Core Insights - BioCardia, Inc. has completed a third preliminary clinical consultation with Japan's PMDA regarding its CardiAMP Cell Therapy for treating Heart Failure with Reduced Ejection Fraction (HFrEF) [1] - The PMDA has indicated that BioCardia can proceed to formal clinical consultation, which may lead to regulatory approval in Japan if the data is deemed sufficient [1] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [5] - The company is headquartered in Sunnyvale, California, and focuses on developing autologous and allogeneic cell therapies [5] Product Development - CardiAMP Cell Therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to improve heart function [3] - The therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund [3] Clinical Trial Highlights - Phase 1: TABMMI Heart Failure Trial involved 20 patients [4] - Phase 2: TACHFT Trial included 33 patients, with 29 randomized [4] - Phase 3: CardiAMP HF Trial had 125 patients, with 115 randomized and a 24-month follow-up [4] - Key outcomes include a 90% survival rate at three years and a 7% improvement in left ventricular ejection fraction at 24 months (p=0.001) [4] - Treated patients showed a 20% reduction in major adverse cardiovascular events compared to controls [4] Efficacy Signals - A subgroup of randomized patients with elevated NTproBNP before enrollment (n=57) demonstrated strong efficacy signals [5] - Quality of life improved by 17.4 points (p=0.039) for treated patients compared to controls [4] Future Prospects - The ongoing regulatory discussions in Japan and the United States will determine the next steps for CardiAMP Cell Therapy [2][4]

Core Insights - BioCardia, Inc. has elected Mr. Marvin Slosman to its Board of Directors effective December 2, 2025, following the departure of Dr. Richard Krasno who completed his term on the same date [1][3]. Group 1: Board Changes - Mr. Marvin Slosman brings extensive expertise in interventional cardiology and a strong track record in advancing medical technologies from concept to commercialization [2]. - Dr. Richard Krasno has been recognized for his significant contributions during his tenure, including guiding the company through key milestones such as the development of clinical evidence for CardiAMP cell therapy and the FDA approval of Morph DNA [3][4]. Group 2: Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its main product platforms being CardiAMP and CardiALLO cell therapies [5]. - The company is currently developing three clinical stage product candidates, supported by its Helix biotherapeutic delivery and Morph vascular navigation product platforms [5].

Core Insights - BioCardia, Inc. is a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [2] - The company will present at the CSI Focus Devices in Heart Failure conference in Frankfurt, Germany, on December 5, 2025 [1] - The presentation will focus on "Intramyocardial Cell Therapy for Ischemic Heart Failure of Reduced Ejection" [1] Company Overview - BioCardia is headquartered in Sunnyvale, California, and specializes in biotherapeutic platforms, including CardiAMP® autologous and CardiALLO™ allogeneic cell therapies [2] - The company has three clinical stage product candidates in development, supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms [2] Event Details - The CSI Focus D-HF conference will cover advancements in device-based therapy for heart failure, including ventricle restoration strategies and monitoring systems [1] - The session featuring BioCardia's CEO will take place from 10:30 to 11:30 CET [1]

Core Insights - BioCardia, Inc. has appointed Farhan Shahab as Vice President of Quality, bringing over 25 years of experience in executive roles related to quality and regulatory affairs [1][2]. Company Overview - BioCardia is a global leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [1][3]. - The company has two main biotherapeutic platforms: CardiAMP® (autologous cell therapy) and CardiALLO™ (allogeneic cell therapy), with three clinical stage product candidates currently in development [3]. Leadership and Expertise - Farhan Shahab previously held significant roles at Welldoc, Intuity Medical, Moximed, and AngioScore, focusing on quality assurance and regulatory compliance [2]. - Shahab's expertise in product quality management and regulatory submissions is expected to enhance BioCardia's ability to commercialize its investigational products [3].

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Financial Data and Key Metrics Changes - Research and development expenses increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, and increased to $3.8 million for the nine months ended September 2025 from $3.0 million for the same period in 2024, driven by the closeout of the CardiAmp heart failure study and new enrollment in the CardiAmp heart failure II trial [14] - Selling general and administrative expenses decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and decreased to $2.4 million for the nine months ended September 2025 from $2.8 million for the same period in 2024, primarily due to lower compensation and professional services [15] - Net loss was $1.5 million for Q3 2025 compared to $1.7 million for Q3 2024, and $6.2 million for the nine months ended September 2025 compared to $5.5 million for the same period in 2024 [15] - Net cash used in operations decreased to $1.5 million in Q3 2025 from $1.7 million in Q3 2024, and for the nine months ended September 2025 decreased to $4.9 million from $5.5 million for the same period in 2024 [16] Business Line Data and Key Metrics Changes - The CardiAmp heart failure II clinical study is actively enrolling, with four centers currently involved and three having randomized their first patients [8][28] - The CardiAmp cell therapy in chronic myocardial ischemia trial showed an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes at the six-month primary endpoint [10] Market Data and Key Metrics Changes - Japan's PMDA has shown interest in heart failure therapies due to its aging population and limited options for treatment, which may enhance the market potential for the CardiAmp system [6][38] Company Strategy and Development Direction - The company is focused on advancing regulatory submissions for the CardiAmp cell therapy and Helix delivery system, with plans for a meeting with the FDA regarding the approvability of the CardiAmp system [7][13] - The company is pursuing non-dilutive funding for the CardiALLO allogeneic mesenchymal stem cell therapy, with expectations of clarity on funding in Q1 2026 [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the CardiAmp heart failure II program, citing strong clinical data and support from physicians involved in previous trials [28][38] - The company is in a waiting mode for formal clinical consultations with Japanese regulatory authorities, with most preparatory work completed [35] Other Important Information - The company ended the quarter with $5.3 million in cash, which is expected to provide a runway into Q2 2026 without additional financing [16] Q&A Session Summary Question: Clarification on CardiAmp CMI data - The CardiAmp CMI data includes five patients enrolled at their primary endpoint out to six months, with compelling results compared to previous data [18][19] Question: Recruitment challenges for CardiAmp heart failure II trial - Enrollment is proceeding smoothly, aided by cell population analysis to set dosages, with no significant challenges reported [23][24] Question: Next steps for Japanese regulatory approval - The key hurdle is a formal clinical consultation to determine if existing clinical data is sufficient for safety and efficacy in Japan [33][34]

Core Insights - BioCardia, Inc. reported its financial results for Q3 2025, highlighting ongoing developments in its cell therapy programs for cardiovascular diseases [1][2]. Financial Performance - The company closed a $6 million financing round, netting $5.2 million, which supports the approvability discussions for CardiAMP cell therapy and the submission for the Helix Transendocardial Delivery Catheter [2][5]. - Research and development expenses increased to $936,000 for Q3 2025 from $931,000 in Q3 2024, and for the nine months ended September 2025, expenses rose to $3.8 million from $3.0 million in the same period of 2024 [5]. - Selling, general and administrative expenses decreased to $552,000 in Q3 2025 from $825,000 in Q3 2024, and for the nine months ended September 2025, these expenses fell to $2.4 million from $2.8 million in the same period of 2024 [5]. - The net loss for Q3 2025 was $1.5 million, a decrease from $1.7 million in Q3 2024, while the net loss for the nine months ended September 2025 increased to $6.2 million from $5.7 million in the same period of 2024 [5][14]. Clinical Developments - CardiAMP autologous cell therapy showed promising results in patients with ischemic heart failure, with an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes at the six-month primary endpoint [3][4]. - The company is actively enrolling patients in the CardiAMP HF II phase 3 confirmatory trial, which focuses on patients with elevated biomarkers of heart stress [4][6]. - The Investigational New Drug application for CardiALLO allogeneic cell therapy is progressing, with no treatment-emergent adverse events reported in the low dose cohort [3][4]. Upcoming Milestones - Key upcoming milestones include the publication of roll-in cohort data for CardiAMP therapies in Q1 2026 and a request for a meeting with the FDA regarding the approvability of the CardiAMP system in Q4 2025 [6][8]. - The company anticipates a clinical review with Japan's PMDA for CardiAMP HF in Q4 2025, which could facilitate market entry in Japan [4][6]. Company Overview - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its primary platforms being CardiAMP autologous and CardiALLO allogeneic cell therapies [9].

Financial Performance - BioCardia reported a net loss of $1.5 million for Q3 2025, a decrease from $1.7 million in Q3 2024, primarily due to lower compensation expenses [10]. - Cash balance as of September 30, 2025, was $5.3 million, providing runway into Q2 2026 exclusive of additional capital [10]. - Total assets increased to $6.1 million as of September 30, 2025, compared to $3.7 million at the end of 2024 [16]. Research and Development - Research and development expenses increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, and rose to $3.8 million for the nine months ended September 2025, compared to $3.0 million for the same period in 2024 [7]. - The Helix transendocardial delivery system is set for DeNovo 510(k) submission for FDA approval in Q4 2025 [7]. - CardiAMP HF II phase 3 trial is currently enrolling patients with elevated biomarkers of heart stress [3]. Product Development and Regulatory - CardiAMP cell therapy for heart failure has shown statistical significance in primary outcomes in two completed randomized controlled trials [3]. - The company anticipates a meeting with the FDA regarding the approvability of the CardiAMP system in Q4 2025 [3]. - Top line primary outcomes from the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial indicated an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes [4]. Financing - The company closed a $6.0 million financing in September 2025, with net proceeds totaling $5.2 million [7].

Financial Performance - Net loss for the three months ended September 30, 2025, was $1,483 million, a decrease of 14.6% compared to a net loss of $1,737 million for the same period in 2024[14] - The company reported total revenue from collaboration agreements of $0 for the three months ended September 30, 2025, compared to $58 million for the same period in 2024[14] - Net cash used in operating activities for the nine months ended September 30, 2025, was $4,939 million, a decrease of 9.4% compared to $5,453 million in the same period of 2024[19] - Total stockholders' equity increased to $2,627 million as of September 30, 2025, from $837 million at December 31, 2024, representing a growth of 213.0%[11] Assets and Liabilities - Total assets increased to $6,148 million as of September 30, 2025, compared to $3,724 million at December 31, 2024, reflecting a growth of 65.0%[11] - Total liabilities rose to $3,521 million as of September 30, 2025, compared to $2,887 million at December 31, 2024, marking an increase of 21.9%[11] - Cash and cash equivalents at the end of the period were $5,287 million, an increase of 22.5% from $4,930 million at the end of September 2024[19] - The total cash and cash equivalents as of September 30, 2025, were $5.287 million, compared to $2.371 million as of December 31, 2024, indicating an increase[38] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $3,834 million, up 28.9% from $2,972 million in the same period of 2024[14] Capital Raising and Stock - The company raised $8,690 million from sales of common stock during the nine months ended September 30, 2025, compared to $10,513 million in the same period of 2024[19] - As of September 30, 2025, approximately $2.9 million of common stock may still be sold under the At-the-Market offering agreement[54] - For the three months ended September 30, 2025, the company sold 303,932 common shares, generating gross proceeds of $783,000[55] - The gross proceeds from the February 2024 Offering were $875,000, with associated issuance costs of $43,000[47] - The gross proceeds from the September 2024 Registered Offering were $7.2 million, with associated issuance costs of $926,000[49] Expenses and Liabilities - Accrued expenses and other current liabilities totaled $1.803 million as of September 30, 2025, up from $1.551 million as of December 31, 2024[44] - The depreciation expense for the nine months ended September 30, 2025, was $21,000, compared to $52,000 for the same period in 2024[39] - BioCardia's lease expense was $121,000 for both the three months ended September 30, 2025, and 2024, and $362,000 for both the nine months ended September 30, 2025, and 2024[42] - Total share-based compensation for the nine months ended September 30, 2025 was $345,000, compared to $565,000 for the same period in 2024[56] Going Concern - As of September 30, 2025, BioCardia had an accumulated deficit of approximately $166.4 million and cash and cash equivalents of approximately $5.3 million, raising substantial doubt about its ability to continue as a going concern beyond the second quarter of 2026[28] Stock Options and Warrants - As of September 30, 2025, the balance of outstanding warrants for common stock was 7,948,618, with a weighted average exercise price of $1.88[46] - As of September 30, 2025, the company had 164,900 stock options outstanding, with a weighted average exercise price of $48.17[59] Tax and Interest Rate Exposure - The company has a full valuation allowance on deferred tax assets, indicating uncertainty in generating future taxable income[61] - There was no income tax expense or benefit for federal or state income taxes during the three and nine months ended September 30, 2025 due to net loss[60] - The company does not currently hedge interest rate exposure, and a hypothetical 100 basis point change in interest rates would have an immaterial impact on operations[121]

Core Insights - BioCardia, Inc. has initiated the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial targeting ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - The CardiAMP HF II trial aims to confirm the safety and efficacy of the CardiAMP autologous cell therapy, which has shown promising results in previous studies despite not meeting the primary endpoint [2][3] - The trial is significant as it addresses a critical need for treatment options among the approximately 2 million patients in the U.S. and EU suffering from ischemic HFrEF [2][5] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics, focusing on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [7] - The company is developing two main biotherapeutic platforms: CardiAMP autologous and CardiALLO allogeneic cell therapies, with three clinical stage product candidates [7] - The CardiAMP Cell Therapy has received FDA Breakthrough designation and is designed to treat microvascular dysfunction by using a patient's own bone marrow cells [5][7] Clinical Trial Details - The CardiAMP HF II study is a randomized, multicenter, placebo-controlled trial involving 250 patients, focusing on those with elevated NTproBNP levels [3] - The primary outcome measure includes all-cause death, nonfatal major adverse cardiac events, and a validated quality of life measure, similar to the previous CardiAMP HF study [3] - Advances in the trial include improved cell population analysis for treatment dosing and enhancements to the Helix system, including the FDA-approved Morph DNA steerable platform [4][5]