BioCardia(BCDA)

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BioCardia(BCDA) - 2020 Q3 - Quarterly Report
2020-11-10 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) ...
BioCardia(BCDA) - 2020 Q2 - Quarterly Report
2020-08-13 10:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) (I.R ...
BioCardia(BCDA) - 2020 Q1 - Quarterly Report
2020-05-15 11:26
Part I. FINANCIAL INFORMATION [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2020 reflect a significant decline in cash, a shift to a stockholders' deficit, and a widening net loss, raising substantial doubt about going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2020, total assets significantly decreased to **$4.4 million**, leading to a **$1.3 million** stockholders' deficit from a prior equity position | Financial Metric | March 31, 2020 (unaudited, in thousands) | December 31, 2019 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,587 | $5,585 | | Total current assets | $3,219 | $6,378 | | Total assets | $4,384 | $7,678 | | **Liabilities & Equity** | | | | Total current liabilities | $4,510 | $4,003 | | Total liabilities | $5,667 | $5,308 | | Total stockholders' (deficit) equity | $(1,283) | $2,370 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2020, the company's net loss widened to **$4.6 million** from **$3.7 million** year-over-year, driven by sharply reduced revenue and increased operating expenses | Metric (in thousands) | Three months ended March 31, 2020 | Three months ended March 31, 2019 | | :--- | :--- | :--- | | Total revenue | $38 | $216 | | Research and development | $2,786 | $2,166 | | Selling, general and administrative | $1,857 | $1,631 | | Operating loss | $(4,609) | $(3,687) | | Net loss | $(4,594) | $(3,665) | | Net loss per share | $(0.67) | $(0.86) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity shifted from a **$2.4 million** positive balance to a **$1.3 million** deficit in Q1 2020, primarily due to the **$4.6 million** net loss - The company's equity position shifted from a positive balance of **$2,370 thousand** at the end of 2019 to a deficit of **$(1,283) thousand** by March 31, 2020, driven by the quarterly net loss of **$4,594 thousand**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$3.0 million** in Q1 2020, leading to a **$3.0 million** decrease in cash and equivalents, ending the quarter at **$2.6 million** | Cash Flow Activity (in thousands) | Three months ended March 31, 2020 | Three months ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,993) | $(2,465) | | Net cash used in investing activities | $(5) | $(55) | | Net cash provided by financing activities | $0 | $0 | | **Net change in cash** | **$(2,998)** | **$(2,520)** | | **Cash at end of period** | **$2,587** | **$2,838** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes describe the company's clinical-stage focus, express substantial doubt about its going concern due to insufficient cash, and detail impacts from COVID-19 and a subsequent PPP loan - The company is a clinical-stage regenerative medicine company focused on developing therapeutics for cardiovascular diseases, with its lead candidates being the CardiAMP® and CardiALLO™ cell therapy systems[19](index=19&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern beyond Q2 2020, as its cash of **$2.6 million** is insufficient to fund operations. The company plans to raise additional capital to continue development[27](index=27&type=chunk)[28](index=28&type=chunk) - On January 29, 2020, the company repriced **515,036** stock options, lowering the exercise price to **$5.32 per share**. This resulted in an incremental stock-based compensation expense of **$569,000**[56](index=56&type=chunk)[57](index=57&type=chunk) - On April 9, 2020, the company entered into a non-recourse Litigation Funding Agreement with an entity controlled by a board member to fund its legal proceedings against Boston Scientific Corp[65](index=65&type=chunk)[66](index=66&type=chunk) - Subsequent to the quarter end, on May 1, 2020, a subsidiary of the company received a loan of **$506,413** under the Paycheck Protection Program (PPP)[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage focus, highlights significant revenue decline and increased R&D, and discloses critical liquidity issues, including insufficient cash and a Nasdaq delisting notice - The company is advancing its CardiAMP cell therapy in a Phase III trial for heart failure (BCDA-01) and a pivotal trial for chronic myocardial ischemia (BCDA-02). It is also developing its allogeneic CardiALLO cell therapy for heart failure (BCDA-03) and intends to file an IND for its use in COVID-19 related ARDS (BCDA-04)[76](index=76&type=chunk)[80](index=80&type=chunk)[88](index=88&type=chunk) - The COVID-19 pandemic is impacting clinical trial enrollment, as elective procedures are being postponed at clinical centers. The company is taking steps to address protocol deviations in alignment with FDA guidance[83](index=83&type=chunk) - Revenue for Q1 2020 decreased to **$38,000** from **$216,000** in Q1 2019 due to lower commercial catheter sales and reduced partnering activities[101](index=101&type=chunk) - R&D expenses increased by **$620,000** in Q1 2020 compared to Q1 2019, driven by the CardiAMP Heart Failure Trial and development of the CardiALLO system[103](index=103&type=chunk) - The company's cash and cash equivalents of **$2.6 million** as of March 31, 2020, are not sufficient to fund operations beyond the second quarter of 2020, raising substantial doubt about its ability to continue as a going concern[114](index=114&type=chunk)[117](index=117&type=chunk) - On April 15, 2020, the company received a delisting notice from Nasdaq for failing to meet the minimum stockholders' equity requirement of **$2.5 million**[119](index=119&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is limited, primarily to short-term cash and equivalents, with insignificant interest rate or foreign currency exchange risk - Market risk is primarily limited to cash and cash equivalents, which have maturities of less than three months[126](index=126&type=chunk) - The company does not believe an increase in market interest rates would have a material negative impact on its portfolio value due to the short-term nature of its holdings[126](index=126&type=chunk)[128](index=128&type=chunk) - Exposure to foreign currency exchange risk is not significant, and the company does not currently use hedging instruments[129](index=129&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2020, due to a material weakness in internal control over financial reporting, with remediation underway - Management, including the CEO and CFO, concluded that disclosure controls and procedures were not effective as of March 31, 2020[130](index=130&type=chunk) - A material weakness persists from 2019, stemming from a lack of sufficient technical resources to account for complex non-routine transactions[131](index=131&type=chunk) - Remediation efforts include enhancing review processes for non-routine transactions and engaging external consultants for expertise[132](index=132&type=chunk) Part II. OTHER INFORMATION [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in a legal proceeding with Boston Scientific Corp. over intellectual property, alleging improper patent assignment and seeking damages, with litigation costs covered by a funding agreement - The company is engaged in litigation with Boston Scientific Corp. (Case No. 3:19-05645-VC) over a patent and patent applications filed by a former employee, Ms. Surbhi Sarna[136](index=136&type=chunk) - BioCardia filed a counterclaim against Boston Scientific and Ms. Sarna for breach of contract, misappropriation of trade secrets, and correction of inventorship[136](index=136&type=chunk) - To fund the litigation, the company entered into a Litigation Funding Agreement with BSLF, L.L.C., an entity controlled by board member Andrew Blank[136](index=136&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is the potential delisting from Nasdaq due to non-compliance with the minimum stockholders' equity requirement, which could negatively impact liquidity and capital raising - The company received a notice from Nasdaq on April 15, 2020, for being non-compliant with the **$2.5 million** minimum stockholders' equity requirement for continued listing[138](index=138&type=chunk)[139](index=139&type=chunk) - BioCardia has until June 1, 2020, to submit a plan to Nasdaq to regain compliance, and if accepted, may be granted an extension of up to **180 days**[139](index=139&type=chunk) - A potential delisting could negatively affect the stock's liquidity and price, investor confidence, and the company's ability to secure financing[140](index=140&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - None[142](index=142&type=chunk) [Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period - None[142](index=142&type=chunk) [Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[142](index=142&type=chunk) [Other Information](index=32&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - None[142](index=142&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including the Litigation Funding Agreement, PPP loan note, and officer certifications - Key exhibits filed include the Litigation Funding Agreement (10.1), the PPP loan note (10.2), and CEO/CFO certifications (31.1, 31.2, 32.1, 32.2)[143](index=143&type=chunk)
BioCardia(BCDA) - 2019 Q4 - Annual Report
2020-04-09 17:54
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________ _____________ Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 0-21419 BIOCARDIA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 23-2753988 (State or ...
BioCardia(BCDA) - 2019 Q3 - Quarterly Report
2019-11-19 21:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) ...
BioCardia(BCDA) - 2019 Q2 - Quarterly Report
2019-08-14 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) (I.R ...
BioCardia(BCDA) - 2019 Q1 - Quarterly Report
2019-05-15 19:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) (I. ...
BioCardia(BCDA) - 2018 Q4 - Annual Report
2019-04-02 01:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 0-21419 BIOCARDIA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 23-2753988 (State or Other Jurisdiction of Incorp ...