BioCardia (BCDA) investor relations material

Executive summary

• Advanced regulatory submissions for CardiAMP cell therapy and Helix delivery system, with ongoing discussions with FDA and Japan's PMDA for market approval in heart failure indications.

• CardiAMP Heart Failure II Phase III trial is accelerating, with four centers enrolling and additional sites onboarding; trial design leverages prior positive data and improved patient selection.

• CardiAMP cell therapy for chronic myocardial ischemia showed improved exercise tolerance and reduced angina in trial patients; results being prepared for publication.

• CardiALLO allogeneic cell therapy phase 1/2 trial advanced with no safety concerns in the low dose cohort; Phase 2 development planned in the US and Japan.

• Partnership with CART-Tech to develop Heart3D Fusion Imaging for biotherapeutic delivery, with promising preclinical results and clinical advancement planned for 2026.

Financial highlights

• Net loss for Q3 2025 was $1.5 million, down from $1.7 million in Q3 2024; net loss for nine months ended September 2025 was $6.2 million, up from $5.7 million year-over-year.

• Research and development expenses rose to $936,000 in Q3 2025 from $931,000 in Q3 2024, and to $3.8 million for the nine months ended September 2025 from $3.0 million in the prior year period.

• Selling, general and administrative expenses decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and to $2.4 million for the nine months ended September 2025 from $2.8 million in the prior year.

• Cash and cash equivalents at September 30, 2025, were $5.3 million, providing runway into Q2 2026.

• Accumulated deficit reached $166.4 million as of September 30, 2025.

Outlook and guidance

• Cash on hand projected to fund operations into Q2 2026 without additional financing; additional capital will be required for operations beyond that.

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

• SG&A expected to remain close to 2024 levels.

• Expect Japan PMDA clinical review and FDA meeting request for CardiAMP in Q4 2025; peer-reviewed publications and further trial enrollment milestones in 2026.

• Plans to raise capital through equity, debt, or non-dilutive arrangements; failure to secure funding may require cost reductions or program delays.