BioCardia(BCDA) - 2025 Q2 - Quarterly Results

Recent Business Highlights BioCardia reported significant Q2 2025 progress across its therapeutic pipeline, advancing CardiAMP HF, CardiAMP CMI, and CardiALLO programs CardiAMP Autologous Cell Therapy in Ischemic Heart Failure (BCDA-01) Two-year Phase 3 CardiAMP HF trial results showed positive trends, leading to regulatory discussions in Japan and the U.S - Two-year Phase 3 CardiAMP HF Trial results indicated a lower incidence of all-cause death and non-fatal MACCE in the treatment group over 24 months (p=0.17)[2] - The composite endpoint, including quality of life, was statistically significant (p=0.02) in the elevated NTproBNP patient subgroup[2] - Trial data submitted to Japan's PMDA, with Q4 2025 meetings planned for market entry discussions and similar FDA meetings regarding approvability[2] - The confirmatory CardiAMP HF II Phase 3 trial is actively enrolling U.S. patients, with $17,500 Medicare reimbursement per patient offsetting study costs[2] CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia (BCDA-02) The BCDA-02 roll-in cohort for chronic myocardial ischemia showed significant improvements in exercise tolerance and angina episodes - Patients in the roll-in cohort showed an average 107-second increase in exercise tolerance at six months[3] - Patients experienced an average 82% reduction in angina episodes compared to baseline[3] CardiALLO Allogeneic Cell Therapy in Ischemic Heart Failure (BCDA-03) The CardiALLO (BCDA-03) Phase 1/2 low-dose cohort completed safely, with no adverse events, and the study was recommended to proceed - The low-dose cohort (20 million cells) of the Phase 1/2 trial completed with no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses[4] - The Data Safety Monitoring Board reviewed 30-day safety data and recommended the study proceed as designed in April 2025[4] Helix Biotherapeutic Delivery and Intellectual Property BioCardia plans a Q3 2025 DeNovo 510(k) submission for its Helix delivery system and secured a new patent for its catheter technology - The company intends to submit the Helix transendocardial system for DeNovo 510(k) approval in Q3 2025[5] - U.S. Patent No. 12,311,127 was granted, protecting the company's core delivery technology for radial and trans-endocardial catheters[6] Second Quarter 2025 Financial Results BioCardia reported a net loss of $2.05 million in Q2 2025, an increase from $1.65 million in Q2 2024, driven by higher R&D expenses Q2 2025 vs Q2 2024 Financial Highlights (in thousands) | Financial Metric | Q2 2025 ($ thousands) | Q2 2024 ($ thousands) | Change ($ thousands) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $1,400 | $800 | +$600 | CardiAMP HF Trial closeout and CardiAMP HF II enrollment start | | Selling, General & Admin | $700 | $900 | -$200 | Lower professional fees and share-based compensation | | Net Loss | $2,000 | $1,600 | +$400 | Increased R&D expenses | | Net Cash Used in Ops | $1,600 | $1,300 | +$300 | Increased trial activities | - Cash balance was approximately $980,000 as of June 30, 2025[7] - Post-quarter end, the company raised $769,000 in gross proceeds from its ATM program, increasing the cash balance to approximately $1.1 million, providing a runway into October 2025[7] Condensed Consolidated Statements of Operations The company reported a net loss of $2.05 million for Q2 2025 and $4.76 million for the six months ended June 30, 2025 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenue | $— | $3 | $— | $58 | | Costs and expenses: | | | | | | Research and development | 1,368 | 800 | 2,898 | 2,041 | | Selling, general and administrative | 683 | 852 | 1,879 | 1,941 | | Total costs and expenses | 2,051 | 1,652 | 4,777 | 3,982 | | Operating loss | (2,051) | (1,649) | (4,777) | (3,924) | | Net loss | $(2,049) | $(1,646) | $(4,761) | $(3,913) | | Net loss per share, basic and diluted | $(0.40) | $(0.88) | $(0.98) | $(2.20) | | Weighted-average shares | 5,059,736 | 1,877,069 | 4,848,922 | 1,776,305 | Condensed Consolidated Balance Sheets As of June 30, 2025, BioCardia reported total assets of $2.09 million, total liabilities of $3.98 million, and a stockholders' deficit Condensed Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $980 | $2,371 | | Total assets | $2,089 | $3,724 | | Liabilities and Stockholders' Equity (Deficit) | | | | Current liabilities | $3,642 | $2,321 | | Total stockholders' equity (deficit) | $(1,886) | $837 | | Total liabilities and stockholders' equity (deficit) | $2,089 | $3,724 | Anticipated Upcoming Milestones and Events BioCardia has outlined key upcoming milestones, including Helix FDA submission, CardiAMP HF regulatory meetings, and CardiALLO funding Upcoming Milestones | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | Helix Delivery System | FDA Submission for Approval | Q3 2025 | | BCDA-01 (CardiAMP HF) | Manuscript Publication | Q4 2025 | | BCDA-01 (CardiAMP HF) | Japan PMDA Clinical Review | Q4 2025 | | BCDA-01 (CardiAMP HF) | FDA Meetings on Approvability | Q4 2025 | | BCDA-01 (CardiAMP HF) | CardiAMP HF II Enrollment | Ongoing | | BCDA-02 (CardiAMP CMI) | Top-line Data from Roll-in Cohort | Q4 2025 | | BCDA-03 (CardiALLO HF) | Nondilutive Funding | Q1 2026 |