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SEC filingOperating and net losses narrowed meaningfully year-over-year, reflecting disciplined cost control in SG&A, but BioCardia remains unprofitable with no near-term path to positive cash flow — its ability to continue as a going concern depends entirely on raising additional capital.
Net cash used in operating activities was -$1.7M in Q1 FY2026, compared to -$1.6M in Q1 FY2025. Management attributes this modest increase to the timing of payments to suppliers — not deterioration in underlying operations. Capital expenditures totaled only $3,000, reinforcing the company’s focus on clinical execution over capital-intensive infrastructure. Free cash flow — defined as operating cash flow less capital expenditures — was therefore -$1.7M, unchanged in substance from operating cash flow given the immaterial capex.
The Yale core laboratory measured both left ventricular end diastolic volume (p = 0.06) and left ventricular end systolic volume (p = 0.09), supporting continued evaluation of CardiAMP’s biological signal. PMDA’s alignment on the Japan Shonin submission — including acceptance of U.S. data and agreement on post-marketing requirements — marks the first tangible regulatory pathway toward potential commercialization. FDA has likewise confirmed PMA remains the U.S. approval pathway and remains open to advancing submission based on existing data. These developments are critical near-term catalysts — but they do not alter the fundamental reality that no revenue from cell therapies is expected until regulatory approval, and the next capital raise must bridge multiple years of continued losses.