BioCardia(US:BCDA)2025-11-12 21:10Financial 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].