BioCardia — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss was $1.8 million for the three months ended September 30, 2026, compared to $1.5 million for the same period in 2025.
• Net loss decreased to $5.7 million for the nine months ended September 30, 2026, compared to $6.2 million for the nine months ended September 30, 2025.
• Net cash used in operations was $1.7 million for the three months ended September 2026, comparable to $1.7 million for the three months ended September 2025.
• Net cash used in operations increased to $5.1 million for the nine months ended September 2026, compared to $4.9 million for the nine months ended September 2025.
• Research and development expenses increased to $1.2 million for the three months ended September 2026 from $936,000 in the same period in 2025.
• Research and development expenses decreased to $3.4 million for the nine months ended September 2026 from $3.8 million in the same period in 2025.
• Selling, general and administrative expenses increased to $600,000 for the three months ended September 30, 2026, from $552,000 in the same period in 2025.
• Selling, general and administrative expenses remained consistent at $2.4 million for the nine months ended September 30, 2026 and 2025.
• Cash and cash equivalents totaled $2.2 million at the end of the quarter, providing a runway into 2027.
• Total assets were $3.071 million as of September 30, 2026, compared to $3.413 million as of December 31, 2025.
• Total stockholders' equity was $835,000 as of September 30, 2026, compared to $895,000 as of December 31, 2025.

Guidance and Future Outlook:

• The company expects to submit the CardiAMP Cell Therapy Shonin application to Japan's PMDA in Q4 2026 or Q1 2027.
• The company aims to submit the Helix transendocardial delivery system for FDA approval in the coming months.
• The company expects to complete the De Novo submission for the Helix system in the first quarter of 2027, with approval targeted for mid-2027 if FDA meets its 150-day review goal.
• The Heart3D FDA submission is anticipated in Q1 2027.
• A gene therapy study using Helix and Heart3D is expected in Q1/Q2 2027.
• The CardiAMP HF Trial peer-reviewed manuscript is expected in Q1 2027.

Business Segments and Product Lines:

• CardiAMP Autologous Cell Therapy: Successfully completed the process with Japan's PMDA regarding application materials; remaining questions have been addressed to PMDA's satisfaction. The company is preparing clinical data sets for submission to Japan's PMDA and U.S. FDA, engaging a Designated Marketing Authorization Holder (DMAH) for Japan. The CardiAMP HF II trial is actively enrolling with four clinical sites and seven additional sites being onboarded.
• Helix Biotherapeutic Delivery System: FDA accepted minutes from the Q2 Pre-Submission Meeting for De Novo approval in August without changes. A revised Pre-Submission was submitted in September and accepted in October, with written feedback or a meeting expected within 70 calendar days. The system is positioned as a potential leading development platform for biologic therapies to treat heart disease.
• Heart3D Fusion Imaging: An investigational system enhancing real-time 2D X-ray imaging by fusing pre-procedure 3D anatomical heart models. The company is working with partner CART-Tech to perform studies with CardiAMP Cell Therapy and gene therapy partners to advance the platform into the clinic in 2027.

Market and Competitive Landscape:

• The company positions CardiAMP as potentially the first approved minimally invasive biologic therapy for heart failure in a first-world country.
• The Helix system is expected to be the first delivery system of its type approved in the United States.
• The Helix system has potential to become the leading development platform for biologic therapies to treat heart disease, offering efficient delivery and control for investigational agents.

Risks and Challenges:

• Forward-looking statements are subject to risks including inherent uncertainties in developing new products, regulatory approvals, and unexpected expenditures.
• Challenges include the ability to raise additional funding, enter licensing and partnering arrangements, and overall market conditions.
• Patient enrollment difficulties in clinical trials could delay completion and prevent therapeutic development.
• Actual results may differ materially from forward-looking statements due to various factors outlined in the Form 10-K.

Management Commentary and Tone:

• CEO Peter Altman stated the company believes CardiAMP is on track to be the first approved minimally invasive biologic therapy for heart failure in a first-world country based on interactions with Japan's PMDA.
• Management expressed excitement about the coming year, citing the aim to submit the Helix system for FDA approval.
• The tone reflects confidence in regulatory pathways, noting that questions remaining for PMDA submission have been addressed to satisfaction.

Other Key Points:

• The company filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2026.
• A conference call was held on November 12, 2026, at 4:30 PM ET to discuss business highlights.
• The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services.
• The company has engaged a Designated Marketing Authorization Holder (DMAH) for Japan, which may be transferred with the underlying product approval.
• The Helix system's performance for all developers is expected to be enhanced by the Heart3D fusion imaging platform.