BioCardia, Inc.

BioCardia did not give revenue or EPS figures on the call. Net cash used in operations was approximately $1.7 million in Q2 2026 versus $1.6 million in Q2 2025, and $3.4 million for the first six months of 2026 versus $3.3 million a year earlier. Total expense fell to $1.6 million from $2.1 million in the prior-year quarter, driven mainly by R&D expense of $900,000 versus $1.4 million, while SG&A was $700,000. Net loss was $1.6 million versus $2.0 million in the prior-year quarter. The company raised approximately $4.9 million net through its ATM at an average price of $1.22 per share, ended the quarter with $5.4 million in cash and cash equivalents, and said that provides runway into 2027. Management also said equity was $2.7 million, which they believe keeps them compliant with Nasdaq listing standards. No formal next-quarter revenue or earnings guidance was provided; instead, the company said it expects to complete the PMDA submission for CARDIAMP, continue enrolling CardiAmp Heart Failure II, and work through FDA follow-up on Helix and the trial endpoint.

Peter Altman framed the quarter around three positive regulatory interactions: PMDA in Japan, FDA on CardiAmp Heart Failure II, and FDA on the Helix catheter. He said the company is preparing for a Japan Shonin submission and believes the remaining PMDA questions are manageable, while also characterizing FDA’s feedback as supportive enough to view HF II as a confirmatory trial. His tone was optimistic and strategic, emphasizing that approval in Japan could open a real market, help broader partnering, and potentially support additional geographies like Brazil and the UAE.

David McClung focused on disciplined spending and balance sheet stability. He said net cash used in operations was $1.7 million in Q2 and $3.4 million year to date, with the small increase mainly due to supplier-payment timing. He highlighted the $4.9 million net ATM raise at $1.22 per share, total cash of $5.4 million, runway into 2027, and equity of $2.7 million, which he said keeps the company compliant with Nasdaq standards. He also noted total expense declined to $1.6 million in Q2 from $2.1 million a year ago, with R&D down to $900,000 and SG&A flat at $700,000.

Analysts pressed on what still remains for FDA minutes on Helix, and Altman said the key open point is clarifying the de novo submission path; he stressed FDA had raised no concerns on safety and that approval of Helix alongside CardiAmp would be the easiest path for the agency. Questions on Japan focused on market expansion, reimbursement, and the DMAH structure: management said the DMAH is mainly a regulatory/quality representative, not the commercial owner, and that BioCardia expects to remain the seller in the post-marketing study. They also said the main data gap for PMDA is documentation on why a small number of patients were not on guideline-directed medical therapy, and that the longest remaining task may be CDISC formatting. On HF II enrollment, Altman said 4 centers are actively enrolling, more centers are interested, and the company is streamlining the trial while focusing on the primary endpoint.