BioCardia, Inc. (BCDA) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call shows mixed signals: a slight increase in revenue, reduced SG&A expenses, and a decrease in net loss for Q3, but an increase in net loss over nine months. The Q&A reveals positive progress in trials but lacks transparency in patient enrollment numbers. The strategic plan highlights potential partnerships and regulatory approvals, which could be positive. However, the absence of market cap data and the lack of immediate strong catalysts lead to a neutral outlook for short-term stock movement.
Key Financial Performance
Research and Development (R&D) Expenses Increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, and to $3.8 million for the 9 months ended September 2025 from $3.0 million for the same period in 2024. The increase was driven by the closeout of the CardiAMP Heart Failure study, statistical data analysis, new enrollment in the CardiAMP Heart Failure II trial, and regulatory activities for potential approvals.
Selling, General, and Administrative (SG&A) Expenses Decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and to $2.4 million for the 9 months ended September 2025 from $2.8 million for the same period in 2024. The decrease was primarily due to lower compensation expenses and lower professional service fees, coupled with reduced share-based compensation expenses.
Net Loss Decreased to $1.5 million for Q3 2025 from $1.7 million in Q3 2024. However, it increased to $6.2 million for the 9 months ended September 2025 from $5.5 million for the same period in 2024. The changes reflect variations in operational costs and financing activities.
Net Cash Used in Operations Decreased to $1.5 million in Q3 2025 from $1.7 million in Q3 2024, and to $4.9 million for the 9 months ended September 2025 from $5.5 million for the same period in 2024. The decrease was due to improved operational efficiencies.
Cash on Hand Ended Q3 2025 with $5.3 million in cash, reflecting a $6 million September financing and 304,000 shares of stock sold during the quarter under the company's ATM program. This cash is expected to provide runway into Q2 2026 without additional financing.
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Operating Highlights
CardiAMP cell therapy: Received FDA breakthrough designation and has shown promise in treating ischemic heart failure. Actively enrolling in the CardiAMP Heart Failure II clinical study. Positive preliminary consultation with Japan's PMDA, with potential market entry in Japan. CardiAMP system is already approved in Japan for orthopedic applications.
CardiALLO allogeneic mesenchymal stem cell therapy: Off-the-shelf cell therapy being advanced in a Phase I/II trial for inflammatory ischemic heart failure. Potential for conditional approval in Japan based on trial results.
Helix Biotherapeutic Delivery System: Supports therapeutic agent programs and partners. Preparing a de novo 510(k) submission for FDA approval.
Heart 3D Fusion Imaging: Partnership with CART-Tech to develop imaging solutions for biotherapeutic delivery and cardiac biopsy. Promising results in animal studies, with clinical advancement planned for 2026.
Japan market expansion: Positive consultation with Japan's PMDA for CardiAMP system. Japan's aging population and limited heart failure treatment options make it a key market.
R&D expenses: Increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, driven by CardiAMP Heart Failure study closeout and new trial enrollment.
SG&A expenses: Decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, primarily due to lower compensation expenses.
Net loss: Reduced to $1.5 million in Q3 2025 from $1.7 million in Q3 2024. Cash on hand expected to last until Q2 2026.
Funding strategy: Pursuing nondilutive funding for CardiALLO trial and pathways to fund CardiAMP Heart Failure II study to completion.
Regulatory strategy: Engaging with FDA and PMDA for approvals of CardiAMP and Helix systems. Preparing for FDA submission for Helix system in Q4 2025.
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Risk or Challenges
Regulatory Approvals: The company faces inherent uncertainties in developing new products and obtaining regulatory approvals, which could delay market entry and impact financial performance.
Clinical Trials: The CardiAMP Heart Failure II trial is still in progress, and its success is critical for the company's future. Delays or negative outcomes could adversely affect strategic objectives.
Funding Challenges: The company is pursuing pathways for nondilutive funding to complete trials, but lack of funding clarity could hinder progress.
Market Entry in Japan: While there is potential for approval in Japan, the process is still ongoing, and any delays or negative outcomes could impact the company's expansion plans.
Operational Costs: Research and development expenses have increased, and while selling, general, and administrative expenses have decreased, the company still faces financial pressures.
Cash Runway: The company has cash to operate only until the second quarter of 2026, necessitating additional financing to sustain operations.
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Guidance & Outlook
CardiAMP System Approvals: BioCardia anticipates submitting for approval of the CardiAMP system for market entry in Japan following a positive consultation with Japan's PMDA. A meeting with the FDA on the approvability of the CardiAMP system is also expected in Q4 2025.
CardiAMP Heart Failure II Trial: The confirmatory Phase 3 trial is accelerating with active enrollment at four centers and additional centers being onboarded. The trial aims to validate the efficacy of the CardiAMP system using a composite primary outcome measure.
BCDA-02 CardiAMP Therapy for Chronic Myocardial Ischemia: BioCardia plans to seek peer-reviewed publication of positive trial results in Q1 2026, which showed significant improvements in exercise tolerance and reduction in angina episodes.
BCDA-03 CardiALLO Therapy: The company expects clarity on nondilutive funding for the Phase I/II trial in Q1 2026. Positive results could enable submission for conditional approval in Japan.
Helix Biotherapeutic Delivery System: BioCardia plans to submit for FDA approval of the Helix system in Q4 2025, which could enhance regulatory support for CardiAMP programs.
Heart 3D Fusion Imaging: The company intends to advance Heart 3D fusion imaging to clinical trials in 2026, following promising results in animal studies.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:For the CardiAMP CMI data announced in September, how many patients were part of this data set, and how are these results incremental to the initial 4 patient rolling cohort data presented in April last year?
A:The CardiAMP CMI data contains 5 patients who have been enrolled at their primary endpoint out to 6 months. The results are incremental to the initial 4 patient rolling cohort data as they provide additional longer-term follow-up data. The rolling cohort is now completed and being prepared for submission for publication.
Q:Can you confirm that the rolling cohort for CardiAMP CMI consists of 5 patients total?
A:Yes, the rolling cohort consists of 5 patients total. The study benefits from extensive clinical experience in CardiAMP ischemic heart failure trials and is designed as a trial for approval with the rolling cohort.
Q:Can you provide anecdotal stories on how recruitment is going for CardiAMP Heart Failure II and any challenges faced?
A:Recruitment for CardiAMP Heart Failure II is progressing smoothly. Enrollment is easier due to the use of cell population analysis to set dosage, which allows inclusion of patients who might have been excluded previously. Challenges are primarily resource-driven, as the team is also completing a Phase 3 trial and preparing data for regulatory submissions. There are no unusual hurdles, and the trial is expected to accelerate as resources become available.
Q:How many centers are enrolling for CardiAMP Heart Failure II, and how many patients have been enrolled?
A:There are 4 centers enrolling, and 3 of them have enrolled their first patients. However, the exact current patient count is not being shared. The company will announce as each site enrolls its first patient but will not provide ongoing patient counts.
Q:Is there a partnership or funding expected to close in the first quarter of 2026 for BCDA-03?
A:Yes, there is federal grant funding expected, assuming the federal government opens up. Conversations with the NIH have been positive, and there is a high probability of funding for the program. This funding would fully support running another trial in parallel to CardiAMP HF II.
Q:What are the next steps for interactions with Japanese regulatory authorities for approval in Japan?
A:The next step is a formal clinical consultation with Japanese regulatory authorities to determine if the clinical data from CardiAMP-HF, Phase II TAC-HFT, and Phase I TABMMI is sufficient to support safety and efficacy for approval in Japan. Most of the work for these submissions is complete, and the company is currently in a waiting mode.
Q:What are the expectations for getting additional clinical sites on board for CardiAMP HF II?
A:Getting additional sites on board is primarily a bandwidth issue for the company. Some clinical research sites are asking for higher start-up costs due to reduced federal funding, but this is not expected to be a significant issue. The process involves new contracting and budgeting, which takes staff time. Enrollment is expected to take at least another year.
Q:Review of Unclear Management Responses
A:Management avoided providing a direct answer to the exact current patient count for CardiAMP Heart Failure II, stating that they will not share ongoing patient counts but will announce as each site enrolls its first patient.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Biotherapeutic Delivery
CardiAMP HF
CardiAMP Heart
CardiAMP cell
CardiAMP system
Delivery System
FDA breakthrough
HF II
HF study
Heart fusion
Helix Biotherapeutic
II study
Phase patient
agent delivery
approvability
average
cell processing
delivery device
ejection fraction
failure ejection
funding
imaging
improvement
meeting
population
procedure CardiAMP
promise
result trial
study CardiAMP
submission approval
submission strength
system CardiAMP
therapy treatment
treatment heart
treatment patient
update
BCDA Transcript
BioCardia, Inc. (BCDA) Q1 2026 Earnings Call Transcript
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The earnings call shows a mixed picture: a 25% revenue increase and improved net loss are positive, but the inherent regulatory and product development risks pose concerns. The absence of strategic initiatives and shareholder return discussions limits the positive impact. Cash reserves have decreased, but cost controls are in place. The lack of market cap data prevents assessment of stock sensitivity. Overall, the sentiments are balanced, leading to a neutral prediction for stock movement.
BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript
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The earnings call reveals mixed sentiments: increased R&D expenses and operational costs are concerning, but the CardiAMP HF's potential FDA approval and competitive advantage offer optimism. The Q&A highlights slow trial enrollment and non-significant p-values, but also potential regulatory success and partnership interest. The absence of strong financial guidance and the challenge of rising costs balance the positive aspects, leading to a neutral outlook for the stock price over the next two weeks.
BioCardia, Inc. (BCDA) Q3 2025 Earnings Call Transcript
Unknown11-13
The earnings call shows mixed signals: a slight increase in revenue, reduced SG&A expenses, and a decrease in net loss for Q3, but an increase in net loss over nine months. The Q&A reveals positive progress in trials but lacks transparency in patient enrollment numbers. The strategic plan highlights potential partnerships and regulatory approvals, which could be positive. However, the absence of market cap data and the lack of immediate strong catalysts lead to a neutral outlook for short-term stock movement.
BioCardia, Inc. (BCDA) Q2 2025 Earnings Call Transcript
Unknown8-11
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.
BCDA Report
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