BioCardia, Inc. (BCDA) Q2 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call reveals mixed signals. Financial performance shows increased net loss and cash usage, which are negative. However, there are ongoing advancements in trials and partnerships, which are positive. The Q&A highlights uncertainties around regulatory approvals and partnerships, but also potential growth opportunities. The neutral sentiment reflects this balance of positive developments against financial challenges and uncertainties.

Key Financial Performance

Research and Development Expenses (Q2 2025) Increased to approximately $1.4 million from approximately $0.8 million in Q2 2024, a 75% increase. The increase was driven by closeout activities including data analysis for the CardiAMP Heart Failure trial, enrollment in the CardiAMP Heart Failure II trial, and regulatory activities in Japan.

Research and Development Expenses (6 months ended June 2025) Increased to approximately $2.9 million from $2.0 million in the 6 months ended June 2024, a 45% increase. The reasons for the increase are similar to those for Q2 2025.

Selling, General and Administrative Expenses (Q2 2025) Decreased to approximately $0.7 million from approximately $0.9 million in Q2 2024, a 22% decrease. This was primarily due to lower professional fees and share-based compensation expense.

Selling, General and Administrative Expenses (6 months ended June 2025) Remained consistent at approximately $1.9 million compared to the same period in 2024. No significant changes were noted.

Net Loss (Q2 2025) Increased to approximately $2.0 million from approximately $1.6 million in Q2 2024, a 25% increase. The increase was attributed to higher research and development expenses.

Net Loss (6 months ended June 2025) Increased to approximately $4.8 million from approximately $3.9 million in the 6 months ended June 2024, a 23% increase. The increase was attributed to higher research and development expenses.

Net Cash Used in Operations (Q2 2025) Increased to approximately $1.6 million from approximately $1.3 million in Q2 2024, a 23% increase. This was driven by the increase in research and development expenses.

Net Cash Used in Operations (6 months ended June 2025) Increased to approximately $3.3 million from approximately $2.8 million in the 6 months ended June 2024, a 17.9% increase. This was driven by the increase in research and development expenses.

Cash and Cash Equivalents (End of Q2 2025) Totaled $980,000. After selling $769,000 in common stock in Q3 2025, the cash balance increased to approximately $1.1 million, providing runway into October 2025.

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Operating Highlights

CardiAMP Heart Failure trial: Completed trial with significant findings, including lower incidence of all-cause death and nonfatal MACE in treatment group. Data submitted to Japan's PMDA for potential approval.

Helix biotherapeutic delivery system: Preparing for FDA submission for approval via de novo 510(k) pathway. Potential to be the first approved transendocardial biotherapeutic delivery system in the U.S.

Morph DNA steerable introducer platform: Proprietary FDA-approved platform being positioned for partnerships in the cardiac electrophysiology market.

Japan market: Engaging with Japan's PMDA for approval of CardiAMP system. Japan has a strong interest in heart failure therapies.

Cardiac electrophysiology market: Exploring partnerships for Morph DNA platform in a market valued at over $10 billion annually.

R&D expenses: Increased to $1.4 million in Q2 2025 due to trial closeout activities and regulatory efforts in Japan.

SG&A expenses: Decreased to $0.7 million in Q2 2025 due to lower professional fees and share-based compensation.

Partnerships: Actively pursuing partnerships for CardiAMP, CardiALLO, Helix, and Morph DNA platforms to enhance shareholder value.

Financing: Planning a financing round in September 2025 to support operations and shareholder interests.

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Risk or Challenges

Regulatory Approvals: The company faces uncertainties in obtaining regulatory approvals for its CardiAMP Heart Failure therapy in both Japan and the United States. Delays or misalignment with regulatory agencies like Japan's PMDA or the FDA could impact market entry timelines and revenue generation.

Financial Stability: The company reported a net loss of $2.0 million for Q2 2025 and has limited cash reserves of $1.1 million, providing runway only into October 2025. This financial strain could hinder ongoing operations and R&D activities if additional funding is not secured.

R&D Expenses: Research and development expenses have increased significantly, driven by trial closeout activities and regulatory efforts. This rise in costs could strain financial resources further, especially given the company's limited cash reserves.

Market Competition: The company anticipates two other cardiac cell therapies to be considered for approval by Japan's PMDA in the coming year. This competitive landscape could limit market share and partnership opportunities for BioCardia's CardiAMP therapy.

Partnership Dependencies: The company is heavily reliant on partnerships for its Helix biotherapeutic delivery system and other platforms. Delays or failures in securing these partnerships could impact commercialization and revenue streams.

Operational Costs: Increased operational costs, including R&D and regulatory activities, are contributing to higher cash burn rates. This could pose a risk to the company's financial health if not managed effectively.

Funding Risks: The company is planning a financing round in September 2025, but its success is uncertain. Failure to secure adequate funding could jeopardize ongoing projects and strategic objectives.

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Guidance & Outlook

CardiAMP Heart Failure Therapy: BioCardia plans to align with Japan's PMDA in Q4 2025 for potential approval of the CardiAMP system for market entry in Japan. Concurrently, they aim to meet with the FDA in Q4 2025 to discuss the approvability of the CardiAMP system based on clinical data. The CardiAMP Heart Failure II trial is actively enrolling patients, with a fifth site activation expected soon.

CardiAMP Cell Therapy for Chronic Myocardial Ischemia (BCDA-02): Final top-line data from the roll-in cohort is expected in Q4 2025, with plans for peer-reviewed publication of the results.

CardiALLO Allogeneic Mesenchymal Stem Cell Therapy (BCDA-03): Non-dilutive funding is anticipated in Q1 2026 to support this program.

Helix Biotherapeutic Delivery System: FDA submission for approval is anticipated in Q3 2025. The system has potential to be the first approved transendocardial biotherapeutic delivery system in the U.S. BioCardia is actively seeking partnerships for this technology.

Morph DNA Steerable Introducer Platform: Partnership discussions are ongoing for applications in the cardiac electrophysiology market, which exceeds $10 billion annually.

Business Development and Partnerships: BioCardia is focused on partnerships across its platforms (CardiAMP, CardiALLO, Helix, and Morph DNA) to enhance shareholder value. They are actively engaging with potential partners for biotherapeutic delivery and cardiac electrophysiology applications.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Could you elaborate on the expectations regarding PMDA reviewing CardiAMP for heart failure as a medical device?

A:The approval process for CardiAMP in Japan is considered a lower hurdle compared to other medical devices since it leaves nothing behind in the patient. The PMDA consultation process involves clinical data and therapy positioning in heart failure care. CardiAMP aligns with Japanese cultural preferences for autologous therapies and fits into existing medical device distribution channels. Japan has a significant need for heart failure therapies due to low heart transplantation rates and high mortality rates. PMDA may request post-marketing studies to gather additional safety and efficacy data.

Q:Are the rolling core data anticipated in the fourth quarter related to the primary endpoint results at 6 months?

A:Yes, the rolling core data anticipated in the fourth quarter are related to the primary endpoint results at 6 months.

Q:What would the timing look like if the regulatory meetings in Japan and the U.S. go well?

A:If the PMDA and FDA meetings go well, the approval process could take up to a year, including audits and detailed reviews. In Japan, the focus would shift to reimbursement and distribution partnerships. For the FDA, the Helix system will be submitted first, followed by CardiAMP Heart Failure. Post-marketing requirements are expected in both regions.

Q:Are partnerships on hold until clarity on FDA and PMDA approvals?

A:No, partnerships are not on hold. While CardiAMP partnerships depend on regulatory clarity, active discussions are ongoing for other technology platforms like Helix and Morph. Distribution partnerships in Japan are also being explored.

Q:What type of meeting will the FDA meeting be, and what is the status of the HF II trials?

A:The type of FDA meeting (Type B or Type C) has not been decided. CardiAMP HF II trials have 4 active centers, with a fifth starting soon. Patients are being observed for a month before baseline measures to account for the Hawthorne effect. The trial focuses on patients with elevated NT-proBNP and has Medicare reimbursement in place.

Q:Will clarity from PMDA and FDA be available by the end of Q4?

A:Clarity from PMDA is expected by the end of Q4, but FDA clarity will follow later as the Helix system submission precedes CardiAMP discussions.

Q:What are the expectations following the data readout for BCDA-02?

A:The BCDA-02 program is positioned for partnering discussions. If PMDA or FDA approvals for CardiAMP are favorable, resources could be allocated to accelerate BCDA-02. The program offers a low-cost therapy compared to competitors and has shown promising results.

Q:Will new data observations submitted to PMDA be released to the public?

A:Some new data observations will be included in a peer-reviewed manuscript for public access, but certain details may remain exclusive to regulatory submissions.

Q:How will the September financing event benefit shareholders?

A:The company aims to secure financing with minimal dilution, focusing on long-term holders. The burn rate is low, and the company is prioritizing non-dilutive capital to fund its programs.

Q:Review of Unclear Management Responses

A:Management avoided providing a direct answer on the type of FDA meeting (Type B or Type C) for CardiAMP discussions, stating that the decision is still under consideration. Additionally, while they mentioned active partnering discussions, specific details or timelines for these partnerships were not provided.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

BCDA Transcript

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Earnings call transcript: BioCardia’s Q1 2025 results show clinical progress

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The earnings call reveals financial challenges, including a significant net loss, increased expenses, and a low cash position. While there are potential partnerships and regulatory progress, the failure to meet primary endpoints in trials and competitive market pressures raise concerns. The Q&A session shows management's vague responses on key issues, adding to uncertainty. Despite some positive aspects, such as modest financing and ongoing trials, the overall sentiment is negative due to financial instability and regulatory risks.

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The earnings call summary suggests a negative outlook due to several factors: increasing net losses, low cash reserves, and high financial risks. The Q&A section shows management's vague responses and lack of clarity on strategic timelines, which may raise investor concerns. Despite ongoing partnerships and potential regulatory approvals, the financial health and competitive pressures overshadow these positives. The market's reaction is likely negative due to financial instability and uncertainties in achieving key milestones.

BCDA Report

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