BioCardia (BCDA 0.28%), a clinical-stage cell therapy company focused on treatments for heart disease, released its financial results for the second quarter of 2025 on August 11, 2025. The company reported no revenue for the period and a net loss per share of $(0.40) (GAAP), narrower than the estimated loss of $(0.50). The quarter was marked by sharply higher research and development costs, declining assets, cash constraints, and steady progress in its pipeline of cell-based therapeutics. While the financial results reflected the typical pressures seen in pre-commercial biotech firms, the company made clinical progress in its core cardiovascular programs and advanced regulatory submissions both in the United States and Japan.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.40) | $(0.50) | $(0.88) | N/A |
| Revenue (GAAP) | $0 | $0 | $3,000 | (100.0%) |
| Research and Development Expense | $1,368,000 | $800,000 | 71.0% | |
| Selling, General and Administrative Expense | $683,000 | $852,000 | -19.8% | |
| Net Cash Used in Operations | $1,600,000 | $1,300,000 | 23.1% |
Source: Analyst estimates for the quarter provided by FactSet.
Company Overview and Strategic Focus
BioCardia specializes in regenerative medicine for cardiovascular diseases, developing cell therapy platforms to treat heart failure and chronic myocardial ischemia. Its key assets include the CardiAMP autologous cell therapy system for ischemic heart failure and chronic myocardial ischemia, CardiALLO allogeneic mesenchymal stem cell therapy, and biotherapeutic delivery devices such as the Helix system.
The company's near-term strategy centers on advancing its late-stage clinical trials, winning regulatory approvals in the United States and abroad, and establishing commercial partnerships. Success depends on positive trial outcomes, regulatory acceptance, intellectual property strength, and a favorable reimbursement landscape for its therapies—factors that are especially important given low or no revenues and pressure from increasing development costs and capital needs.
Quarter Highlights and Developments
The quarter saw the culmination of major clinical milestones for BioCardia's pipeline. In March 2025, two-year outcomes from the pivotal double-blind CardiAMP Phase 3 trial for ischemic heart failure were presented at the American College of Cardiology's Annual Scientific Session. The therapy led to increased survival and fewer cardiac events over two years for treated patients in a high-risk subgroup defined by elevated NTproBNP, as demonstrated in the double-blind, randomized, placebo-controlled Phase 3 CardiAMP HF Trial. However, statistical significance was reached only in a high-risk subgroup defined by elevated NTproBNP, a biomarker of heart stress (p=0.02), based on two-year results from the Phase 3 CardiAMP HF Trial presented earlier in 2025 rather than in the overall trial population in the 24-month CardiAMP HF study (p=0.17).
BioCardia also progressed its CardiAMP HF II confirmatory trial, enrolling patients at four sites and focusing on those with active heart stress—the group that responded best in the original study. The confirmatory trial's design includes refined eligibility screening, improved delivery technology with the Morph DNA steerable catheter, and revised endpoints to address prior challenges. Medicare covers both treatment and control arms under code C9782 at $17,500 per patient, according to BioCardia management, which reduces net research expenses.
The company also reported promising results in its open-label CardiAMP cohort for chronic myocardial ischemia, another advanced heart condition. Patients experienced a 107-second average increase in exercise tolerance at the primary six-month follow-up endpoint compared to before receiving the study treatment and an average 82% reduction in angina episodes at the primary six-month follow-up endpoint. These results, though encouraging, are from a small, uncontrolled group and will guide further study design and regulatory conversations.
Progress continued with CardiALLO, an allogeneic off-the-shelf cell therapy for ischemic heart failure. The low-dose cohort in the Phase 1/2 trial showed no serious safety issues, and an independent monitoring board recommended the study move forward. Looking further, the company is planning to scale up the trial to higher cell doses and conduct a randomized controlled study. On the device side, BioCardia prepared an FDA submission for its Helix delivery system, targeting the third quarter of 2025.
Financial Performance and Operating Trends
The company reported no revenue for the quarter, matching the forecast and reflecting its current pre-commercial state. The prior year's modest revenue of $3,000 (GAAP) came from collaboration agreements, and no new collaborations produced income this period. Research and development costs rose significantly due to higher expenses for trial closeouts and the initiation of the CardiAMP HF II trial.
Selling, general, and administrative costs fell to $683,000, compared to $852,000 a year earlier. The reduction came from lower professional fees and stock-based compensation. Net cash used in operations increased 23.1% from Q2 2024, reaching $1.6 million, which put additional strain on a shrinking cash reserve. Cash stood at $980,000 as of June 30, 2025. A subsequent $769,000 raised through an at-the-market stock program from July 1, 2025 to August 8, 2025 brought the balance to $1.1 million—only enough to fund operations into October 2025.
On the balance sheet, total assets (GAAP) declined from $3.7 million as of December 31, 2024 to $2.1 million as of June 30, 2025, while current liabilities rose from $2.3 million as of December 31, 2024 to $3.6 million as of June 30, 2025, resulting in a negative stockholders' equity position of $(1.89) million (GAAP) as of June 30, 2025. This underscores both the company's capital needs and its dependence on timely financing or partnerships.
The company strengthened its intellectual property portfolio this quarter by securing a new U.S. patent for its catheter platform, supporting its competitive position. Management highlighted ongoing engagement with the FDA and Japan's PMDA, emphasizing a plan to submit key trial data for discussions during the second half of the year. The company maintains that both U.S. and Japanese pathways represent important opportunities, citing large American and international markets for heart failure therapies and a focus on patient groups most likely to benefit.
Outlook and Guidance
No formal revenue or earnings guidance for coming quarters was provided by management. Instead, the focus remains on imminent clinical, regulatory, and business milestones such as the FDA Helix submission, regulatory meetings on CardiAMP in both the United States and Japan, and advancing trial enrollment and data readouts in 2025 and early 2026. Leadership highlighted the Medicare reimbursement now available for study participants, which partially offsets future research costs, and ongoing pursuit of commercial and distribution partnerships.
Looking forward, investors will need to watch several key inflection points, including the acceptance of CardiAMP trial data by regulators, progress in trial enrollment, and updates on cash management. The company's very limited cash runway and continued operating losses heighten funding risk, and any further capital raises could bring more dilution.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
