BioCardia (BCDA) Q3 2026 earnings summary

Executive summary

• CardiAMP Japan application-material requirements were completed in November 2026 after PMDA consultation; the Shonin submission is targeted for Q4 2026/Q1 2027.

• FDA accepted the revised Helix De Novo Pre-Submission; feedback was expected within 70 calendar days.

• CardiAMP HF II was recruiting at four sites, with seven additional sites onboarding; no known safety issues were reported.

Financial highlights

• Q3 2026 net loss was $1.817M versus $1.483M in Q3 2025; 9M net loss was $5.689M versus $6.244M.

• Q3 R&D expense was $1.235M versus $936K; 9M R&D was $3.363M versus $3.834M, reflecting trial closeout partly offset by HF II enrollment and Japan regulatory work.

• Q3 SG&A was $600K versus $552K; 9M SG&A was $2.361M versus $2.431M.

• Q3 operating loss was $1.835M versus $1.488M; 9M operating loss was $5.724M versus $6.265M.

Outlook and guidance

• Japan Shonin submission is targeted for Q4 2026/Q1 2027; approval is expected 12 months after submission.

• Helix De Novo submission is expected in Q1 2027, with approval targeted for mid-2027 if FDA meets its 150-day review goal.

• September 30 cash of $2.224M was expected to fund planned expenditures and obligations only through January 2027; additional capital is needed beyond then.

• Planned funding options include collaborations or licensing, debt, equity, or a combination; R&D spending is expected to rise as pivotal trials and allogeneic programs advance, subject to funding.

• Heart3D FDA submission and a partner gene therapy study using Helix and Heart3D are targeted for Q1 2027.