BioCardia Inc (BCDA)
NASDAQ:BCDA
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BioCardia
(NASDAQ:BCDA)
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Rating:45Neutral
Price Target:
$0.99
▼(-16.53% Downside)
Action:Reiterated
Date:05/18/26
The score is held down primarily by very weak financial performance (no meaningful revenue, large losses, heavy cash burn and negative equity) and bearish technicals (price below key moving averages with negative MACD). Positive regulatory/clinical updates from the earnings call provide some support, but they are outweighed by immediate financing needs and execution risk to reach key trial and approval milestones.
Positive Factors
Regulatory momentum in Japan (PMDA receptivity)
PMDA willingness to accept foreign CardiAMP data materially shortens the path to Japanese market entry versus requiring a full new pivotal trial. That reduces development time/cost, enables earlier reimbursement discussions and revenue opportunity in a defined ~20,000 patient initial market, and de-risks international commercialization timing.
Negative Factors
Very weak financial position and negative equity
Zero meaningful revenue, sustained operating losses and negative equity materially constrain strategic flexibility. The balance sheet weakness increases dependence on external funding, raises dilution and financing risk, and limits capacity to scale trials, commercial launch activities, or weather regulatory delays over the coming 2-6 months.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory momentum in Japan (PMDA receptivity)
PMDA willingness to accept foreign CardiAMP data materially shortens the path to Japanese market entry versus requiring a full new pivotal trial. That reduces development time/cost, enables earlier reimbursement discussions and revenue opportunity in a defined ~20,000 patient initial market, and de-risks international commercialization timing.
Read all positive factors
BioCardia (BCDA) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$10.24M
Dividend YieldN/A
Average Volume (3M)1.15M
Price to Earnings (P/E)―
Beta (1Y)1.53
Revenue Growth-100.00%
EPS Growth59.83%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.03
Shares Outstanding11,374,724
10 Day Avg. Volume282,453
30 Day Avg. Volume1,147,607
Financial Highlights & Ratios
PEG Ratio0.02
Price to Book (P/B)9.31
Price to Sales (P/S)0.00
P/FCF Ratio-1.12
Enterprise Value/Market Cap0.49
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-2.79
Enterprise Value/Ebitda-0.67
Forecast
1Y Price Target
$15.50Price Target Upside1213.56% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)-0.63
Revenue Forecast (FY)N/A
BioCardia Business Overview & Revenue Model
Company Description
BioCardia, Inc., a clinical-stage regenerative medicine company, develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. Its lead therapeutic candidate is the CardiAMP Cell Therapy System for the treatment of hea...
How the Company Makes Money
BioCardia’s revenue model has historically been primarily supported by financing activities rather than recurring commercial product sales; detailed, consistent product-level revenue by stream is not publicly available in a way that can be stated ...
BioCardia Earnings Call Summary
Earnings Call Date:May 15, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 12, 2026
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.Positive Updates
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.
Negative Updates
Limited Cash Balance and Near-Term Funding Requirement
The company ended the quarter with $951,000 in cash and cash equivalents. With net cash used in operations of $1.7M for the quarter (a 6.3% increase vs $1.6M in Q1 2025), the current cash balance represents less than one quarter of operating cash use at the present burn rate, creating a material near-term funding need.
Read all updates
Q1-2026 Updates
Positive
Negative
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.
Read all positive updates
Company Guidance
Management's guidance focused on two near-term priorities: preparing and submitting a Shonin PMDA application for Japan (≈7 months to prepare, followed by an ≈1‑year review — ~19 months to approval if on plan) and enrolling the CardiAMP Heart Failure II trial (250‑patient trial, 160 patients required for 80% power; 4 centers activated with more being onboarded); the company expects to complete one or more transactions in Q2 2026 to fund the Japan PMDA submission and HF II enrollment. Key financial and operational metrics: Q1 2026 total expense $2.3M (down $460k YoY), R&D $1.2M (down $295k YoY), SG&A $1.0M (vs $1.2M prior year), net loss $2.3M (vs $2.7M), net cash used in operations $1.7M (vs $1.6M), and cash & cash equivalents $951k at March 31, 2026. Regulatory notes: FDA signaled a premarket approval (PMA) pathway and encouraged completion of HF II, Helix has two potential clearance routes (simultaneous with CardiAMP or de novo standalone), and Japan indicated willingness to accept the existing CardiAMP data with a post‑marketing study (with reimbursement). Reimbursement and market metrics: Medicare reimbursement today $20,000 per procedure, Japan initial reachable market ~20,000 patients (out of ~300,000 ischemic HF patients), implying a potential ~$400M market using current U.S. reimbursement math; additional data will be presented at EuroPCR next week.BioCardia Financial Statement Overview
Summary
Income Statement
8
Very Negative
Balance Sheet
18
Very Negative
Cash Flow
10
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 58.00K | 477.00K | 1.35M | 1.01M |
| Gross Profit | -1.78M | -505.00K | -4.33M | -7.25M | -7.48M | 375.00K |
| EBITDA | -7.39M | -7.77M | -7.93M | -11.56M | -11.82M | -12.57M |
| Net Income | -7.78M | -8.23M | -7.95M | -11.57M | -11.91M | -12.62M |
Balance Sheet | ||||||
| Total Assets | 1.71M | 3.41M | 3.72M | 2.99M | 9.79M | 15.72M |
| Cash, Cash Equivalents and Short-Term Investments | 951.00K | 2.50M | 2.37M | 1.10M | 7.36M | 12.87M |
| Total Debt | 412.00K | 528.00K | 951.00K | 1.31M | 1.63M | 1.87M |
| Total Liabilities | 2.78M | 2.52M | 2.89M | 4.59M | 4.90M | 5.34M |
| Stockholders Equity | -1.07M | 895.00K | 837.00K | -1.60M | 4.89M | 10.38M |
Cash Flow | ||||||
| Free Cash Flow | -7.49M | -7.44M | -8.03M | -9.99M | -10.63M | -10.48M |
| Operating Cash Flow | -7.48M | -7.44M | -8.03M | -9.97M | -10.56M | -10.37M |
| Investing Cash Flow | -10.00K | -7.00K | -6.00K | -12.00K | -70.00K | -116.00K |
| Financing Cash Flow | 7.49M | 7.57M | 9.30M | 3.73M | 5.12M | 1.95M |
BioCardia Technical Analysis
Negative
1.18
Price Trends
1.16
Negative
1.21
Negative
1.38
Negative
Market Momentum
-0.05
Positive
32.59
Neutral
17.71
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BCDA, the sentiment is Negative. The current price of 1.18 is above the 20-day moving average (MA) of 1.10, above the 50-day MA of 1.16, and below the 200-day MA of 1.38, indicating a bearish trend. The MACD of -0.05 indicates Positive momentum. The RSI at 32.59 is Neutral, neither overbought nor oversold. The STOCH value of 17.71 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for BCDA.
BioCardia Risk Analysis
BioCardia disclosed 69 risk factors in its most recent earnings report. BioCardia reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
BioCardia Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
45 Neutral | $10.24M | -1.45 | -317.47% | ― | -100.00% | 59.83% | |
43 Neutral | $8.38M | -0.26 | -97.58% | ― | 78.64% | 50.70% | |
41 Neutral | $4.75M | ― | -423.84% | ― | -8.47% | 25.61% | |
40 Underperform | $1.15M | -1.72 | 1211.14% | ― | -74.05% | 73.08% |
* Healthcare Sector Average
BCDA
BioCardia
0.95
-0.93
-49.47%
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0.18
-1.37
-88.19%
LYRA
Lyra Therapeutics
0.74
-3.96
-84.30%
BOLT
Bolt Biotherapeutics
4.72
-1.62
-25.55%
BioCardia Corporate Events
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Secures FDA Pathways for Helix Catheter System
Positive
May 8, 2026
On May 8, 2026, BioCardia reported that a Pre-Submission Meeting with the FDA produced agreement on two potential marketing clearance pathways for its Helix Transendocardial Delivery Catheter System. The agency raised no concerns about Helix’...
Business Operations and StrategyRegulatory Filings and Compliance
BioCardia Gains Japanese Patent for Heart3D Imaging Technology
Positive
Apr 28, 2026
On April 28, 2026, BioCardia announced that Japanese authorities had allowed a patent titled “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation” covering its proprietary Heart3D fusion imaging software. Th...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Gains Key Japanese Regulatory Support for CardiAMP
Positive
Apr 20, 2026
BioCardia, Inc., a Sunnyvale, California-based developer of cellular and cell-derived therapies for cardiovascular and pulmonary disease, is advancing a portfolio led by its CardiAMP autologous and CardiALLO allogeneic cell therapies. These minima...
Business Operations and StrategyRegulatory Filings and Compliance
BioCardia Seeks Accelerated FDA Pathway for CardiAMP HF
Positive
Apr 2, 2026
On April 2, 2026, BioCardia reported that it had submitted CardiAMP HF clinical study data to the U.S. Food and Drug Administration and requested a meeting this quarter under its Breakthrough Designation to discuss an accelerated approval pathway ...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances Helix Catheter Toward FDA Marketing Clearance
Positive
Mar 17, 2026
On March 17, 2026, BioCardia announced that the U.S. Food and Drug Administration accepted its pre-submission package seeking marketing approval for the Helix Transendocardial Delivery Catheter, a minimally invasive system for intramyocardial deli...
Business Operations and Strategy
BioCardia Highlights Positive CardiAMP Phase III Heart Failure Data
Positive
Mar 3, 2026
On March 3, 2026, BioCardia reported late-breaking echocardiography data from its Phase III CardiAMP HF trial in ischemic heart failure with reduced ejection fraction, presented at the Technology and Heart Failure Therapeutics conference. The auto...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.