BioCardia (BCDA) Q2 2026 earnings summary

Executive summary

• Achieved positive regulatory outcomes in Japan and the US for CardiAMP Cell Therapy and Helix catheter, with ongoing clinical trials and regulatory engagement for both CardiAMP and CardiALLO platforms.

• Preparing for Shonin pre-market submission in Japan, targeting initial approval for 20,000 patients and anticipating rapid adoption post-reimbursement.

• Presented positive two-year clinical outcomes for CardiAMP in refractory angina at EuroPCR.

• Business development efforts are active globally, with potential for partnerships and expansion into new indications and geographies.

• Modest revenues from approved products; operations primarily funded through equity sales and grants.

Financial highlights

• Net loss for Q2 2026 was $1.6M, improved from $2.0M in Q2 2025; six-month net loss was $3.9M, down from $4.8M year-over-year.

• Research and development expenses decreased to $0.9M in Q2 2026 from $1.4M in Q2 2025, mainly due to trial closeouts.

• Cash and cash equivalents were $5.4M at end of Q2 2026, providing runway into 2027.

• Raised $5.1M in Q2 2026 through ATM equity sales and private placements.

• Selling, general, and administrative expenses remained stable at $0.7M for Q2 2026.

Outlook and guidance

• Shonin submission in Japan expected next quarter, with approval anticipated about 12 months after submission.

• Current cash is not sufficient to fund operations beyond January 2027; additional capital will be required.

• Reimbursement discussions in Japan to follow approval, with pricing expectations supported by recent peer therapy reimbursement at $326,000 per treatment.

• US CardiAMP Heart Failure II Trial enrollment ongoing, with plans to streamline trial and focus on primary outcome measures.

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