Summary of BioCardia Q2 2026 Earnings Call

1Key Financial Results and Metrics

Net Cash Used in Operations: Approximately $1.7 million for Q2 2026, slightly up from $1.6 million in Q2 2025. For the first half of 2026, net cash used was $3.4 million, compared to $3.3 million in the same period of 2025.

Net Loss: Reported at $1.6 million for Q2 2026, down from $2 million in Q2 2025. The six-month net loss was $3.9 million, compared to $4.9 million in the prior year.

Cash Position: Ended Q2 2026 with $5.4 million in cash and equivalents, providing a runway into 2027.

Funding: Raised approximately $4.9 million through an at-the-market facility at an average price of $1.22 per share.

2Strategic Updates and Business Highlights

Regulatory Progress: Positive outcomes from meetings with regulatory agencies in Japan and the U.S. regarding the approval of the CARDiAmp cell therapy and HELIX transendocardial delivery catheter.

Japan's PMDA supports advancing to Shonin premarket submission for CARDiAmp, with an expected initial indication for about 20,000 patients.

FDA indicated that the ongoing CardiAmp Heart Failure II trial may support premarket approval, viewing it as a confirmatory trial.

Market Potential: The approval of a competing cell therapy in Japan at $326,000 per treatment highlights the market opportunity for BioCardia, with potential rapid adoption expected post-approval.

Business Development: Active discussions in the Asia Pacific region and potential partnerships to enhance efforts for CardiAmp and other therapies.

3Forward Guidance and Outlook

Regulatory Submissions: Anticipated Shonin submission in Japan within the next 12 months, with a focus on physician education and post-marketing study logistics.

Market Expansion: Potential for expanding the initial indication beyond 20,000 patients based on successful post-marketing study results and physician engagement.

Future Financing: Plans for modest financing to accelerate the confirmatory CardiAmp Heart Failure II program.

4Bad News, Challenges, or Points of Concern

Regulatory Hurdles: The need to address specific PMDA requests regarding patient eligibility and guideline-directed medical therapy compliance could delay the Shonin submission timeline.

Enrollment Challenges: Current enrollment in the CardiAmp Heart Failure II trial is slower than desired, with ongoing efforts to onboard additional clinical sites.

Market Competition: The competitive landscape includes other companies with similar therapies, which may impact market share and pricing strategies.

5Notable Q&A Insights

FDA Submission Clarifications: The FDA's preference for simultaneous approval of the HELIX catheter with the CARDiAmp therapy was emphasized, with ongoing discussions to clarify submission requirements.

Market Dynamics in Japan: The potential for rapid adoption of CARDiAmp in Japan was discussed, with a focus on the unique advantages of autologous cell therapy compared to surgical alternatives.

DMAH Partnership: The role of the designated marketing authorization holder (DMAH) was clarified as primarily regulatory, allowing BioCardia to maintain control over sales and distribution in Japan. Overall, BioCardia is making significant strides in regulatory approvals and market positioning, while also navigating challenges related to clinical trial enrollment and regulatory requirements.