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EarningsQ2 2026 Earnings Report
BCDA Q2 2026 EPS Results
Actual EPS-$0.13
Consensus EPS-$0.18
Beat/MissBeat by +$0.05
One Year Ago EPS-$0.40
BCDA Q2 2026 Revenue Results
Actual Revenue$0.00
Expected Revenue$0.00
Beat/MissMet expectations
YoY Revenue Growth―
Earnings Announcement Details
QuarterQ2 2026
Date08/12/2026
TimeAfter Close
Conference CallWednesday, August 12, 2026
BCDA Upcoming Earnings
BioCardia's next earnings date is estimated for November 11, 2026, based on past reporting schedules.
Q2 2026 Earnings Call Audio
BCDA Q2 2026 Earnings Call
0:00 / 0:00
Q2 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q2 2026 Earnings Call Summary
Earnings Call Sentiment|Positive
The call emphasized meaningful regulatory progress across Japan (PMDA) and the U.S. (FDA) and favorable feedback for the HELIX catheter, supported by substantial clinical experience (~500 Helix patients, >20x procedural experience vs peers). Financially, the company improved expense control and narrowed net losses, and raised ~$4.9M, leaving cash into 2027. Key challenges include additional PMDA documentation requests, relatively slow enrollment in the U.S. confirmatory trial that is resource-constrained, tight near-term financing needs to accelerate enrollment, and some regulatory process uncertainties (FDA minutes delay, endpoint discussions, reimbursement timing). On balance, positives (regulatory momentum, commercialization pathway in Japan, improved financial trends) materially outweigh the operational and cash runway challenges, though execution risk remains.Company Guidance
Regulatory Progress – Japan (PMDA) Supports Shonin Pathway
PMDA provided consultation advice supporting advancement to a Shonin premarket submission for CARDiAmp, calling trial outcomes credible. Company expects to address remaining questions, complete eTMF, conduct Japanese GCP audits, structure data to CDISC, sign a DMAH, and submit with an expected approval ~12 months after submission. Initial target indication ~20,000 patients in Japan (out of ~300,000 with ischemic heart failure).
Regulatory Progress – United States (FDA)
FDA Q-Sub meeting minutes indicate the ongoing CARDiAmp Heart Failure II trial may support premarket approval/market clearance as a confirmatory trial; FDA raised no safety or delivery concerns and will discuss primary outcome measures, particularly the quality-of-life tier.
HELIX Catheter – Favorable Regulatory Feedback and Strong Clinical Data
FDA de novo pre-submission identified two possible pathways for Helix and raised no safety/performance concerns. Helix has CE mark in Europe and ~500 patients across >12 clinical trials, positioning it as a differentiated delivery platform and potential partner-enabler for gene/biologic therapies.
Clinical Enrollment Continuing with No Reported Safety Issues
CARDiAmp Heart Failure II is actively enrolling: 4 clinical sites active, 3 additional patients expected to qualify this month, and 2 procedures scheduled this month; management reported no safety issues.
Fundraising and Cash Position
Raised approximately $4.9 million net proceeds from ATM issuance at an average price of $1.22 per share. Ended quarter with $5.4 million cash and cash equivalents, providing runway into 2027 and current NASDAQ compliance noted.
Improved Expense and Loss Trends
Total expense decreased to $1.6M in Q2 2026 from $2.1M in Q2 2025 (down ~$400K, ~19%). Six-month expense decreased to $3.9M from $4.8M (~$900K, ~19%). R&D expense decreased Q/Q to $0.9M from $1.4M (down $0.5M, ~36%). Net loss narrowed to $1.6M in Q2 2026 vs $2.0M in Q2 2025 (improvement of ~20%); six-month net loss improved ~20% to $3.9M from $4.9M.
Market & Commercial Opportunity Signals
Precedent: another cardiac cell therapy in Japan received reimbursement (~$326,000 per treatment), suggesting meaningful pricing potential. Company notes ~250,000 cardiac catheterization interventions per year in Japan and that Biocardia has performed >20x as many clinical procedures as two publicly traded Japanese peers combined.
Active Business Development
Ongoing discussions in Asia-Pacific for cardiovascular therapeutics and biotherapeutic delivery partnerships; potential deals could include funding to advance additional indications (chronic myocardial ischemia) and allogeneic programs (CardiALLO).
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