Financial Performance - Net loss for the three months ended September 30, 2024, was $1,737,000, a decrease from a net loss of $2,574,000 for the same period in 2023, reflecting a 32.6% improvement[12] - Net loss per share improved to $(0.61) for the three months ended September 30, 2024, compared to $(1.79) for the same period in 2023, a 66.1% enhancement[12] - As of September 30, 2024, BioCardia, Inc. reported a net loss of $5.65 million, a decrease from a net loss of $9.5 million for the same period in 2023, representing a 40% improvement[16] - The company has incurred net losses and negative cash flows from operations since inception, with expectations of continued losses as clinical trials advance[24] - As of September 30, 2024, the company had an accumulated deficit of approximately $157.8 million and anticipates continuing to incur net losses for the next several years[89] Assets and Liabilities - Total current assets increased to $5,056,000 as of September 30, 2024, compared to $1,461,000 as of December 31, 2023, representing a growth of 246%[10] - Cash and cash equivalents increased significantly to $4,930,000 as of September 30, 2024, compared to $1,103,000 as of December 31, 2023, marking a rise of 346%[10] - Total liabilities decreased to $3,514,000 as of September 30, 2024, from $4,590,000 as of December 31, 2023, showing a reduction of 23.4%[10] - Total stockholders' equity improved to $2,753,000 as of September 30, 2024, from a deficit of $(1,603,000) as of December 31, 2023, indicating a positive shift in equity[10] - Cash and cash equivalents as of September 30, 2024 were approximately $4.9 million[89] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $2,972,000, down from $6,570,000 for the same period in 2023, indicating a reduction of 54.7%[12] - BioCardia's CardiAMP® therapy platform is in pivotal trials for ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina, targeting significant unmet medical needs[18] - The company has been focusing on research and development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases[18] - The company plans to increase research and development expenses to continue pivotal trials for CardiAMP and CardiALLO cell therapies[80] Financing Activities - BioCardia's financing activities generated $9.29 million in net cash for the nine months ended September 30, 2024, compared to $2.61 million in the prior year[16] - The company raised gross proceeds of $7.2 million from a public offering on September 3, 2024, with associated issuance costs of $926,000[42] - The company sold 412,239 shares under ATM offerings during the nine months ended September 30, 2024, generating approximately $2.4 million in gross proceeds[46] - Net cash provided by financing activities was approximately $9.3 million for the nine months ended September 30, 2024, compared to approximately $2.6 million for the same period in 2023[91] Operational Challenges - BioCardia, Inc. plans to raise additional capital to fund operations beyond the second quarter of 2025, as current cash reserves are insufficient[25] - The company anticipates needing additional funding to continue the development of its therapeutic candidates, potentially through non-dilutive collaboration, licensing arrangements, or debt/equity financing[98] - There is substantial doubt about the company's ability to continue as a going concern within one year, heavily reliant on its ability to raise additional capital[102] - If the company cannot secure adequate funds, it may need to reduce operating expenses or cease operations[102] Share-Based Compensation - The company reported share-based compensation expenses of $565,000 for the nine months ended September 30, 2024, down from $846,000 in the same period of 2023[16] - Share-based compensation expense for Q3 2024 was $177,000, a decrease of 29.4% from $251,000 in Q3 2023[8] - Total share-based compensation for the nine months ended September 30, 2024, was $565,000, down 33.2% from $846,000 in the same period of 2023[8] - Unrecognized share-based compensation for options granted through September 30, 2024, is $837,000, to be recognized over 1.8 years[49] Clinical Trials and Product Development - The CardiAMP Heart Failure Trial enrolled 115 patients, with final data transfer expected in Q1 2025[61] - Interim results of the CardiAMP Heart Failure II Trial showed an 86% relative risk reduction in mortality[63] - The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is designed to enroll up to 343 patients, focusing on refractory angina[68] - The open-label roll-in cohort for chronic myocardial ischemia showed an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes[69] - The FDA approved a protocol amendment for the CardiAMP Heart Failure II Trial, allowing more patients to receive treatment[65] - The FDA approved the Morph-DNA product family for market release in August 2024, with first commercial devices expected in November 2024[75] - The company has entered into biotherapeutic delivery partnerships, including a Phase I/II Clinical Study with StemCardia, expected to enhance future treatment options for heart disease[73] Lease and Operating Expenses - The operating lease expense was $121,000 for both the three months ended September 30, 2024, and 2023, and $362,000 for both the nine months ended September 30, 2024, and 2023[37] - Future minimum lease payments under the operating lease total $1.18 million as of September 30, 2024, with total operating lease liabilities at $1.05 million[38] - The company’s weighted average remaining lease term was 2.34 years, with a weighted average discount rate of 10.74% as of September 30, 2024[37] Revenue - Revenue for the three months ended September 30, 2024 was $0, compared to $357,000 for the same period in 2023, and for the nine months ended September 30, 2024, revenue decreased to $58,000 from $464,000 in 2023[86]

Group 1 - BioCardia, Inc. has regained full compliance with Nasdaq Capital Market's Listing Requirements as of September 17, 2024, following a decision by the Hearing Panel on May 13, 2024 [1] - The company demonstrated compliance with Listing Rule 5550(b)(1), allowing it to continue listing its securities on the Nasdaq Stock Market [1] - This compliance follows the company's successful efforts to improve its balance sheet, including raising new capital for the development of therapeutic candidates and advancing approved products [1] Group 2 - Recent developments include FDA approval for the CardiAMP® Cell Therapy Heart Failure II protocol amendment, allowing for a more tailored treatment plan for patients [2] - The University of Wisconsin has treated the last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial, indicating progress in clinical trials [2] - BioCardia secured FDA market clearance for its Morph® DNA™ product family and closed a $7.2 million financing to support ongoing efforts [2] Group 3 - BioCardia is a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its main product platforms being CardiAMP® and CardiALLO™ cell therapies [3] - The company has three clinical stage product candidates in development, supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms [3]

Core Viewpoint - BioCardia, Inc. has successfully closed an upsized public offering, raising $7.2 million to support its biotherapeutic development and corporate purposes [1][2]. Group 1: Offering Details - The public offering included the sale of 2,400,000 shares of common stock and warrants to purchase an additional 2,400,000 shares at a combined price of $3.00 per share [1]. - The offering was conducted under Nasdaq rules and was priced at the market [1]. - The warrants have an exercise price of $3.00 per share, are immediately exercisable, and will expire five years from the issuance date [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including advancing investigational biotherapeutic candidates and the biotherapeutic delivery partnering business [2]. Group 3: Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [4]. - The company has two main biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [4].

Core Insights - BioCardia, Inc. has received FDA clearance to market the Morph DNA Steerable Introducer product family, which is designed for use in cardiovascular and pulmonary disease treatments [1][2] - The Morph DNA product family includes sixteen products with various lengths and diameters, aimed at enhancing interventional cardiology and related procedures [1][2] Product Overview - The Morph DNA Steerable Introducer allows for the introduction of medical instruments into the peripheral and coronary vasculature, covering a range of clinical applications [1][2] - The product family is expected to improve procedures such as renal denervation, endovascular aortic repair, and atrial fibrillation mapping and ablation, potentially benefiting over a million procedures annually in the U.S. [2][3] Design Features - The Morph DNA design includes bidirectional steering, ergonomic actuation, and a proprietary layup for torque response, aimed at enhancing control and navigation during procedures [4] - The design incorporates tensioning elements that allow for consistent catheter performance and smooth navigation, reducing the risk of sudden movements during use [4] Company Background - BioCardia is a leader in cellular and cell-derived therapeutics, with a focus on cardiovascular and pulmonary diseases, and has three clinical stage product candidates in development [5]

Patented personalized medicine approach for patient dosing for autologous cell therapyExpected to meaningfully enhance clinical experience and market opportunity SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia’s confirmatory Phase 3 trial of i ...

BioCardia, Inc. (NASDAQ:BCDA) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and CEO David McClung - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Laura Suriel - Alliance Global Partners Kevin Marshall - Innovative Financial Group Operator Ladies and gentlemen, thank you for standing by. Good afternoon. And welcome to the BioCardia Second Quarter 2024 Financial Results and Busi ...

SUNNYVALE, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. ...

Exhibit 99.1 BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results Sunnyvale, Calif. – August 13, 2024 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conf ...

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, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of incorporation or organization) ...

SUNNYVALE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has submitted a 510(k) for approval of its patented Morph® DNA™ Steerable Introducer Sheath. This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripher ...