BioCardia (BCDA) Q1 2026 earnings summary

Executive summary

• Achieved significant regulatory progress for CardiAMP cell therapy in Japan and the US, with positive feedback from PMDA and FDA on safety and efficacy data for ischemic heart failure and ongoing confirmatory trials.

• CardiAMP Heart Failure pivotal trial showed statistically significant improvements in heart function and quality of life for patients with elevated biomarkers.

• Advanced Helix Biotherapeutic Delivery System toward FDA approval, with agency support for simultaneous clearance with CardiAMP.

• Intellectual property portfolio strengthened with a new Japanese patent for Heart3D Fusion Imaging software.

• All four catalysts from the previous quarter were delivered, including three positive regulatory interactions.

Financial highlights

• Net loss for Q1 2026 was $2.26 million, compared to $2.71 million in Q1 2025.

• Research and development expenses decreased to $1.2 million from $1.5 million year-over-year, mainly due to trial closeout.

• Selling, general, and administrative expenses fell to $1.0 million from $1.2 million year-over-year.

• Cash and cash equivalents at quarter-end were $951,000, insufficient to fund operations beyond June 2026.

• Net cash used in operations was $1.7 million, slightly higher than $1.6 million in Q1 2025.

Outlook and guidance

• Preparing formal Shonin pre-market application in Japan, expected to take seven months for submission and about a year for review.

• Additional capital is required to fund operations beyond June 2026; options include equity, debt, grants, or partnerships.

• Anticipates completing transactions in Q2 2026 to fund Japan submission and CardiAMP HF II trial.

• Expects initial Japanese market to be around 20,000 patients, with a potential $400 million market opportunity at current U.S. reimbursement rates.

• Ongoing CardiAMP HF II trial continues as confirmatory study for US PMA submission.