BioCardia Reports Third Quarter 2025 Business Highlights and Financial Results

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].