Customer Two, and Customer Three in 2022.

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 10-K
• 2024-03-27: Filing Date — Date the 10-K was officially filed with the SEC
• 2024-02-09: Subsequent Event — Date of Securities Purchase and Registration Rights Agreement and warrant issuance

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the official annual financial and operational overview for BioCardia, Inc.)

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 Warrant to Purchase Common Stock BC
• $2.67 — by reference to the last sale price of $2.67 for the common stock on the Nasdaq Capi
• $30.7 billion — rt failure cost the nation an estimated $30.7 billion in 2012, including the cost of health c
• $69.8 billion — cost of heart failure will increase to $69.8 billion by 2030. During heart failure progress
• $20,000 — l Therapy System and procedure at up to $20,000 for both treatment and control, and cli

Filing Documents

• bcda20231231_10k.htm (10-K) — 1911KB
• ex_642178.htm (EX-21.1) — 2KB
• ex_642179.htm (EX-23.1) — 3KB
• ex_642180.htm (EX-31.1) — 8KB
• ex_642181.htm (EX-31.2) — 8KB
• ex_642182.htm (EX-32.1) — 4KB
• ex_642183.htm (EX-32.2) — 4KB
• ex_642184.htm (EX-97.1) — 37KB
• chart1.jpg (GRAPHIC) — 98KB
• 0001437749-24-009587.txt (&nbsp;) — 7253KB
• bcda-20231231.xsd (EX-101.SCH) — 61KB
• bcda-20231231_def.xml (EX-101.DEF) — 418KB
• bcda-20231231_lab.xml (EX-101.LAB) — 351KB
• bcda-20231231_pre.xml (EX-101.PRE) — 451KB
• bcda-20231231_cal.xml (EX-101.CAL) — 38KB
• bcda20231231_10k_htm.xml (XML) — 886KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 28 Item 1B. Unresolved Staff Comments 61 Item 1C. Cybersecurity 61 Item 2.

Properties

Properties 62 Item 3.

Legal Proceedings

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

Selected Financial Data 63 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 63 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 71 Item 8.

Financial Statements and Supplementary Data

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

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

Executive Compensation 101 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

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 3 Table of Contents 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

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

BUSINESS

PART I. BUSINESS Overview We are a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from the bone marrow in clinical trials today. Our CardiAMP autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an "off the shelf" cell therapy for two clinical indications: the treatment of ischemic HFrEF (CardiALLO), which is actively enrolling, and acute respiratory distress syndrome (ARDS). Our autologous CardiAMP and our allogeneic CardiALLO cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform and provide development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. Heart Failure Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2022, the American Heart Association, or AHA, report on heart disease statistics estimated that 6.0 million American adults ages 20 and older have heart failure based on data from 2015 to 2018 and the prevalence of heart failure is expected to increase by 46% from 2012 to 2030, affecting greater than 8 million people aged 18 and above. The total percentage of the population with HF is projected to rise from 2.4% in 2012 to 3.0% in 2030 with 47% of the effective population estimated to have HFrEF. The AHA has also estimated that heart failure cost the nation an estimated $30.7 billion in 2012, including the c

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View this 10-K filing on SEC EDGAR