Biocardia 2025 Q3 Earnings Narrowed Losses and Regulatory Progress

Biocardia (BCDA) reported its fiscal 2025 Q3 earnings on Nov 12, 2025, narrowing losses while advancing key regulatory milestones. The company reduced its net loss by 14.6% year-over-year to $-1.48 million and improved its per-share loss by 60.7% to $-0.24. Despite these improvements, the stock fell 0.76% in the latest session, reflecting ongoing market skepticism.

Revenue

Biocardia’s total revenue remained stable at $0 in 2025 Q3, unchanged from the prior-year period. The company, still in early-stage development, derives no revenue from its core operations as it focuses on advancing its cell therapy pipeline.

Earnings/Net Income

Biocardia narrowed its net loss to $-1.48 million in Q3 2025, a 14.6% reduction from the $-1.74 million loss in Q3 2024. The per-share loss improved by 60.7% to $-0.24 from $-0.61. While these adjustments reflect tighter cost management and capital raising, the company has sustained losses for nine consecutive years in this quarter, underscoring persistent financial challenges.

Price Action

Biocardia’s stock price declined 0.76% during the latest trading day, 1.52% over the past week, and 13.91% month-to-date. The post-earnings sell-off contrasts with the company’s improved financial metrics, suggesting market overreaction to broader risks, including regulatory hurdles and competitive pressures.

Post-Earnings Price Action Review

The strategy of buying Biocardia shares following an earnings beat and holding for 30 days has shown potential, driven by the company’s focus on heart failure therapies and insider confidence. Peter Altman, CEO, purchased $60,000 of BCDA shares at a 13% premium, signaling optimism. Post-earnings, the stock’s decline into oversold territory (per RSI) may have created a buying opportunity, though the market remains cautious about the company’s long-term viability. Biocardia’s CardiAmp cell therapy, with FDA breakthrough designation, and its regulatory submissions in the U.S. and Japan position it to benefit from favorable market sentiment if clinical and regulatory milestones are met. However, the company’s weak financial health, despite recent capital raises, remains a headwind. Historical performance suggests a 30-day holding period could yield returns if market sentiment rebounds or regulatory progress accelerates.

CEO Commentary

CEO Peter Altman highlighted the $6 million financing as critical for advancing CardiAMP cell therapy approvals, submitting the Helix delivery catheter via DeNovo 510(k), and supporting the CardiAMP HF II trial. He expressed optimism about transformative growth in the next two quarters, driven by regulatory milestones and clinical progress. Strategic priorities include securing FDA and PMDA approvals, expanding CardiAMP’s clinical validation, and leveraging the Helix platform for biologic therapies.

Guidance

Biocardia outlined key milestones: submission of the Helix DeNovo 510(k) by Q4 2025, PMDA review for CardiAMP HF in Japan by Q4 2025, and an FDA meeting on approvability of the CardiAMP System in Q4 2025. The CardiAMP HF II trial’s top-line data is expected in Q1 2026. The company expects its cash runway to extend into Q2 2026, excluding additional capital. Forward-looking statements include anticipated regulatory interactions, clinical trial progress, and potential non-dilutive funding for CardiALLO by Q1 2026.

Additional News

Within three weeks of the earnings report, Biocardia secured a $6 million financing round, bolstering its cash position to $5.3 million. The company also announced the enrollment of first patients in the CardiAMP HF II trial at Henry Ford Health and the University of Wisconsin, signaling progress in expanding its clinical network. Additionally, Biocardia partnered with CART-Tech to develop Heart3D fusion imaging, enhancing precision in cardiac interventions. These developments underscore the company’s strategic focus on regulatory and clinical advancements to drive long-term value.