BioCardia(BCDA)

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BioCardia(BCDA) - 2024 Q4 - Earnings Call Transcript
2025-03-31 20:30
Financial Data and Key Metrics Changes - Total expenses decreased by 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023, primarily driven by a 43% reduction in research and development expenses to $4.4 million from $7.7 million [35][36] - Net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023, and net cash used in operations was approximately $8 million, a 20% decrease from approximately $10 million in 2023 [37][38] - The company ended the year with cash and cash equivalents totaling $2.4 million, with expectations of a moderate increase in cash burn in 2025 [38] Business Line Data and Key Metrics Changes - The CARDI-AMP Heart Failure Trial data showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events [14][19] - Quality of life improvements were noted with a 10.5% point increase in quality of life scores and a 13.9-meter improvement in the six-minute walk distance test [14][15] Market Data and Key Metrics Changes - The market reaction to the trial results was unexpected, as the data was aligned with previous expectations despite not meeting the primary endpoint [18][19] - The company anticipates that the compelling data will enhance interest from distribution partners and strategics, particularly in the context of increasing attention on interventional therapies for heart failure [29] Company Strategy and Development Direction - The company is focused on advancing its lead therapeutic candidate, autologous cardiac cell therapy, and plans to share two-year data with regulatory authorities to align on pathways for making the therapy available [21][24] - Ongoing discussions with regulatory agencies aim to highlight the safety and efficacy of cardiac cell therapy, emphasizing the lack of long-term safety issues compared to traditional therapies [23][24] - The company is also progressing in other therapeutic programs, including the Cardi-AMP Cell Therapy and Chronic Myocardial Ischemia Trial [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strength of the two-year data and its potential impact on future trials and regulatory discussions [43][70] - The company is preparing a submission package for the PMDA in Japan, with expectations for a consultation meeting soon [78][82] - Management acknowledged the need for continued engagement with regulatory authorities to ensure a smooth approval process [81] Other Important Information - The company has completed enrollment in the low-dose cohort of its cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure [26] - The Helix biotherapeutic delivery platform is expected to enhance future commercialization and clinical development efficiency [31][32] Q&A Session Summary Question: Can you provide more details on PMDA discussions in Japan? - Management met with PMDA in November and is preparing to share two-year data, which looks promising for potential conditional approval in Japan [42][43] Question: Were there any subsequent therapies that could have impacted the data read? - All patients were on guideline-directed medical therapy, and no other medications were introduced during the trial [47][50] Question: What is the expected timeline for sharing two-year data with the FDA? - The company is compiling the data for submission and expects to have a meeting with the FDA soon, with a timeline potentially as short as three weeks [70][82] Question: How does the data from Heart Failure 1 inform Heart Failure 2 trials? - The primary endpoint structure remains the same, and the company aims to replicate the positive outcomes observed in the first trial [88] Question: What are the next steps regarding interactions with the PMDA? - The company is preparing a submission package and scheduling a consultation meeting with the PMDA, with expectations for a timeline of three to eight weeks [78][82]
BioCardia's Conference Call Today, Monday, March 31, 2025 to be Held at 4:30PM EDT Time Today
Newsfilter· 2025-03-31 17:39
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 ...
BioCardia’s Conference Call Today, Monday, March 31, 2025 to be Held at 4:30PM EDT Time Today
Globenewswire· 2025-03-31 17:39
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 ...
Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years
Newsfilter· 2025-03-31 12:00
Core Insights - BioCardia, Inc. announced two-year outcomes from the Phase 3 CardiAMP-HF study, demonstrating the efficacy of CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction [1][2][3] Group 1: Clinical Trial Results - The CardiAMP-HF Trial involved 115 ischemic heart failure patients across 18 centers in the U.S. and Canada, showing that patients receiving CardiAMP therapy alongside medication experienced decreased mortality and major adverse cardiac and cerebrovascular events (MACCE) [2][4] - Statistically significant improvements were observed in patients with elevated NTproBNP, indicating greater benefits for those under active heart stress [4][5] - Treated patients exhibited a 13% reduction in heart death equivalents and a 47% relative risk reduction in heart death equivalents compared to those on medication alone [5] Group 2: Quality of Life Improvements - Patients receiving CardiAMP therapy reported a clinically meaningful 10.5-point improvement in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [5] - Improvements in physical capacity were noted, with a 13.9-meter increase in Six Minute Walk Distance for treated patients [5] Group 3: Mechanism and Market Potential - CardiAMP Cell Therapy is designated as a Breakthrough Therapy by the FDA, utilizing a pre-procedural cell analysis, a high target dosage of cells, and a minimally invasive delivery system [3][6] - The therapy targets mechanisms leading to microvascular dysfunction, potentially benefiting around one million patients in the U.S. who currently incur $30 billion annually in healthcare costs [7][8] Group 4: Future Directions - BioCardia plans to share the two-year data with the U.S. FDA and Japan PMDA to expedite the therapy's availability for patients [7] - The company emphasizes the potential of CardiAMP therapy to reduce healthcare costs associated with heart failure by improving patient health outcomes [7]
BioCardia(BCDA) - 2024 Q4 - Annual Results
2025-03-26 21:20
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]
BioCardia(BCDA) - 2024 Q4 - Annual Report
2025-03-26 21:18
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].
BioCardia Reports 2024 Business Highlights and Financial Results
Globenewswire· 2025-03-26 20:30
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].
BioCardia to Host 2024 Financial Results and Corporate Update Conference Call on March 31, 2025
Globenewswire· 2025-03-21 12:30
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]
BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System
Globenewswire· 2025-03-10 13:15
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]
BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions
Globenewswire· 2025-02-27 14:15
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]