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 ...

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)

[General Information](index=1&type=section&id=General%20Information) BioCardia, Inc., a Delaware-incorporated non-accelerated filer, filed its 2019 10-K, with common stock and warrants listed on Nasdaq - BioCardia, Inc. is a Delaware-incorporated company, filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2019[1](index=1&type=chunk) - The registrant is classified as a Non-accelerated filer and a Smaller reporting company[4](index=4&type=chunk) Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | |:--------------------------------|:------------------|:------------------------------------------| | Common Stock, par value $0.001 | BCDA | The Nasdaq Capital Market | | Warrant to Purchase Common Stock | BCDAW | The Nasdaq Capital Market | Market Value and Shares Outstanding (June 30, 2019 / March 20, 2020) | Metric | Value | |:--------------------------------------------------------------------|:---------------| | Aggregate market value of voting and non-voting common equity held by non-affiliates (June 30, 2019) | ~$23,226,531 | | Shares of Common Stock outstanding (March 20, 2020) | 6,848,355 | [Special Note Regarding Forward-Looking Statements](index=5&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements subject to risks and uncertainties, with no obligation to update except as legally required - This Annual Report contains forward-looking statements subject to known and unknown risks, uncertainties, and assumptions that could cause actual results to differ materially from future results expressed or implied[8](index=8&type=chunk) - Forward-looking statements include plans for future operations, timing and conduct of clinical trials, regulatory approvals, intellectual property protection, commercial launch, market opportunity, impact of government regulations, personnel recruitment, reimbursement, manufacturing capacity, industry demand, economic conditions, COVID-19 impact, trading market depth, and financial projections[9](index=9&type=chunk) - The company disclaims any obligation to update or revise any forward-looking statement, except as required by applicable law[10](index=10&type=chunk) [PART I](index=6&type=section&id=PART%20I) [ITEM 1. Business](index=6&type=section&id=ITEM%201.%20Business) BioCardia, Inc. is a clinical-stage regenerative medicine company focused on developing cell-based therapies for cardiovascular diseases, supported by proprietary delivery systems, aiming for FDA approval and commercialization while protecting its intellectual property - BioCardia is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases, focusing on autologous and allogeneic cell-based therapies[11](index=11&type=chunk) - The company's therapeutic portfolio includes the CardiAMP and CardiALLO cell therapies, which utilize proprietary therapeutic delivery products[11](index=11&type=chunk) [Overview](index=6&type=section&id=Overview) BioCardia is a clinical-stage regenerative medicine company developing CardiAMP and CardiALLO cell therapies for cardiovascular diseases - BioCardia is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases, specifically autologous and allogeneic cell-based therapies[11](index=11&type=chunk) - The lead therapeutic candidate is the investigational CardiAMP Cell Therapy System, an autologous bone marrow derived cell therapy for heart failure after a heart attack and chronic myocardial ischemia[12](index=12&type=chunk) - The second therapeutic candidate is the CardiALLO Cell Therapy System, an investigational culture expanded bone marrow derived allogenic 'off the shelf' cell therapy with potential for heart failure and other indications[13](index=13&type=chunk) [Market Overview](index=6&type=section&id=Market%20Overview) Bone marrow-derived cell therapy shows promise for heart failure and chronic myocardial ischemia, addressing significant unmet medical needs - Adult bone marrow contains stem and progenitor cells capable of differentiating into various cell types and promoting cardiac recovery through paracrine effects and immune modulation[15](index=15&type=chunk) - Bone marrow derived cell-based therapy has shown potential benefits for heart failure and chronic myocardial ischemia, including improved ventricular function, reduced dead heart tissue, increased blood flow, and reduced adverse events[17](index=17&type=chunk) - Heart failure affects an estimated **6.5 million American adults**, with a **50% mortality rate** at five years post-diagnosis[18](index=18&type=chunk)[19](index=19&type=chunk) - Approximately **1.2 million NYHA Class II and Class III ischemic systolic heart failure patients** are estimated to qualify for CardiAMP therapy[22](index=22&type=chunk) - Refractory angina, a condition of chronic myocardial ischemia, affects **600,000 to 1.8 million patients** in the U.S. annually, with **75,000 new cases**, representing a significant unmet need[23](index=23&type=chunk) [Our Product Candidates](index=7&type=section&id=Our%20Product%20Candidates) BioCardia's product candidates include CardiAMP and CardiALLO cell therapy systems, supported by Helix™ and Morph delivery systems - The CardiAMP Cell Therapy System is an investigational therapy for heart failure and chronic myocardial ischemia, comprising a cell potency screening test, a point-of-care cell processing platform, and a biotherapeutic delivery system[24](index=24&type=chunk) - The CardiALLO Cell Therapy System is an 'off the shelf' mesenchymal stem cell therapy derived from Neurokinin-1 receptor positive bone marrow cells, intended for ischemic systolic heart failure, particularly for patients with lower cell potency scores[40](index=40&type=chunk)[41](index=41&type=chunk) - The Helix™ Biotherapeutic Delivery System is a CE marked (Europe) and investigational (US) percutaneous catheter system designed for local delivery of cell and gene-based therapies into the heart muscle, enabling active fixation during delivery[43](index=43&type=chunk) - Morph Deflectable Guide and Sheaths Products are commercially available in the US and Europe, designed to navigate tortuous anatomy and support Helix procedures, with over **ten thousand patients treated**[45](index=45&type=chunk) [Business Strategy](index=12&type=section&id=Business%20Strategy) BioCardia aims to complete pivotal trials, obtain FDA approval, and commercialize CardiAMP and CardiALLO, while leveraging its delivery systems - BioCardia's business strategy includes completing Phase III pivotal trials for CardiAMP in heart failure and chronic myocardial ischemia, obtaining FDA approval, and commercializing CardiAMP using a targeted cardiology sales force[46](index=46&type=chunk)[47](index=47&type=chunk) - The company also aims to advance the CardiALLO Cell Therapy System for ischemic systolic heart failure, selectively partner its Helix™ delivery system, and continue commercializing Morph catheter products[48](index=48&type=chunk) [Intellectual Property](index=12&type=section&id=Intellectual%20Property) BioCardia protects its cell therapies and delivery systems with over 65 patents, seeking regulatory exclusivity and patent term extensions - BioCardia has a large patent portfolio with over **65 issued or pending U.S. and international patents** covering CardiAMP, CardiALLO, Helix™, and Morph products, with key US patents expiring between **2020 and 2034**[51](index=51&type=chunk) Recently Issued United States Patents | US Patent No. | Patent Title | Expiration on or after | |:--------------|:--------------------------------------------------------------------------|:-----------------------| | 10,520,505 | Methods of measuring therapeutic potency and defining dosages for autologous cell therapy | 2034 | | 10,071,226 | Radial and trans-endocardial delivery catheter | 2034 | | 10,035,982 | Method of preparing autologous cells and methods of use for therapy | 2029 | | 9,945,854 | Methods of measuring therapeutic potency potential and defining dosages for autologous cell therapy | 2034 | | 9,752,123 | Method of Preparing Autologous Cells and Methods of Use for Therapy | 2029 | | 9,517,199 | Treatment for chronic myocardial infarct | 2027 | | 9,504,642 | Treatment for chronic myocardial infarct | 2027 | | 9,301,975 | Method of preparing autologous cells and method of use for therapy | 2029 | | 8,496,926 | Treatment for chronic myocardial infarction | 2027 | - The company may receive **12-year regulatory exclusivity** for CardiAMP and CardiALLO under the Biologics Price Competition and Innovation Act, and potentially patent term extensions under the Hatch-Waxman Act[53](index=53&type=chunk)[54](index=54&type=chunk)[58](index=58&type=chunk) - BioCardia protects its proprietary technology through trade secrets, confidentiality agreements with employees and partners, and physical/electronic security measures[59](index=59&type=chunk) [Manufacturing](index=14&type=section&id=Manufacturing) CardiAMP cell processing is outsourced, CardiALLO cells are produced internally, and delivery systems are manufactured in-house with third-party components - The CardiAMP cell processing platform is manufactured by Biomet Biologics, LLC[60](index=60&type=chunk) - CardiALLO cells are produced in BioCardia's preclinical development tissue culture facility, with future clinical manufacturing planned in a new facility[60](index=60&type=chunk) - Helix™ biotherapeutic delivery system and Morph vascular access products are manufactured in BioCardia's San Carlos, California device manufacturing facility using third-party sourced components[60](index=60&type=chunk) [Sales and Marketing](index=14&type=section&id=Sales%20and%20Marketing) BioCardia plans a direct sales model for CardiAMP and CardiALLO, targeting cardiologists at high-volume U.S. hospitals - BioCardia plans to market CardiAMP and CardiALLO cell therapy systems, if approved, using a dedicated direct sales model targeting selected cardiologists at high-volume U.S. hospitals and medical centers[61](index=61&type=chunk) - The strategy relies on cardiologists' history of early adoption of innovative products and technologies due to sustained innovation and large unmet medical needs in heart failure patients[61](index=61&type=chunk) [Competition](index=14&type=section&id=Competition) BioCardia faces intense competition from larger pharmaceutical and biotech companies in the cell-based therapy market - BioCardia operates in a highly competitive biotechnology and pharmaceutical industry, facing competition from larger, better-funded companies and specialized firms in cell-based and gene-based therapeutic products for heart failure and chronic myocardial ischemia[62](index=62&type=chunk) - The company views other companies developing delivery platforms as potential collaborators due to the large clinical need and the potential for its biotherapeutic delivery products to enable multiple biotherapeutics[63](index=63&type=chunk) [License Agreement with Biomet Biologics, LLC](index=15&type=section&id=License%20Agreement%20with%20Biomet%20Biologics,%20LLC) BioCardia holds an exclusive license from Biomet Biologics for a point-of-care cell processing platform, paying low to mid-single digit royalties - In October 2012, BioCardia entered an exclusive, nontransferable, worldwide distribution right, patent license, and trademark license agreement with Biomet Biologics, LLC for a point-of-care cell processing platform[64](index=64&type=chunk) - Under the agreement, BioCardia pays a **low or mid-single digit percentage royalty** on the price of CardiAMP cell processing platform disposables, with the agreement term being **10 years** or until the last patent expires[64](index=64&type=chunk) [Technology Access Program for Biotherapeutic Delivery Systems](index=15&type=section&id=Technology%20Access%20Program%20for%20Biotherapeutic%20Delivery%20Systems) Preclinical partnerships provide BioCardia with data and non-exclusive licenses for delivery technology improvements - BioCardia's preclinical partnerships provide access to data, reports, and non-exclusive licenses for delivery technology improvement inventions[65](index=65&type=chunk) [Clinical Research Agreements for Biotherapeutic Delivery Systems](index=15&type=section&id=Clinical%20Research%20Agreements%20for%20Biotherapeutic%20Delivery%20Systems) Clinical partnerships grant BioCardia data access and non-exclusive licenses for technology improvements, with financial terms - Clinical partnerships grant BioCardia access to data, reports, and non-exclusive licenses for technology improvement inventions, with financial terms covering costs and milestone payments[66](index=66&type=chunk) [Government Regulation](index=15&type=section&id=Government%20Regulation) BioCardia's cell therapies and medical devices are subject to extensive FDA and international regulations, including approval, manufacturing, and reimbursement - Biological products and medical devices, including cell-based therapies, are subject to extensive regulation by the FDA and other federal, state, local, and foreign authorities, covering testing, manufacturing, safety, efficacy, labeling, and promotion[67](index=67&type=chunk) - The FDA's Center for Biologics Evaluation and Research (CBER) regulates cell-based therapies, collaborating with the Center for Devices and Radiological Health (CDRH) for products involving medical devices[68](index=68&type=chunk) - The U.S. biological product development and regulatory approval process involves preclinical testing (GLP), IND application, IRB approval, human clinical trials (GCP), BLA submission, FDA advisory committee review, manufacturing facility inspection (GMP), and FDA approval[69](index=69&type=chunk) - The FDA offers expedited programs like Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy Designation for serious or life-threatening conditions with unmet medical needs or substantial therapeutic improvement potential[90](index=90&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - Post-approval requirements include compliance with GMP, reporting adverse events, submitting new applications for changes, and adhering to advertising and promotion regulations[93](index=93&type=chunk) - The Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for biosimilar products, potentially increasing competition for BioCardia's CardiALLO[98](index=98&type=chunk) - Medical devices require either 510(k) clearance or Premarket Approval (PMA) from the FDA, with combination products like CardiAMP regulated through the PMA pathway by CBER[105](index=105&type=chunk)[107](index=107&type=chunk) - Companion diagnostics, such as the CardiAMP potency assay, are regulated as medical devices and require separate regulatory clearance or approval (PMA to CDRH) prior to commercial use, ideally co-developed with the biological product[117](index=117&type=chunk)[118](index=118&type=chunk) - Sales of products depend on coverage and reimbursement from third-party payors, which are increasingly reducing reimbursements and implementing cost containment programs, potentially limiting net revenue[119](index=119&type=chunk) - The Affordable Care Act (ACA) introduced measures impacting healthcare financing, including changes to Medicaid Drug Rebate Program, 340B drug pricing, Medicare Part D discounts, and an annual fee on branded drugs, which could affect BioCardia's sales and profitability[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) - BioCardia is subject to various federal and state fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Physician Payment Sunshine Act) and foreign regulations, which impact sales, marketing, and compliance efforts[128](index=128&type=chunk)[130](index=130&type=chunk)[134](index=134&type=chunk) - In Europe, CardiAMP and CardiALLO are expected to be regulated as Advanced Therapy Medicinal Products (ATMPs) under the ATMP Regulation, requiring marketing authorization from the EMA[140](index=140&type=chunk) [Employees](index=32&type=section&id=Employees) As of December 31, 2019, BioCardia had 24 employees and contractors, with future success dependent on attracting and retaining qualified personnel - As of December 31, 2019, BioCardia had **20 full-time and 4 part-time employees** across clinical development, product development, regulatory, manufacturing, quality, finance, administration, sales, and marketing[146](index=146&type=chunk) - The company also uses independent contractors and considers relations with employees to be good, with future success dependent on attracting and retaining qualified personnel[146](index=146&type=chunk) [Corporate Information](index=32&type=section&id=Corporate%20Information) BioCardia, Inc., incorporated in Delaware in 1994, operates as a single segment focused on regenerative medicine for cardiovascular diseases - BioCardia, Inc. was originally incorporated in Delaware on January 12, 1994, and changed its name in October 2016 following a reverse merger[147](index=147&type=chunk) - The company operates as a single business segment: a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases[148](index=148&type=chunk) [ITEM 1A. Risk Factors](index=33&type=section&id=ITEM%201A.%20Risk%20Factors) Investing in BioCardia's securities involves significant risks, including the need for substantial additional financing to continue operations and clinical trials, a history of operating losses, and uncertainty about achieving profitability. The company's success heavily relies on obtaining regulatory approval and commercializing its novel cell therapy systems, which face challenges such as unpredictable development timelines, difficulties in patient enrollment, reliance on third-party manufacturers and CROs, intense competition, and ongoing regulatory scrutiny. Furthermore, the company is exposed to risks related to intellectual property protection, potential product liability, system failures, natural disasters, and the adverse impact of the COVID-19 pandemic on its business and clinical activities. The market price of its common stock is volatile, and significant ownership by principal stockholders could influence corporate decisions - BioCardia will require additional financing in 2020 to continue its Phase III pivotal trials for CardiAMP Cell Therapy System and maintain current operations, as current cash resources are insufficient beyond Q2 2020[152](index=152&type=chunk)[153](index=153&type=chunk) - The company has a history of operating losses, with a net loss of **$14.7 million** in 2019 and an accumulated deficit of **$101.1 million**, raising substantial doubt about its ability to continue as a going concern[154](index=154&type=chunk)[155](index=155&type=chunk)[158](index=158&type=chunk) - Success is largely dependent on obtaining approval for and commercializing the CardiAMP Cell Therapy System, which is based on novel technology and faces uncertainty in the FDA approval process, including the possibility of requiring more than one pivotal trial[160](index=160&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) - Difficulties in patient enrollment for clinical trials, due to factors like patient concerns about control arms or competitive trials, could significantly delay or terminate product development[176](index=176&type=chunk)[177](index=177&type=chunk) - Reliance on third parties for manufacturing, diagnostic protocol development, research, and clinical testing exposes BioCardia to risks of unsatisfactory performance, delays, or termination of agreements[183](index=183&type=chunk)[184](index=184&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk) - The biotechnology and pharmaceutical industries are highly competitive, with many competitors possessing greater resources, potentially leading to others developing or commercializing products more successfully[209](index=209&type=chunk) - Even if approved, products will be subject to ongoing regulatory scrutiny, including restrictions on use, post-approval studies, and compliance with manufacturing and promotional regulations, with non-compliance leading to severe sanctions[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) - The company's ability to compete depends on demonstrating CardiAMP's benefits (efficacy, cost-effectiveness) to physicians, hospitals, and patients, which may be challenging given limited market knowledge of cell-based therapies[199](index=199&type=chunk)[215](index=215&type=chunk) - Failure to adequately protect intellectual property (patents, trade secrets) could allow competitors to develop generic products or use proprietary information, harming BioCardia's competitive position[305](index=305&type=chunk)[307](index=307&type=chunk)[311](index=311&type=chunk) - The outbreak of COVID-19 could adversely impact business operations, preclinical studies, and clinical trials through delays in patient enrollment, clinical site initiation, supply chain disruptions, and limitations on employee resources[299](index=299&type=chunk)[301](index=301&type=chunk) - Principal stockholders and management own approximately **69.8% of voting stock**, enabling them to exert significant control over matters requiring stockholder approval[334](index=334&type=chunk) - A material weakness in internal control over financial reporting related to insufficient technical resources for complex non-routine transactions was identified and remains unremediated, potentially affecting financial reporting accuracy and investor confidence[337](index=337&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk) [ITEM 1B. Unresolved Staff Comments](index=51&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) BioCardia, Inc. reported that there were no unresolved staff comments from the SEC - There are no unresolved staff comments[357](index=357&type=chunk) [ITEM 2. Properties](index=51&type=section&id=ITEM%202.%20Properties) BioCardia's principal executive office, lab, and manufacturing space are located in a 13,718 square foot leased facility in San Carlos, California, with the lease expiring in 2021. The company believes current facilities are adequate and future needs can be met on commercially reasonable terms - BioCardia's principal executive office, lab, and manufacturing space are located in a **13,718 square foot leased facility** at 125 Shoreway Road, Suite B, San Carlos, CA 94070[358](index=358&type=chunk) - The lease for this facility expires in **2021**, and the company believes its existing facilities are adequate for current needs, with sufficient options available for future expansion[358](index=358&type=chunk) [ITEM 3. Legal Proceedings](index=51&type=section&id=ITEM%203.%20Legal%20Proceedings) BioCardia is involved in a legal dispute over patent ownership with a former employee and Boston Scientific, seeking constructive trusts and damages - BioCardia initiated a legal dispute in 2019 against former employee Ms. Surbhi Sarna, nVision Medical, and Boston Scientific, alleging that Ms. Sarna assigned patents and applications, rightfully belonging to BioCardia, to her company, nVision Medical[360](index=360&type=chunk) - BioCardia filed a counterclaim in federal court for breach of contract, misappropriation of trade secrets, and correction of inventorship, seeking constructive trusts on the patents and proceeds from nVision's sale to Boston Scientific, along with damages[362](index=362&type=chunk) - Management currently does not expect these proceedings to have a material adverse effect on the company's business, financial position, results of operations, or cash flows[359](index=359&type=chunk) [ITEM 4. Mine Safety Disclosures](index=52&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) BioCardia, Inc. states that this item is not applicable to its operations - This item is not applicable[363](index=363&type=chunk) [PART II](index=53&type=section&id=PART%20II) [ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=53&type=section&id=ITEM%205.%20Market%20for%20Registrant%27s%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) BioCardia's common stock and warrants trade on Nasdaq, with no cash dividends paid or anticipated, and no unregistered sales or issuer repurchases - BioCardia's common stock and warrants trade on the Nasdaq Capital Market under the symbols 'BCDA' and 'BCDAW'[365](index=365&type=chunk) - As of December 31, 2019, there were approximately **201 holders of record** of the company's common stock[365](index=365&type=chunk) - The company has never declared or paid any cash dividends on its capital stock and intends to retain future earnings for business development, not expecting to pay dividends in the foreseeable future[366](index=366&type=chunk) - No unregistered securities were sold during the period covered by this Annual Report, and there were no issuer purchases of equity securities[367](index=367&type=chunk)[368](index=368&type=chunk) [ITEM 6. Selected Financial Data](index=53&type=section&id=ITEM%206.%20Selected%20Financial%20Data) BioCardia, Inc. has omitted selected financial data as permitted for smaller reporting companies - This item is not applicable, as the company has elected to omit certain information as a 'smaller reporting company'[368](index=368&type=chunk)[369](index=369&type=chunk) [ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=54&type=section&id=ITEM%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) BioCardia continues to incur significant losses, totaling $14.7 million in 2019, raising going concern doubts, with revenue growth driven by collaborations and increasing R&D expenses - BioCardia is a clinical-stage regenerative medicine company focused on developing CardiAMP and CardiALLO Cell Therapy Systems for cardiovascular diseases[370](index=370&type=chunk)[371](index=371&type=chunk) - The company has incurred net losses of **$14.7 million** in 2019, **$14.0 million** in 2018, and **$12.3 million** in 2017, with an accumulated deficit of **$101.1 million** as of December 31, 2019[384](index=384&type=chunk) - Current cash and cash equivalents of **$5.6 million** as of December 31, 2019, are not sufficient to fund operations beyond the **second quarter of 2020**, indicating substantial doubt about the company's ability to continue as a going concern[384](index=384&type=chunk)[409](index=409&type=chunk) - The CardiAMP Heart Failure Trial, a Phase III study, is ongoing with **74 patients enrolled at 25 sites**, and a second Phase III pivotal trial for CardiAMP in chronic myocardial ischemia is planned, both impacted by COVID-19[373](index=373&type=chunk)[374](index=374&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) - The CardiALLO Cell Therapy System, an 'off the shelf' mesenchymal cell therapy, is being advanced for ischemic systolic heart failure, with an IND application for a Phase I/II trial targeted for Q2 2020[380](index=380&type=chunk) Summary of Results of Operations (in thousands) | Metric | 2019 | 2018 | |:---------------------------------------------------------------------|:----------|:----------| | Net product revenue | $182 | $282 | | Collaboration agreement revenue | $528 | $343 | | **Total revenue** | **$710** | **$625** | | Cost of goods sold | $358 | $517 | | Research and development | $8,562 | $8,453 | | Selling, general and administrative | $6,003 | $5,757 | | **Total costs and expenses** | **$14,923** | **$14,727** | | **Operating loss** | **($14,213)** | **($14,102)** | | Interest income | $87 | $118 | | Gain on change in fair value of redemption feature embedded in convertible notes | $52 | — | | Interest expense | ($112) | — | | Loss on extinguishment of convertible notes | ($521) | — | | Other expense | ($2) | ($3) | | **Total other income (expense)** | **($496)** | **$115** | | **Net loss** | **($14,709)** | **($13,987)** | - Revenue increased by **$85,000** in 2019 compared to 2018, driven by higher collaboration agreement revenues offsetting decreased net product revenues[399](index=399&type=chunk) - Research and development expenses increased by **$100,000** in 2019, primarily due to the CardiAMP Heart Failure Trial and CardiALLO development, and are expected to increase moderately in the future[401](index=401&type=chunk) - Selling, general and administrative expenses increased by **$200,000** in 2019 due to stock-based compensation and corporate expenses, but are expected to decrease modestly in 2020[402](index=402&type=chunk) Summary of Cash Flows (in thousands) | Metric | 2019 | 2018 | |:--------------------------------------------|:----------|:----------| | Net cash provided by (used in): | | | | Operating activities | ($9,445) | ($11,069) | | Investing activities | ($146) | ($66) | | Financing activities | $9,818 | $3,804 | | Net increase (decrease) in cash and cash equivalents | $227 | ($7,331) | - Cash used in operating activities decreased by **$1.6 million** in 2019, primarily due to increases in noncurrent customer deposits, deferred revenue, and deferred board cash compensation[405](index=405&type=chunk) - Net cash provided by financing activities increased to **$9.8 million** in 2019 from **$3.8 million** in 2018, mainly from the sale of common stock and related warrants[406](index=406&type=chunk) [ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk](index=61&type=section&id=ITEM%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) BioCardia believes its operations are not significantly impacted by market interest rates or foreign exchange risk, managing accounts receivable internally - BioCardia does not expect its operating results or cash flows to be significantly affected by sudden changes in market interest rates or credit conditions[415](index=415&type=chunk) - The company manages accounts receivable risk through periodic reviews and appropriate allowances and is not exposed to foreign exchange risk, as it operates primarily in the United States and does not use hedging or derivative instruments[416](index=416&type=chunk) [ITEM 8. Financial Statements and Supplementary Data](index=61&type=section&id=ITEM%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents BioCardia's audited financial statements, including an unqualified opinion with a going concern emphasis, and details accounting policies - The independent registered public accounting firm issued an unqualified opinion on the consolidated financial statements but noted substantial doubt about BioCardia's ability to continue as a going concern due to net losses and negative cash flows since inception[419](index=419&type=chunk)[420](index=420&type=chunk) - The company changed its method of accounting for leases as of January 1, 2019, due to the adoption of FASB Accounting Standards Update 2016-02 and 2018-11[421](index=421&type=chunk) [Report of Independent Registered Public Accounting Firm](index=62&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor issued an unqualified opinion but highlighted substantial doubt about BioCardia's ability to continue as a going concern - The independent registered public accounting firm provided an unqualified opinion on BioCardia's consolidated financial statements for the years ended December 31, 2019, 2018, and 2017[419](index=419&type=chunk) - The report highlights a 'Going Concern' matter, noting the company's history of net losses and negative cash flows, which raises substantial doubt about its ability to continue as a going concern[420](index=420&type=chunk) - A change in accounting principle for leases was adopted as of January 1, 2019, due to FASB Accounting Standards Update 2016-02 and 2018-11[421](index=421&type=chunk) [Consolidated Balance Sheets](index=63&type=section&id=Consolidated%20Balance%20Sheets) This section presents BioCardia's consolidated balance sheets, detailing assets, liabilities, and stockholders' equity for 2019 and 2018 Consolidated Balance Sheet Data (in thousands) | Metric | December 31, 2019 | December 31, 2018 | |:----------------------------------------|:------------------|:------------------| | **Assets:** | | | | Cash and cash equivalents | $5,585 | $5,358 | | Accounts receivable, net | $147 | $274 | | Inventory | $4 | $141 | | Prepaid expenses and other current assets | $642 | $445 | | Total current assets | $6,378 | $6,218 | | Property and equipment, net | $181 | $145 | | Operating lease right-of-use asset, net | $1,065 | — | | Other assets | $54 | $54 | | **Total assets** | **$7,678** | **$6,417** | | **Liabilities:** | | | | Accounts payable | $914 | $743 | | Accrued expenses and other current liabilities | $2,561 | $1,805 | | Operating lease liability - current | $528 | — | | Total current liabilities | $4,003 | $2,548 | | Operating lease liability - noncurrent | $614 | — | | Deferred revenue | $691 | — | | Deferred rent | — | $77 | | **Total liabilities** | **$5,308** | **$2,625** | | **Stockholders' Equity:** | | | | Common stock | $7 | $5 | | Additional paid-in capital | $103,433 | $90,148 | | Accumulated deficit | ($101,070) | ($86,361) | | **Total stockholders' equity** | **$2,370** | **$3,792** | | **Total liabilities and stockholders' equity** | **$7,678** | **$6,417** | [Consolidated Statements of Operations](index=64&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents BioCardia's consolidated statements of operations, detailing revenues, expenses, and net losses for 2017-2019 Consolidated Statements of Operations Data (in thousands, except per share amounts) | Metric | 2019 | 2018 | 2017 | |:--------------------------------------------------------------------|:------------|:------------|:------------| | Net product revenue | $182 | $282 | $389 | | Collaboration agreement revenue | $528 | $343 | $90 | | **Total revenue** | **$710** | **$625** | **$479** | | Cost of goods sold | $358 | $517 | $690 | | Research and development | $8,562 | $8,453 | $5,799 | | Selling, general and administrative | $6,003 | $5,757 | $6,395 | | **Total costs and expenses** | **$14,923** | **$14,727** | **$12,884** | | **Operating loss** | **($14,213)** | **($14,102)** | **($12,405)** | | Interest income | $87 | $118 | $95 | | Gain on change in fair value of redemption feature embedded in convertible notes | $52 | — | — | | Interest expense | ($112) | — | — | | Loss on extinguishment of convertible notes | ($521) | — | — | | Other expense | ($2) | ($3) | $2 | | **Total other income (expense)** | **($496)** | **$115** | **$97** | | **Net loss** | **($14,709)** | **($13,987)** | **($12,308)** | | Net loss per share, basic and diluted | ($2.61) | ($3.28) | ($2.90) | | Weighted-average shares used in computing net loss per share, basic and diluted | 5,644,328 | 4,264,178 | 4,240,060 | [Consolidated Statements of Stockholders' Equity](index=65&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section presents BioCardia's consolidated statements of stockholders' equity, detailing changes from 2016 to 2019 Consolidated Statements of Stockholders' Equity (in thousands, except share data) | Metric | Common Stock Shares | Common Stock $ | Additional Paid-in Capital $ | Accumulated Deficit $ | Total $ | |:--------------------------------------------------------------------|:--------------------|:---------------|:-----------------------------|:----------------------|:--------| | Balance at December 31, 2016 | 4,236,813 | 4 | 80,720 | (60,142) | 20,582 | | Exercise of stock options | 9,706 | — | 144 | — | 144 | | Share-based compensation | — | — | 2,707 | — | 2,707 | | Net loss | — | — | — | (12,308) | (12,308)| | **Balance at December 31, 2017** | **4,246,519** | **4** | **83,571** | **(72,450)** | **11,125**| | Adjustments to opening balance for change in accounting principle | — | — | — | 76 | 76 | | Sale of common stock and warrants, net of issuance costs of $200 | 592,597 | 1 | 3,799 | — | 3,800 | | Restricted stock units vested and issued | 6,344 | — | — | — | — | | Exercise of stock options | 237 | — | 4 | — | 4 | | Share-based compensation | — | — | 2,774 | — | 2,774 | | Net loss | — | — | — | (13,987) | (13,987)| | **Balance at December 31, 2018** | **4,845,697** | **5** | **90,148** | **(86,361)** | **3,792**| | Reverse stock split fractional share true up | (494) | — | — | — | — | | Restricted stock units vested and issued | 27,426 | — | — | — | — | | Issuance of sale of stock and warrants, net of issuance costs of $1,259 | 1,741,667 | 2 | 9,194 | — | 9,196 | | Issuance of stock and warrants from conversion of convertible notes | 210,887 | — | 1,204 | — | 1,204 | | Issuance of restricted stock units in lieu of 2018 cash bonus | — | — | 165 | — | 165 | | Share-based compensation | — | — | 2,722 | — | 2,722 | | Net loss | — | — | — | (14,709) | (14,709)| | **Balance at December 31, 2019** | **6,825,183** | **7** | **103,433** | **(101,070)** | **2,370**| [Consolidated Statements of Cash Flows](index=66&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section presents BioCardia's consolidated statements of cash flows, detailing operating, investing, and financing activities for 2017-2019 Consolidated Statements of Cash Flows (in thousands) | Metric | 2019 | 2018 | 2017 | |:--------------------------------------------------------------------|:----------|:----------|:----------| | **Operating activities:** | | | | | Net loss | ($14,709) | ($13,987) | ($12,308) | | Adjustments to reconcile net loss to net cash used in operating activities: | | | | | Write-off of inventory | 1 | — | — | | Depreciation | 111 | 88 | 78 | | Reduction in the carrying amount of right-of-use assets | 440 | — | — | | Gain on change in fair value of redemption feature embedded in convertible notes | ($52) | — | — | | Loss on extinguishment of convertible notes | 521 | — | — | | Non-cash interest expense on convertible shareholder notes | 112 | — | — | | Share-based compensation | 2,722 | 2,774 | 2,707 | | Changes in operating assets and liabilities: | | | | | Accounts receivable | 127 | ($179) | ($21) | | Inventory | 136 | 49 | ($56) | | Prepaid expenses and other current assets | ($198) | ($104) | 16 | | Accounts payable | 171 | 119 | 377 | | Accrued liabilities excluding accrued interest on convertible note | 922 | 240 | 415 | | Operating lease liability - current | 88 | — | — | | Deferred revenue | 691 | ($65) | 96 | | Operating lease liability - noncurrent | ($528) | — | — | | Deferred rent | — | ($4) | 25 | | **Net cash used in operating activities** | **($9,445)**| **($11,069)** | **($8,671)**| | **Investing activities:** | | | | | Purchase of property and equipment | ($146) | ($66) | ($136) | | Purchase of short-term investments | — | — | ($1,800) | | Maturity of short-term investments | — | — | 1,800 | | **Net cash used in investing activities** | **($146)** | **($66)** | **($136)** | | **Financing activities:** | | | | | Proceeds from sale of common stock and warrants | 10,452 | 4,000 | — | | Issuance costs from sales of common stock and warrants | ($1,259) | ($200) | — | | Proceeds from convertible loan payable | 625 | — | — | | Proceeds from the exercise of common stock options | — | 4 | 144 | | **Net cash provided by financing activities** | **$9,818** | **$3,804** | **$144** | | **Net change in cash and cash equivalents** | **$227** | **($7,331)**| **($8,663)**| | Cash and cash equivalents at beginning of period | 5,358 | 12,689 | 21,352 | | **Cash and cash equivalents at end of period** | **$5,585** | **$5,358** | **$12,689** | | Supplemental disclosure for noncash investing and financing activities: | | | | | Conversion of notes and interest payable to stock and warrants | $633 | — | — | | Issuance of restricted stock units in lieu of 2018 cash bonus | $165 | — | — | | Right-of-use asset obtained in exchange for lease obligation | $1,505 | — | — | [Notes to Consolidated Financial Statements](index=67&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed notes to BioCardia's consolidated financial statements, covering business summary, accounting policies, and various financial disclosures [(1) Summary of Business](index=67&type=section&id=(1)%20Summary%20of%20Business) BioCardia, Inc. is a clinical-stage regenerative medicine company focused on developing cell therapy systems for cardiovascular diseases - BioCardia, Inc. is a clinical-stage regenerative medicine company developing CardiAMP and CardiALLO cell therapy systems for cardiovascular diseases[433](index=433&type=chunk) - The company's operations are managed as a single segment, focusing on research and development, clinical trials, manufacturing, sales capabilities, and intellectual property protection[433](index=433&type=chunk)[434](index=434&type=chunk) [(2) Significant Accounting Policies](index=67&type=section&id=(2)%20Significant%20Accounting%20Policies) BioCardia's financial statements adhere to U.S. GAAP, with significant estimates for assets, clinical accruals, and share-based compensation, and a going concern warning - The financial statements are prepared in accordance with U.S. GAAP and include consolidated accounts of the company and its wholly-owned subsidiary[435](index=435&type=chunk) - The company has incurred net losses and negative cash flows since inception, with an accumulated deficit of **$101.1 million** as of December 31, 2019, raising substantial doubt about its ability to continue as a going concern beyond Q2 2020 without additional funding[436](index=436&type=chunk)[437](index=437&type=chunk) - Significant estimates and assumptions are made for financial reporting, including useful lives of assets, inventory valuation, clinical accruals, and share-based compensation[438](index=438&type=chunk) - Revenue from product sales is recognized upon shipment, while collaboration agreement revenue is recognized over time based on progress towards satisfying performance obligations[455](index=455&type=chunk)[456](index=456&type=chunk)[459](index=459&type=chunk) - Research and development costs, including clinical trial expenses, are expensed as incurred[468](index=468&type=chunk) - Share-based compensation expense for equity awards is measured at fair value on the grant date and recognized over the vesting period[470](index=470&type=chunk) - The company adopted new lease accounting standards (ASU 2016-02 and 2018-11) on January 1, 2019, recognizing ROU assets of **$1,505,000** and lease liabilities of **$1,593,000** for operating leases[481](index=481&type=chunk)[484](index=484&type=chunk) - ASU 2018-07, improving nonemployee share-based payment accounting, was adopted on January 1, 2019, aligning accounting for nonemployee and employee awards[485](index=485&type=chunk)[486](index=486&type=chunk) [(3) Fair Value Measurements](index=75&type=section&id=(3)%20Fair%20Value%20Measurements) BioCardia applies fair value accounting, primarily using Level 1 inputs for money market funds, as detailed in its financial assets - BioCardia applies fair value accounting, prioritizing inputs into Level 1 (quoted prices in active markets), Level 2 (observable inputs), and Level 3 (unobservable inputs)[495](index=495&type=chunk) Fair Value of Financial Assets (in thousands) | Assets | December 31, 2019 | |:---------------------|:------------------| | Money market funds | $4,637 | | **Total** | **$4,637** | | Assets | December 31, 2018 | |:---------------------|:------------------| | Money market funds | $5,358 | | **Total** | **$5,358** | - The fair value of money market funds is determined based on Level 1 inputs (quoted prices in active markets)[497](index=497&type=chunk) [(4) Inventories](index=75&type=section&id=(4)%20Inventories) Inventories are valued at the lower of cost or net realizable value using the average-cost method, with write-downs for excess or expired items - Inventories are stated at the lower of cost or net realizable value using the average-cost method[498](index=498&type=chunk) Inventory Composition (in thousands) | Category | 2019 | 2018 | |:------------------|:-----|:-----| | Raw materials | $— | $79 | | Work in process | $— | $39 | | Finished goods | $4 | $23 | | **Total** | **$4** | **$141** | - Write-downs for excess or expired inventory, included in cost of goods sold, totaled **$36,000** in 2019, **$12,000** in 2018, and **$33,000** in 2017[500](index=500&type=chunk) [(5) Property and Equipment, Net](index=76&type=section&id=(5)%20Property%20and%20Equipment,%20Net) Property and equipment are recorded at cost less accumulated depreciation, calculated using the straight-line method over their useful lives - Property and equipment are carried at cost less accumulated depreciation, calculated using the straight-line method over estimated useful lives[501](index=501&type=chunk) Property and Equipment, Net (in thousands) | Category | 2019 | 2018 | |:-------------------------------------|:-------|:-------| | Computer equipment and software | $132 | $119 | | Laboratory and manufacturing equipment | $550 | $481 | | Furniture and fixtures | $55 | $55 | | Leasehold improvements | $332 | $332 | | Construction in progress | $69 | $3 | | Property and equipment, gross | $1,138 | $990 | | Less accumulated depreciation | ($957) | ($845) | | **Property and equipment, net** | **$181** | **$145** | - Depreciation expense was **$111,000** in 2019, **$88,000** in 2018, and **$78,000** in 2017[501](index=501&type=chunk) [(6) Lease](index=76&type=section&id=(6)%20Lease) BioCardia adopted new lease accounting standards in 2019, recognizing right-of-use assets and lease liabilities for its operating leases - BioCardia adopted the new lease standard on January 1, 2019, recognizing ROU assets and lease liabilities for operating leases, primarily for its laboratory and corporate offices[502](index=502&type=chunk)[503](index=503&type=chunk) Lease Expense and Terms (2019) | Metric | 2019 | |:----------------------------------------|:-----------| | Straight-line rent expense | $601,000 | | Variable rent expense | $264,000 | | **Total rent expense** | **$865,000** | | Weighted average remaining lease term | 2.0 years | | Weighted average discount rate | 12.05% | Future Minimum Lease Payments (in thousands) | Year | Undiscounted Lease Payments | |:-----|:----------------------------| | 2020 | $630 | | 2021 | $649 | | **Total undiscounted lease payments** | **$1,279** | | Less imputed interest | $137 | | **Total operating lease liabilities** | **$1,142** | [(7) Collaborative Agreements](index=77&type=section&id=(7)%20Collaborative%20Agreements) BioCardia engages in collaborations for its biotherapeutic delivery systems, receiving fees and data access while granting nonexclusive patent rights - BioCardia enters collaborations allowing partners to use its biotherapeutic delivery systems, training, and support for clinical and preclinical studies[509](index=509&type=chunk) - Under these agreements, the company receives use fees and payments for systems and services, gaining access to partner-generated data and nonexclusive patent rights for technology improvements[509](index=509&type=chunk) [(8) Accrued Expenses and Other Current Liabilities](index=78&type=section&id=(8)%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This section details BioCardia's accrued expenses and other current liabilities, including salaries, director compensation, and clinical trial costs Accrued Expenses and Other Current Liabilities (in thousands) | Category | 2019 | 2018 | |:-----------------------------------|:-------|:-------| | Accrued expenses | $10 | $127 | | Accrued salaries and employee benefits | $652 | $368 | | Accrued director compensation | $648 | $277 | | Accrued clinical trial costs | $519 | $276 | | Grant liability | $630 | $645 | | Customer deposits | $102 | $112 | | **Total** | **$2,561** | **$1,805** | [(9) Stockholders' Equity](index=78&type=section&id=(9)%20Stockholders%27%20Equity) BioCardia completed a public offering and convertible note financing in 2019, resulting in increased common stock and warrants, following a reverse stock split - In August 2019, BioCardia completed a public offering of **1,666,667 units** (common stock and warrants) at **$6.00 per unit**, generating approximately **$8.84 million** in net proceeds, and subsequently exercised an over-allotment for an additional **$420,000**[512](index=512&type=chunk) - The company's common stock and warrants began trading on the Nasdaq Capital Market on August 2, 2019[513](index=513&type=chunk) - In July 2019, BioCardia issued **$625,000** in convertible promissory notes, which automatically converted into **210,887 units** (common stock and warrants) at a **50% discount** to the public offering price upon the closing of the public offering[514](index=514&type=chunk)[515](index=515&type=chunk) - A **1-for-9 reverse stock split** was effected on June 6, 2019, retroactively adjusting all share and per share amounts[516](index=516&type=chunk) Warrant Activity (in thousands, except per warrant price) | Metric | Number of Common Stock Warrants | Weighted Average Exercise Price ($) | |:--------------------------------------|:--------------------------------|:------------------------------------| | Balance, December 31, 2018 | 296,296 | 6.75 | | Warrants for common stock sold | 2,139,512 | 6.30 | | Warrants for common stock exercised | — | — | | **Balance, December 31, 2019** | **2,435,808** | **6.36** | [(10) Share-Based Compensation](index=79&type=section&id=(10)%20Share-Based%20Compensation) BioCardia expenses the fair value of stock options and equity awards over their vesting periods, with significant unrecognized compensation remaining - BioCardia recognizes grant-date fair value of stock options and other equity-based compensation as expense over the vesting period[521](index=521&type=chunk) Share-Based Compensation Expense (in thousands) | Category | 2019 | 2018 | 2017 | |:----------------------------------------|:-------|:-------|:-------| | Cost of goods sold | $191 | $143 | $140 | | Research and development | $1,115 | $953 | $678 | | Selling, general and administrative | $1,416 | $1,678 | $1,889 | | **Share-based compensation expense** | **$2,722** | **$2,774** | **$2,707** | Stock Option Activity (in thousands, except share and per share amounts) | Metric | Number of shares | Weighted average exercise price ($) | |:----------------------------------------|:-----------------|:------------------------------------| | Balance, December 31, 2018 | 608,547 | 25.20 | | Stock options granted | 254,785 | 5.28 | | Stock options exercised | — | — | | Stock options canceled | (41,868) | 26.86 | | **Balance, December 31, 2019** | **821,464** | **18.99** | | Exercisable and vested, December 31, 2019 | 428,793 | 23.62 | - Unrecognized share-based compensation for options was approximately **$3.4 million** as of December 31, 2019, to be recognized over a remaining weighted average service period of **2.1 years**[524](index=524&type=chunk) - **34,713 restricted stock units (RSUs)** were granted to management in 2019 in lieu of bonuses, with an unrecognized compensation of **$171,000** to be recognized over **0.1 year**[525](index=525&type=chunk)[527](index=527&type=chunk) [(11) Concentrations](index=81&type=section&id=(11)%20Concentrations) BioCardia's revenue and accounts receivable are concentrated with a few key customers, primarily within the United States - Most of BioCardia's customers are in the United States[530](index=530&type=chunk) - In 2019, **two customers accounted for 43% and 25% of total revenues**, respectively[530](index=530&type=chunk) - One customer accounted for **15% of accounts receivable** at December 31, 2019, and **23%** at December 31, 2018[530](index=530&type=chunk) [(12) Net Loss per Share](index=82&type=section&id=(12)%20Net%20Loss%20per%20Share) BioCardia reports basic and diluted net loss per share, with no difference due to the antidilutive effect of potential common stock equivalents Net Loss per Share (in thousands, except share and per share data) | Metric | 2019 | 2018 | 2017 | |:--------------------------------------------------------------------|:------------|:------------|:------------| | Net loss | ($14,709) | ($13,987) | ($12,308) | | Weighted average shares used to compute net loss per share, basic and diluted | 5,644,328 | 4,264,178 | 4,240,060 | | **Net loss per share, basic and diluted** | **($2.61)** | **($3.28)** | **($2.90)** | Antidilutive Common Stock Equivalents Excluded from Diluted EPS | Category | 2019 | 2018 | 2017 | |:---------------------------------------|:------------|:----------|:--------| | Stock options to purchase common stock | 821,464 | 608,547 | 468,122 | | Unvested restricted stock units | 36,981 | 29,698 | 10,888 | | Common stock warrants | 2,435,808 | 296,296 | — | | **Total** | **3,294,253** | **934,541** | **479,010** | - There is no difference between basic and diluted net loss per share because the effects of potentially dilutive securities are antidilutive due to the net loss position[480](index=480&type=chunk) [(13) Income Taxes](index=82&type=section&id=(13)%20Income%20Taxes) BioCardia reported no income tax provision, utilizing significant federal and state net operating loss carryforwards offset by a full valuation allowance - BioCardia's provision for income taxes was **$0** for the years ended December 31, 2019, 2018, and 2017[534](index=534&type=chunk) Reconciliation of Income Tax Provision (in thousands) | Metric | 2019 | 2018 | 2017 | |:----------------------------------------|:---------|:---------|:---------| | Tax at federal statutory rate | ($3,089) | ($2,937) | ($4,185) | | State, net of federal benefit | ($414) | ($455) | ($1,238) | | Research and development credit | ($225) | ($236) | ($135) | | Stock-based compensation | $446 | $440 | $344 | | Change in Federal Tax Rate | — | — | $8,172 | | Other | $5 | $22 | $7 | | Change in valuation allowance | $3,277 | $3,166 | ($2,965) | | **Total provision for income taxes** | **$—** | **$—** | **$—** | - The company has approximately **$80.5 million in federal** and **$58.6 million in state net operating loss carryforwards** as of December 31, 2019, with federal NOLs generated after 2017 having no expiration date[537](index=537&type=chunk) - A full valuation allowance offsets net deferred tax assets, as their realizability is not considered more likely than not[540](index=540&type=chunk) [(14) Contingencies and Uncertainties](index=83&type=section&id=(14)%20Contingencies%20and%20Uncertainties) BioCardia faces no material legal proceedings but acknowledges the highly uncertain and potentially adverse impact of the COVID-19 pandemic - BioCardia is not aware of any current legal or administrative proceedings likely to have an adverse effect on its business, financial position, results of operations, or cash flows[543](index=543&type=chunk) - The COVID-19 pandemic, declared in March 2020, is causing major disruptions globally and may affect BioCardia's operations, supply chain, preclinical and clinical studies, employee resources, and ability to access capital[545](index=545&type=chunk)[546](index=546&type=chunk) - The ultimate impact of COVID-19 is highly uncertain and could have a material adverse effect on the company's liquidity, capital resources, operations, and business[546](index=546&type=chunk) [(15) Grant Funding](index=84&type=section&id=(15)%20Grant%20Funding) BioCardia received a $750,000 grant from TEDCO for its Heart Failure Trial, with a portion recorded as a refundable liability - In June 2016, BioCardia entered a grant agreement with Maryland Technology Development Corporation (TEDCO) for up to **$750,000** to finance the 'Heart Failure Trial' research project, extended to June 2020[547](index=547&type=chunk) - As of December 31, 2019, **$750,000 has been received**, with **$120,000** in qualifying costs incurred and the remaining **$630,000** recorded as a refundable grant liability[548](index=548&type=chunk) [(16) Related Party Transactions](index=84&type=section&id=(16)%20Related%20Party%20Transactions) BioCardia engages in related party transactions, including securities sales and convertible notes with officers, directors, and principal stockholders, governed by audit committee policy - BioCardia previously had a consulting agreement with OPKO Health, Inc., whose chairman and CEO is a principal stockholder[549](index=549&type=chunk) - The agreement was terminated in August 2019, but OPKO's stock option grant was amended to continue vesting[550](index=550&type=chunk)[551](index=551&type=chunk) - In July 2019, BioCardia issued **$625,000** in convertible promissory notes to accredited investors, including certain officers, directors, and a principal stockholder, which converted into units of common stock and warrants upon a public offering[552](index=552&type=chunk) - In December 2018, the company sold **592,592 shares of common stock** and warrants to purchase **296,296 shares** to entities affiliated with existing investors, including Chairman Dr. Simon H. Stertzer and Frost Gamma Investments Trust, for **$3.8 million** net proceeds[553](index=553&type=chunk) [(17) Employee Benefit Plans](index=85&type=section&id=(17)%20Employee%20Benefit%20Plans) BioCardia offers a 401(k) retirement plan to U.S. employees, with the company making matching contributions - BioCardia's U.S. employees are eligible for a 401(k) retirement and savings plan, allowing contributions up to **75% of pretax salary**[554](index=554&type=chunk) - The company made matching contributions of **$25,000** in 2019 and **$26,000** in 2018 to the 401(k) plan[554](index=554&type=chunk) [(18) Subsequent Events](index=85&type=section&id=(18)%20Subsequent%20Events) Subsequent events include the repricing of stock options in January 2020 and the ongoing, uncertain impact of the COVID-19 pandemic - In January 2020, certain outstanding stock options were repriced to **$5.32 per share** following stockholder approval in November 2019, which is expected to result in immaterial incremental compensation cost[556](index=556&type=chunk) - The COVID-19 pandemic, declared in March 2020, is causing global disruptions, and its full financial and operational impact on BioCardia's business, clinical programs, and financing ability is uncertain but could be material and adverse[557](index=557&type=chunk) [ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=85&type=section&id=ITEM%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) BioCardia, Inc. reported no changes in or disagreements with accountants on accounting and financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure[558](index=558&type=chunk) [ITEM 9A. Controls and Procedures](index=85&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) BioCardia's disclosure controls were ineffective due to a material weakness in technical accounting resources, though financial statements are deemed fairly presented - As of December 31, 2019, BioCardia's disclosure controls and procedures were deemed not effective due to a material weakness in internal control over financial reporting[560](index=560&type=chunk)[564](index=564&type=chunk) - The material weakness relates to a lack of sufficient technical resources for effective and timely review of complex non-routine transactions and new accounting standards[566](index=566&type=chunk) - Despite the material weakness, management concluded that the consolidated financial statements in the Form 10-K fairly present the company's financial position, results of operations, and cash flows[560](index=560&type=chunk) - Remediation measures include enhancing control processes for identifying and reviewing non-routine transactions and engaging external technical accounting consultants[567](index=567&type=chunk) [ITEM 9B. Other Information](index=86&type=section&id=ITEM%209B.%20Other%20Information) BioCardia, Inc. reported no other information required by this item - There is no other information to report[569](index=569&type=chunk) [PART III](index=86&type=section&id=PART%20III) [ITEM 10. Directors, Executive Officers and Corporate Governance](index=86&type=section&id=ITEM%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) BioCardia's board, with independent directors and separated CEO/Chairman roles, oversees governance through audit, compensation, and nominating committees - BioCardia's board of directors has **eight members**, with all directors except Dr. Peter Altman (President, CEO) qualifying as independent under NASDAQ listing standards[570](index=570&type=chunk)[572](index=572&type=chunk)[591](index=591&type=chunk) - The board maintains a separated CEO and Chairman structure, with Dr. Altman as CEO and Dr. Simon H. Stertzer as Chairman[593](index=593&type=chunk) - The board has established an Audit Committee (chaired by Jay Moyes), a Compensation Committee (chaired by Richard Pfenniger), and a Nominating and Corporate Governance Committee (chaired by Simon Stertzer), all composed of independent directors[594](index=594&type=chunk)[597](index=597&type=chunk)[599](index=599&type=chunk)[601](index=601&type=chunk) - Non-employee directors receive annual cash retainers and equity grants, with cash payments deferred until sufficient financing is raised[603](index=603&type=chunk)[605](index=605&type=chunk) - Key executive officers include Peter Altman (President, CEO), Henricus Duckers (Chief Medical Officer), David McClung (Chief Financial Officer), and Phil Pesta (Vice President of Operations)[614](index=614&type=chunk)[615](index=615&type=chunk)[616](index=616&type=chunk)[617](index=617&type=chunk) - Several executive officers and directors had delinquent Section 16(a) reports for transactions in 2018 and 2019[619](index=619&type=chunk) - The company has adopted a Code of Business Conduct and Ethics applicable to all officers, employees, agents, and representatives[613](index=613&type=chunk) [ITEM 11. Executive Compensation](index=94&type=section&id=ITEM%2011.%20Executive%20Compensation) This section details the compensation for BioCardia's named executive officers (NEOs) for fiscal years 2018 and 2019, including salary, stock awards, and option awards. All NEOs are employed on an at-will basis and are eligible for annual bonuses and equity compensation. The company has change of control and severance agreements in place, providing lump sum payments, health insurance continuation, and accelerated equity vesting under specific termination or change of control scenarios. As of December 31, 2019, NEOs held various outstanding equity awards, with some options repriced in January 2020. The company also maintains a 401(k) savings plan for eligible employees Fiscal 2019 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards ($) (1) | Option Awards ($) (1) | Total ($) | |:--------------------------------------|:-----|:-------------|:----------|:---------------------|:----------------------|:-------------| | Peter Altman, Ph.D. | 2019 | 362,700.00 | — | 57,600.00 (2) | 257,200.98 (4) | 677,500.98 | | President, Chief Executive Officer, and Director | 2018 | 360,000.00 | — | — | 742,000.00 (3) | 1,102,000.00 | | David McClung | 2019 | 302,250.00 | — | 30,000.00 (2) | 102,244.76 (4) | 434,494.76 | | Chief Financial Officer | 2018 | 300,000.00 | — | — | 294,982.10 (3) | 594,982.10 | | Henricus Duckers | 2019 | 350,000.00 | — | 14,000.00 (2) | 107,945.94 (4) | 471,945.94 | | Chief Medical Officer | 2018 | 350,000.00 | — | — | 311,417.40 (3) | 661,417.40 | -

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) ...

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 ...

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. ...

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 ...