BioCardia Inc (BCDA)
NASDAQ:BCDA
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Earnings Data
Report Date
Aug 12, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.18Last Year’s EPS
-0.4Same Quarter Last Year
Moderate Buy
Based on 2 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Neutral
The call conveyed strong clinical and regulatory progress—statistically significant blinded echocardiography results, constructive PMDA guidance in Japan, favorable FDA engagement, device pathway clarity for Helix, and reduced operating expenses. However, these positives are tempered by an immediate funding shortfall (cash of $951k), the need to complete an additional pivotal trial for U.S. approval (PMA pathway) and enrollment/resource risks for the HF II study. Management plans near-term financing in Q2 to fund the Japan submission and trial enrollment, but execution and funding risk remain material.Company Guidance
Compelling Blinded Echocardiography Data with Statistically Significant Outcomes
Blinded contrast-enhanced echocardiography analyzed by Yale's Echo Core Lab showed treated patients avoided adverse cardiac remodeling while control patients experienced increased heart volumes. In a subgroup with elevated biomarkers of heart stress, improvements in both relaxation and contraction were statistically significant and aligned with a 3-tier composite endpoint (survival without LVAD/transplant, fewer major adverse events, better quality of life) that also achieved statistical significance.
Positive Regulatory Momentum in Japan (PMDA)
Following a formal clinical consultation, Japan's PMDA indicated it is inclined to accept the CardiAMP Heart Failure trial data as the basis for a Shonin (premarket) application and provided a draft written advisory record in alignment with the meeting. BioCardia plans to prepare and submit the Shonin application in ~7 months, with an expected review period of roughly one year thereafter and a post-marketing study tied to reimbursement during early launch.
Constructive FDA Interactions and Defined Approval Pathway
FDA Center for Biologics Evaluation and Research (CBER) confirmed a premarket approval (PMA) is the appropriate U.S. pathway, raised no safety concerns for CardiAMP, found the efficacy data 'intriguing,' and encouraged completion of the ongoing CardiAMP HF II trial. FDA agreed to engage on statistical analysis nuances of the composite endpoint and provided meaningful advice to the company.
Helix Delivery System Regulatory Progress
FDA pre-submission for the Helix Transendocardial Delivery System identified two potential pathways for clearance, raised no safety or device compatibility concerns, and indicated potential for de novo approval as a standalone device or simultaneous clearance with CardiAMP approval.
Clinical Development Continuity and Scientific Visibility
CardiAMP Heart Failure II trial remains active with 4 centers enrolled and additional centers onboarding; the trial is designed for 250 patients (160 required for 80% power). Separately, CardiAMP chronic myocardial ischemia results were accepted for oral presentation at the EuroPCR meeting, increasing scientific exposure.
Reduced Operating Expenses and Improved Loss Metrics
Total expenses decreased from $2.7M to $2.3M (down $460,000, -17.0% year-over-year). Research & development expense decreased $295,000 (from $1.5M to $1.2M, -19.7%), and selling, general & administrative expense decreased $200,000 (from $1.2M to $1.0M, -16.7%). Net loss improved to $2.3M from $2.7M (improvement of $400,000, -14.8%).
BCDA Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
BCDA Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 15, 2026 | $1.09 | $1.01 | -7.34% |
Mar 24, 2026 | $1.21 | $1.20 | -0.41% |
Nov 12, 2025 | $1.30 | $1.26 | -3.08% |
Aug 11, 2025 | $1.79 | $1.68 | -6.15% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does BioCardia Inc (BCDA) report earnings?
BioCardia Inc (BCDA) is schdueled to report earning on Aug 12, 2026, After Close (Confirmed).
What is BioCardia Inc (BCDA) earnings time?
BioCardia Inc (BCDA) earnings time is at Aug 12, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
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What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is BCDA EPS forecast?
BCDA EPS forecast for the fiscal quarter 2026 (Q2) is -0.18.