Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States. SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the study's in ...

CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif., April 11, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global ...

BioCardia (BCDA) Q4 2024 Earnings Call April 01, 2025 02:50 AM ET Company Participants Miranda Fido - Investor RelationPeter Altman - President & Chief Executive OfficerDavid McClung - Chief Financial OfficerJoe Pantginis - Managing Director Conference Call Participants Kumaraguru Raja - Senior Biotechnology AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioC ...

A webcast replay of the call will be available approximately one hour after the end of the call at the above links. To access the replay internationally, please use the link https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-877-344-7529 (domestic), 1- 412-317-0088 (international) or 855-669-9658 (Canada) by using access code 6220156. Media Contact: Miranda Peto, Marketing / Investor Relations Email: mpeto@BioCardia.com Pho ...

SUNNYVALE, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today clarifies that two-year CardiAMP-HF results will be addressed in a conference call scheduled for today, Monday, March 31, 2025 at 4:30pm EDT. The press release earlier this morning incorrectly noted the call would be held at 4:30pm PDT. Participants can register for the conference by navigating to htt ...

Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy Patient improvements through two years suggest single dose of Cardi ...

Financial Performance - Net cash used in operations was approximately $8.0 million in 2024, a decrease from approximately $10.0 million in 2023[9] - Revenues for 2024 were approximately $58,000, down from approximately $477,000 in 2023, primarily due to the fulfillment of performance obligations[9] - Research and development expenses decreased to approximately $4.4 million in 2024 from approximately $7.7 million in 2023, reflecting reduced clinical expenses[9] - Selling, general and administrative expenses decreased to approximately $3.7 million in 2024 from approximately $4.4 million in 2023, due to personnel realignment and cost reductions[9] - The net loss for 2024 was approximately $7.9 million, compared to approximately $11.6 million in 2023[9] - Cash and cash equivalents at the end of 2024 totaled $2.4 million, an increase from $1.1 million at the end of 2023[17] Clinical Trials and Developments - The CardiAMP HF Trial's last protocol-specified follow-up visit has been completed, with data analysis nearing completion for presentation at the American College of Cardiology Scientific Sessions[5] - The first commercial Morph DNA steerable introducer devices have been manufactured and are now available for use in clinical trials and procedures[6] - The company anticipates finalizing the initial trial manuscript for publication and accelerating enrollment activities in the CardiAMP HF II Trial in the coming weeks[5] - The company is preparing for a consultation with Japan's PMDA regarding the registration of the CardiAMP Cell Therapy System for heart failure treatment[5]

Financial Performance - The company reported a net loss of $7.9 million for the year ended December 31, 2024, with an accumulated deficit of $160.1 million[157]. - Cash and cash equivalents were approximately $2.4 million as of December 31, 2024, which may not be sufficient to fund operations beyond May 2025[161]. - The company has limited commercialization experience, making it difficult to predict future financial performance[158]. - The acceptance of products is critical for generating significant revenue, and any lack of market acceptance could adversely affect financial performance[198]. - The company may need to seek additional financing, which could be dilutive to existing shareholders[161]. - The company does not intend to pay dividends on its common stock, and any returns will be limited to stock appreciation[308]. Revenue Generation - The company has not generated any revenue from its cell therapy systems and does not anticipate doing so in the next few years[159]. - Regulatory approvals and market acceptance are essential for the company's future revenue generation[160]. - Future commercial success depends on achieving market acceptance of therapeutic candidates among physicians, patients, and payors[197]. Research and Development - The company expects to incur significant research and development expenses as it continues to advance its therapeutic candidates[160]. - The ongoing Phase III pivotal trial for the CardiAMP Cell Therapy System is critical for regulatory approval, but there are no guarantees of success[170]. - The company may face challenges in obtaining regulatory approval for its therapeutic candidates due to various factors, including the inability to successfully complete clinical trials or demonstrate safety and efficacy[239]. Regulatory Environment - The CardiAMP Cell Therapy System is the first cardiac cell-based therapy with an accepted pivotal trial regulated by the FDA via the premarket approval pathway, but the approval process remains uncertain[172]. - No cell-based therapies have been approved in the United States for cardiac indications, making it difficult to predict the time and cost for obtaining regulatory approvals[174]. - The regulatory approval process for novel product candidates like the CardiAMP Cell Therapy System may be more expensive and take longer than for better-known pharmaceutical products[175]. - Regulatory requirements for cell-based therapy products have changed frequently, which may lengthen the review process and increase development costs[176]. - The company must report any serious adverse events to regulatory authorities, which could result in sanctions if not done timely[225]. - Regulatory approval may be limited to certain territories and indications, impacting the commercial potential of therapeutic candidates[240]. Clinical Trials - The company has encountered substantial delays in clinical studies, which could negatively affect the ability to complete trials and obtain regulatory approval[177]. - Patient enrollment in clinical trials is critical, and negative publicity or competition may delay recruitment and testing timelines[179]. - The company relies on third-party manufacturers and CROs for clinical trials, which may lead to delays if these parties do not meet their contractual obligations[189]. Competition and Market Dynamics - The company faces substantial competition from larger firms with more resources, which may hinder its ability to compete effectively[201]. - Establishing sales and marketing capabilities is essential for generating revenues, and failure to do so could impact commercialization efforts[202]. - Competition from biosimilars may increase due to changes in the regulatory environment, potentially affecting the market for allogeneic therapies[243]. Manufacturing and Supply Chain - The company relies on third-party vendors for manufacturing components, which exposes it to risks such as supply shortages and price fluctuations[195]. - Significant delays or interruptions in the supply of components could impair the company's ability to meet customer demand[196]. - The company intends to expand manufacturing capacity, but this may require changes in production processes and could lead to delays[210]. Legal and Compliance Risks - The company is subject to extensive healthcare regulations, and non-compliance could adversely affect its operations and financial condition[244]. - Violations of healthcare laws could result in severe penalties, including exclusion from federal healthcare programs and reputational harm[248]. - The company faces risks from product liability lawsuits, which could result in substantial liabilities and limit the commercialization of its therapeutic candidates[260]. Intellectual Property - The complexity of patent protection for biotherapeutics creates uncertainties that could adversely impact the company's competitive position and financial performance[279]. - The company has not conducted a freedom-to-operate search for its therapeutic candidates, raising concerns about potential patent infringement claims from third parties[288]. - Recent patent reform legislation could increase uncertainties and costs surrounding the prosecution and enforcement of the company's patents, potentially impacting its business[285]. Management and Operational Risks - Attracting and retaining senior management and key scientific personnel is critical for the successful development and commercialization of therapeutic candidates[263]. - The company plans to commercialize the CardiAMP Cell Therapy System using an internal sales force, which may require significant management attention and resources[266]. - The company's disaster recovery and business continuity plans are currently limited, which could lead to substantial expenses and operational disruptions in the event of a natural disaster[273]. Financial Market Risks - The company has regained compliance with the Nasdaq's Minimum Bid Price Requirement and the Market Value of Listed Securities Requirement, but is not currently compliant with the minimum stockholders' equity requirement of $2.5 million, risking potential delisting[294]. - The market price of the company's securities may be volatile, influenced by various factors including clinical trial results and regulatory actions[295]. - The company is classified as a "smaller reporting company," which may make it more challenging for investors to analyze its financial results and prospects[298].

Core Insights - BioCardia, Inc. reported its financial results for the year ended December 31, 2024, highlighting a decrease in net loss and operational cash usage compared to 2023 [4][11][15]. Financial Performance - Net cash used in operations was approximately $8.0 million in 2024, down from $10.0 million in 2023, primarily due to reduced research and development expenses [4]. - Revenues for 2024 were approximately $58,000, a significant decrease from approximately $477,000 in 2023, attributed to the fulfillment of performance obligations for business partners [11]. - Research and development expenses decreased to approximately $4.4 million in 2024 from approximately $7.7 million in 2023, reflecting reduced clinical expenses following the completion of the CardiAMP HF Trial [11]. - Selling, general, and administrative expenses also decreased to approximately $3.7 million in 2024 from approximately $4.4 million in 2023 due to personnel realignment and cost reductions [11]. - The net loss for 2024 was approximately $7.9 million, down from approximately $11.6 million in 2023, with a net loss per share of $2.90 compared to $8.19 in the previous year [11][15]. Clinical Developments - The CardiAMP autologous cell therapy for ischemic heart failure has completed its last patient enrollment in the open-label roll-in cohort, with results expected for publication and presentation [3]. - The treatment of the low dose cohort for the CardiALLO cell therapy has been completed without any treatment-emergent adverse events, with a formal Data Safety Monitoring Board review scheduled for the second quarter of 2025 [3]. - A consultation with Japan's PMDA regarding the registration of the CardiAMP Cell Therapy System for heart failure has taken place, with indications that previous trial results may suffice for registration [5]. Upcoming Events - The company will host a corporate update conference call on March 31, 2025, to discuss results from the CardiAMP HF Trial at the American College of Cardiology 2025 Scientific Sessions [2][8].

Company Overview - BioCardia, Inc. is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases [2] - The company is headquartered in Sunnyvale, California and focuses on developing biotherapeutic platforms, including CardiAMP autologous and CardiALLO™ allogeneic cell therapies [2] Financial Reporting - BioCardia will report its financial results for the year ended December 31, 2024 on March 26, 2025 [1] - A corporate update conference call is scheduled for March 31, 2025, following a presentation at the American College of Cardiology 2025 Scientific Sessions [1] Clinical Development - BioCardia has three cardiac clinical stage product candidates in development, enabled by its Helix™ biotherapeutic delivery and Morph vascular navigation product platforms [2] - The company will present results from the CardiAMP-HF Trial, a double-blind, randomized controlled trial of an autologous cell therapy in patients with heart failure with reduced ejection fraction (HFrEF), on March 30, 2025 [1]