Biocardia 2025 Q3 Earnings Narrowed Losses Amid Regulatory Progress

Biocardia (BCDA) reported its fiscal 2025 Q3 earnings on Nov 12, 2025, narrowing losses and advancing key regulatory milestones. The company’s results beat expectations with a 14.6% reduction in net loss compared to the prior year, despite ongoing financial challenges. Management highlighted progress in CardiAMP cell therapy trials and secured $6 million in funding, which analysts view as critical for regulatory submissions and clinical development.

Revenue

Biocardia’s total revenue remained stable at $0 in 2025 Q3, consistent with the prior-year period. The company has no revenue-generating operations at this stage, as it remains focused on clinical development and regulatory approvals for its cell therapy platforms.

Earnings/Net Income

The company narrowed its net loss to $-1.48 million in 2025 Q3, a 14.6% improvement from the $-1.74 million loss in 2024 Q3. Earnings per share also improved to -$0.24 from -$0.61. While the reduction in losses is positive, the sustained net loss over nine consecutive years underscores ongoing financial challenges that require continued capital raising and operational efficiency.

Price Action

Biocardia’s stock price declined 0.76% during the latest trading day, 1.52% in the past week, and 13.91% month-to-date. The decline reflects investor caution amid prolonged losses and the absence of near-term revenue visibility, despite regulatory progress in key trials.

Post-Earnings Price Action Review

The stock’s post-earnings performance highlights market skepticism about Biocardia’s ability to achieve profitability in the near term. While the company’s reduced losses and regulatory advancements in the CardiAMP HF II trial and Helix delivery system are encouraging, the lack of revenue and continued reliance on financing to fund operations weigh on investor sentiment. The 13.91% monthly decline underscores the need for concrete milestones, such as FDA or PMDA approvals, to reverse the downward trend.

CEO Commentary

Peter Altman, CEO of BioCardia, emphasized the $6 million financing as pivotal for advancing CardiAMP cell therapy discussions with the FDA and PMDA. He highlighted progress in the CardiAMP HF II trial, noting four active U.S. centers and consistent safety/benefit data from prior trials. Strategic priorities include leveraging the Helix platform for biologic heart therapy and securing non-dilutive funding for CardiALLO, while addressing regulatory and enrollment challenges.

Guidance

BioCardia outlined key milestones: PMDA consultation for CardiAMP HF in Q4 2025, FDA approvability meeting request in Q4 2025, and Helix 510(k) submission in Q4 2025. The company expects $5.3 million in cash as of Sept 30, 2025, providing runway into Q2 2026. Non-dilutive funding for CardiALLO is anticipated in Q1 2026, alongside regulatory and clinical timelines subject to delays.

Additional News

Recent developments include a $6 million financing round in September 2025, which bolstered cash reserves and supported regulatory submissions. BioCardia also announced a partnership with CART-Tech to develop Heart3D fusion imaging technology for cardiac interventions, enhancing precision in biologic therapy delivery. Additionally, the company secured a positive preliminary consultation with Japan’s PMDA for CardiAMP cell therapy, advancing its global regulatory strategy.

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