BioCardia (BCDA) Q4 2025 earnings summary

Executive summary

• CardiAMP HF II trial advanced with four active enrollment centers and ongoing regulatory discussions in the US and Japan, targeting ischemic heart failure and refractory angina.

• CardiAMP HF I and phase III trials showed reduced adverse events, improved quality of life, and significant benefits in patients with elevated biomarkers.

• CardiALLO allogeneic cell therapy low dose cohort completed with no adverse events; Phase 2 development planned in the US and Japan.

• Helix delivery system FDA Pre-Submission accepted, with review scheduled for Q2 2026.

• Regulatory engagement ongoing with FDA and Japan's PMDA for potential approvals, with imminent Q-Submission and PMDA consultation.

Financial highlights

• Total expenses rose 3% year-over-year to $8.3 million in 2025, mainly due to increased R&D spending, with R&D expenses at $5 million and SG&A at $3.3 million.

• Net loss increased to $8.2 million in 2025 from $7.9 million in 2024.

• No revenue in 2025, compared to $58,000 in 2024.

• Cash and equivalents at year-end were $2.5 million, nearly unchanged from the prior year.

• Net cash used in operations was $7.5 million, down from $7.9 million the previous year.

Outlook and guidance

• R&D expenses expected to increase modestly in 2026 as clinical programs advance in the US and Japan.

• SG&A expenses projected to remain near 2025 levels.

• Cash burn anticipated to be consistent in 2026, with continued focus on resource management.

• Four near-term catalysts: FDA Q-Submission for CardiAMP, PMDA consultation in Japan, FDA feedback on Helix system, and EuroPCR presentation.

• Plans to fund CardiALLO MSC program through grants and partnerships, pending SBIR/STTR reauthorization.