BioCardia (BCDA) Q2 2025 earnings summary

Executive summary

• CardiAMP Heart Failure trial showed reduced all-cause deaths and non-fatal MACE over 24 months, with significant benefit in patients with elevated NT-proBNP; pivotal CardiAMP HF II trial enrollment is ongoing and two-year data have been submitted to regulators in Japan and the US.

• Advanced regulatory submissions and discussions are underway in Japan (PMDA) and the US (FDA) for CardiAMP and Helix systems, with key meetings expected in Q4 2025.

• Active partnering discussions are ongoing for Helix, MorphDNA, and CardiALLO platforms, with a focus on non-dilutive funding and value creation.

• Multiple financing rounds completed in 2025 to support operations, but cash runway only extends to October 2025 without additional funding.

• Strengthened IP portfolio with a new US patent for the Helix delivery catheter.

Financial highlights

• Research and development expenses rose to $1.4M in Q2 2025 from $0.8M in Q2 2024, driven by trial closeout and regulatory activities.

• Selling, general, and administrative expenses decreased to $0.7M in Q2 2025 from $0.9M in Q2 2024, with six-month SG&A flat at $1.9M.

• Net loss was $2.05M for Q2 2025, up from $1.65M in Q2 2024; six-month net loss was $4.8M versus $3.9M year-over-year.

• Cash and equivalents at quarter-end were $980,000, with a post-ATM balance of $1.1M, providing runway into October 2025.

• Revenue was $0 in Q2 2025, down from $3,000 in Q2 2024; $0 for the first half of 2025, down from $58,000 year-over-year.

Outlook and guidance

• Anticipates modest R&D expense increase in 2025 as programs advance in the US and Japan.

• Expects SG&A expenses to remain consistent with 2024 levels.

• Regulatory clarity from PMDA expected by end of Q4 2025; FDA clarity to follow Helix de novo 510(k) submission.

• Financing event anticipated in September 2025, aiming for minimal dilution and shareholder benefit.

• Management expects continued operating losses and negative cash flows for several years as clinical programs advance.