Core Insights - BioCardia, Inc. has been granted Japanese Patent No. 7641330 for its "Radial and Transendocardial Delivery Catheter," which will expire on or after September 30, 2034, enhancing its patent position in minimally invasive catheter-based delivery systems for cell and gene therapies [1][2] Company Overview - BioCardia is a global leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [4] - The company has developed two main biotherapeutic platforms: CardiAMP (autologous) and CardiALLO (allogeneic) cell therapies, with three clinical stage product candidates currently in development [4] Patent and Technology - The newly issued patent describes minimally invasive interventional biotherapeutic delivery catheters designed to deliver biologic therapies directly to the heart, minimizing off-target toxicities and avoiding surgical access [2][3] - BioCardia's Helix System is noted as the only catheter-based intramyocardial delivery system currently in active clinical use, supported by data indicating it is the safest and most efficient method for biotherapeutic delivery to the heart [2][3] Market Position - Japan is identified as a crucial initial market for BioCardia's therapies due to its commitment to supporting novel and cost-effective cell therapy solutions for its aging population, alongside the development of the Japanese stem cell industry [2]

Core Insights - BioCardia, Inc. has completed source data verification and frozen primary outcomes data for the Phase 3 CardiAMP HF study, focusing on autologous cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - The study represents the largest cohort of ischemic HFrEF patients in a randomized trial of autologous cell therapy and employs a precision medicine approach to identify likely responders [2] - Results from the study are expected to be presented at the American College of Cardiology (ACC) 2025 Scientific Sessions on March 30, 2025 [1] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [5] - The CardiAMP Cell Therapy has received FDA Breakthrough designation and aims to stimulate natural healing responses in patients through a minimally invasive procedure [3][5] - The clinical development of CardiAMP is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) [4]

Core Insights - BioCardia, Inc. has completed enrollment and dosing in the low dose cohort of its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial aimed at treating patients with ischemic heart failure of reduced ejection fraction (HFrEF) [1][2] - The trial is notable for being the world's first prospective study of allogeneic mesenchymal stem cells (MSC) for HFrEF patients with elevated markers of heart stress and systemic inflammation [1][3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with a focus on developing therapies like CardiAMP™ and CardiALLO for heart disease [5][6] - The company is headquartered in Sunnyvale, California, and is also involved in biotherapeutic delivery partnerships for various heart-related conditions [6] Clinical Trial Details - The CardiALLO Heart Failure Trial consists of a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo-controlled cohort [2][3] - The Phase I trial involves treating three patients at escalating doses of 20 million, 100 million, and 200 million cells, utilizing a minimally invasive delivery system [2][3] - A Data Safety Monitoring Board (DSMB) will review safety data after each dose cohort, with the first review expected in March 2025 [2][3] Treatment Mechanism - The "off the shelf" MSCs used in the study are believed to provide immunomodulatory benefits and promote microvascular repair, enhancing capillary density and reducing fibrosis in patients with inflammatory disease-mediated heart failure [3][4] - Previous clinical trials have shown safety and trends of efficacy for these allogeneic cells without the need for immunosuppression or causing arrhythmias [3] Future Prospects - The current study aims to position the CardiALLO MSC therapy for pivotal clinical studies in the U.S. and conditional approval in Japan [4] - Enhanced manufacturing capabilities for MSCs are expected to be commercially scalable, supporting potential partnerships for other indications [4]

Core Insights - BioCardia, Inc. announced that the results of its CardiAMP HF Phase 3 study will be presented at the American College of Cardiology 2025 Scientific Sessions [1] - The CardiAMP autologous cell therapy has received FDA Breakthrough designation and aims to treat microvascular dysfunction through a minimally invasive procedure [3] Group 1: Study Presentation - The CardiAMP HF Phase 3 study results will be presented by Dr. Amish N. Raval on March 30, 2025, during a late-breaking clinical trials session [2] - The American College of Cardiology Scientific Sessions is a prominent forum for cardiovascular clinical trials, attracting experts from various related fields [2] Group 2: CardiAMP Cell Therapy - CardiAMP Cell Therapy utilizes a patient's own marrow cells to potentially enhance the body's natural healing response, targeting mechanisms of microvascular dysfunction [3] - The therapy aims to increase capillary density, reduce tissue fibrosis, and counteract fibrotic, inflammatory, apoptotic, and endothelial dysfunction through the production of growth factors and cytokines [3] Group 3: Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with multiple clinical stage product candidates [5] - The company’s therapies are supported by the Maryland Stem Cell Research Fund and are reimbursed by the Centers for Medicare and Medicaid Services [4]

Core Insights - BioCardia, Inc. has announced the commercial availability of its Morph DNA steerable introducer product family, which is currently being utilized in ongoing cell-therapy clinical trials [1][2] - The company is focusing on organic sales pipeline development without incurring costs associated with a direct sales force or third-party partners [2] - BioCardia is concentrating on its CardiAMP Heart Failure I and II clinical trials, with final results expected by the end of Q1 2025 [2] Product Details - The Morph DNA steerable introducer family is designed for enhanced control in biotherapeutic delivery procedures within the heart, featuring bidirectional steering and ergonomic actuation [3] - The design includes tensioning elements that allow consistent catheter performance in any direction, resembling a double helix structure [4] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [6]

Core Insights - BioCardia, Inc. has successfully completed a consultation with Japan's PMDA regarding the registration submission for its lead therapeutic asset, BCDA-01, aimed at treating ischemic heart failure of reduced ejection fraction (HFrEF) [1][2] Group 1: Consultation Outcomes - The PMDA has invited BioCardia for a subsequent consultation after the submission of final clinical data with a two-year follow-up to assess the evidence supporting safety and efficacy claims for the BCDA-01 program [2] - PMDA is open to considering results from the CardiAMP Heart Failure Trial and previous trials as sufficient evidence for registering the CardiAMP Cell Therapy System for heart failure patients in Japan [2] Group 2: Clinical Trials and Data - BioCardia is currently working on data lock from the fully enrolled 125 patient CardiAMP Heart Failure Trial, with final data expected to be available in the first quarter of 2025 [2] - The CardiAMP Cell Therapy for HFrEF (BCDA-01) has received Breakthrough Designation from the FDA CBER, with development supported by the Maryland Stem Cell Research Fund [2] Group 3: Company Overview - BioCardia, Inc. is headquartered in Sunnyvale, California, and is recognized as a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [3] - The company has two biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates in development [3]

Financial Performance - The net loss for Q3 2024 was approximately $1.7 million, compared to approximately $2.6 million in Q3 2023, indicating a reduction in losses[10]. - Selling, general and administrative expenses decreased to approximately $825,000 in Q3 2024 from approximately $1.1 million in Q3 2023[10]. - Research and development expenses for Q3 2024 were approximately $931,000, down from approximately $1.9 million in Q3 2023, reflecting the completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial[9]. Funding and Assets - The company closed a $7.2 million upsized public offering in September 2024[7]. - Total assets increased to $6.267 million as of September 30, 2024, compared to $2.987 million as of December 31, 2023[19]. Clinical Trials and Regulatory Updates - The FDA accepted plans for completing patient follow-up in the CardiAMP Heart Failure Trial, with final data transfer expected in Q1 2025[2]. - A submission to Japan's PMDA has been completed, with a consultation scheduled for late November 2024[3]. - The FDA approved a protocol amendment for the CardiAMP Heart Failure II Trial, increasing patient eligibility[4]. - The last patient in the low-dose cohort of the CardiALLO Cell Therapy is expected to be enrolled in Q4 2024[5]. - The company anticipates top line data release for the CardiAMP Heart Failure Trial in Q1 2025[11].

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].