BioCardia Inc (BCDA)
NASDAQ:BCDA
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BioCardia
(NASDAQ:BCDA)
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Rating:45Neutral
Price Target:
$1.00
▼(-15.25% Downside)
Action:Reiterated
Date:06/09/26
The score is held down primarily by very weak financial performance (no meaningful revenue, sustained losses, and heavy cash burn with negative equity). Offsetting this, the latest earnings call reflects credible regulatory/clinical progress and cost control, but execution and financing needs remain material. Technically, the stock remains in a broader downtrend, and valuation is not supportive given negative earnings and no dividend.
Positive Factors
Regulatory momentum: defined FDA & PMDA pathways
Clear regulatory pathways from both FDA (PMA via CardiAMP HF II) and PMDA (acceptance of existing trial data for Shonin) materially reduce regulatory uncertainty. This structural clarity supports strategic planning, partner discussions, and targeted fundraising tied to defined milestone timing.
Negative Factors
Acute cash shortage vs. burn
With under one quarter of runway at the current burn rate, the company faces a structural liquidity constraint that forces near-term financings or cutbacks. This reduces control over timing of trials and submissions, increases dilution risk, and can hamper steady execution of regulatory milestones.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory momentum: defined FDA & PMDA pathways
Clear regulatory pathways from both FDA (PMA via CardiAMP HF II) and PMDA (acceptance of existing trial data for Shonin) materially reduce regulatory uncertainty. This structural clarity supports strategic planning, partner discussions, and targeted fundraising tied to defined milestone timing.
Read all positive factors
BioCardia (BCDA) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$11.83M
Dividend YieldN/A
Average Volume (3M)1.15M
Price to Earnings (P/E)―
Beta (1Y)1.45
Revenue Growth-100.00%
EPS Growth59.83%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.03
Shares Outstanding14,884,328
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 Cap0.41
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-2.72
Enterprise Value/Ebitda-0.66
Forecast
1Y Price Target
$15.50Price Target Upside1213.56% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)-0.66
Revenue Forecast (FY)N/A
BioCardia Business Overview & Revenue Model
Company Description
BioCardia, Inc. is a pioneering clinical-stage company dedicated to regenerative medicine, focusing on the development of advanced cellular and cell-derived therapies for a range of cardiac and respiratory ailments. Central to its pipeline is the ...
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 | -7.35M | -7.72M | -7.88M | -11.49M | -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
1.06
Negative
1.14
Negative
1.30
Negative
Market Momentum
-0.06
Positive
34.84
Neutral
1.78
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 0.92, above the 50-day MA of 1.06, and below the 200-day MA of 1.30, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 34.84 is Neutral, neither overbought nor oversold. The STOCH value of 1.78 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 | $11.83M | -1.11 | -317.47% | ― | -100.00% | 59.83% | |
45 Neutral | $9.68M | ― | -423.84% | ― | -8.47% | 25.61% | |
40 Underperform | $1.07M | -0.24 | 1211.14% | ― | -74.05% | 73.08% | |
40 Underperform | $9.17M | -0.30 | -97.58% | ― | 78.64% | 50.70% |
* Healthcare Sector Average
BCDA
BioCardia
0.80
-1.41
-63.86%
BRTX
BioRestorative Therapies
0.38
-1.62
-81.20%
LYRA
Lyra Therapeutics
0.60
-11.25
-94.94%
BOLT
Bolt Biotherapeutics
4.77
-1.46
-23.43%
BioCardia Corporate Events
Business Operations and StrategyPrivate Placements and Financing
BioCardia Raises $4.4 Million to Extend Cash Runway
Positive
Jun 8, 2026
On June 8, 2026, BioCardia announced it had raised approximately $4.4 million by selling 3,509,604 shares at an average price of $1.279 on June 5, 2026, under its at-the-market offering agreement with H.C. Wainwright Co. The capital raise was com...
Business Operations and StrategyRegulatory Filings and Compliance
BioCardia Gains FDA Path for CardiAMP PMA Approval
Positive
Jun 5, 2026
On June 5, 2026, BioCardia announced that minutes from its Q-Sub meeting with the FDA’s Center for Biologics Evaluation and Research confirmed the ongoing CardiAMP Heart Failure II Trial may be used to support a Premarket Approval applicatio...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia gains PMDA support for CardiAMP heart therapy
Positive
May 28, 2026
On May 28, 2026, BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency issued a Consultation Record supporting a regulatory submission for the company’s CardiAMP cell therapy to treat ischemic heart failure with redu...
Business Operations and StrategyProduct-Related Announcements
BioCardia Announces Encouraging CardiAMP Chronic Ischemia Data
Positive
May 21, 2026
On May 21, 2026, BioCardia reported preliminary open-label cohort results from its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial, presented at the EuroPCR conference in Paris by Dr. Amish Raval. The minimally invasive autologous cell ...
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...
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.