Earnings Releases·Nov 12, 2026, 4:11 PM ET

BioCardia — Third Quarter 2026 Earnings Summary

Net loss increased to $1.8 million for the three months ended September 30, 2026, from $1.5 million in the prior year period, while the nine-month net loss decreased to $5.7 million from $6.2 million; cash and cash equivalents totaled $2.2 million at quarter-end, providing a runway into 2027.
The company expects to submit the CardiAMP Cell Therapy application to Japan's PMDA in Q4 2026 or Q1 2027, with the CardiAMP HF II trial actively enrolling across four sites with seven additional sites onboarding.
Regulatory milestones for the Helix Biotherapeutic Delivery System include a De Novo submission targeted for Q1 2027 with approval aimed for mid-2027, alongside anticipated FDA submissions for the Heart3D system and a gene therapy study in Q1/Q2 2027.
R&D expenses rose to $1.2 million in the quarter from $936,000 year-over-year, while SG&A increased to $600,000 from $552,000; total assets declined to $3.071 million from $3.413 million as of December 31, 2025.