BioCardia Inc (BCDA)
NASDAQ:BCDA
Earnings Data
Report Date
May 13, 2026After Close (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.17Last Year’s EPS
-0.59Same Quarter Last Year
Moderate Buy
Based on 2 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Neutral
The call conveyed meaningful clinical progress and several important near‑term regulatory and scientific catalysts—most notably statistically significant benefits in a predefined high‑risk subgroup, initiation of a confirmatory trial, and active regulatory engagements. However, there are material risks: primary endpoints in the full cohort narrowly missed statistical significance; cash on hand (~$2.5M) is limited relative to annual operating cash use (~$7.5M); enrollment is early and resource constrained; and regulatory pathway and potential post‑marketing commitments remain uncertain. Overall, positives around clinical data and multiple catalysts are tempered by financial runway and execution risks, making the tone balanced.Company Guidance
Consistent Positive Clinical Signal Across Three Trials
BioCardia reported complete and final data from 3 clinical trials of CardiAMP showing reduced major adverse cardiac and cerebrovascular events (MACE) and improved heart function across studies, with two trials randomized and double-blinded—providing strong scientific rigor and consistent directional benefit.
Statistically Significant Benefits in Prespecified High-Risk Subgroup
In the prespecified subgroup of patients with elevated NT-proBNP (markers of heart stress), echocardiographic reductions in left ventricular volumes were clinically meaningful (>20 mL/m^2 and >15 mL/m^2) and statistically significant (p=0.02 and p=0.01), supporting the therapy’s effect on suppressing pathological ventricular remodeling.
Near-Term Regulatory and Scientific Catalysts
Management outlined four near-term catalysts: (1) drafted FDA Q-submission for CardiAMP under Breakthrough designation (under legal review), (2) formal clinical consultation with Japan PMDA on approvability, (3) FDA substantive feedback meeting for Helix transendocardial delivery system via de novo pathway, and (4) an accepted EuroPCR oral presentation on CardiAMP in May—creating multiple paths to regulatory clarity or visibility.
Confirmatory Trial Initiated and Active Site Expansion
CardiAMP HF II confirmatory study has been initiated with four centers actively enrolling (University of Wisconsin–Madison, Henry Ford Health System, Emory University activated; Morton Plant Mease included), focusing on the subgroup most likely to respond and applying learnings on endpoints and trial design.
Helix Delivery System Progress
The dedicated Helix transendocardial delivery catheter has a pre-submission actively under review by FDA Center for Devices and Radiological Health (CDRH), advancing the device component used to deliver both CardiAMP and CardiALLO therapies.
Clear Market Opportunity
Management quantified target populations of roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure reduced ejection fraction, highlighting a large addressable market if approvals are achieved.
Disciplined Operating Cost Trends
Management demonstrated cost control: total expense increased modestly by ~3% to $8.3 million in 2025; selling, general & administrative (SG&A) expenses decreased ~10% to $3.3 million (from $3.7M), driven by lower professional fees and reduced share-based compensation, and net cash used in operations improved slightly to ~$7.5M from $7.9M.
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 |
|---|---|---|---|
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% |
May 14, 2025 | $2.77 | $2.32 | -16.25% |
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 May 13, 2026, After Close (Confirmed).
What is BioCardia Inc (BCDA) earnings time?
BioCardia Inc (BCDA) earnings time is at May 13, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
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 (Q1) is -0.17.