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BioCardia
(NASDAQ:BCDA)
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Rating:46Neutral
Price Target:
$1.00
▼(-15.97% Downside)
Action:Reiterated
Date:10/19/26
BCDA scores low primarily due to very weak financial performance (zero revenue, ongoing losses, and sustained cash burn), reinforced by bearish technicals (price below key moving averages with negative MACD). The main support for the score is constructive regulatory and program momentum discussed on the earnings call (Japan Shonin preparation, FDA feedback for HF II and Helix), but execution and financing needs remain significant.
Positive Factors
Helix regulatory progress
FDA acceptance of the revised Helix submission advances a potentially important proprietary delivery platform toward marketing clearance. Clearance could support recurring catheter-related revenue and expand partnerships with developers of cell, gene, and protein therapies requiring targeted cardiac delivery.
Negative Factors
No meaningful revenue and continuing losses
The absence of meaningful revenue leaves BioCardia dependent on financing, licensing, or eventual regulatory success rather than established commercial cash flows. Persistent operating and net losses indicate that the business has not yet demonstrated a self-sustaining economic model over the next several quarters.
Read all positive and negative factors
Positive Factors
Negative Factors
Helix regulatory progress
FDA acceptance of the revised Helix submission advances a potentially important proprietary delivery platform toward marketing clearance. Clearance could support recurring catheter-related revenue and expand partnerships with developers of cell, gene, and protein therapies requiring targeted cardiac delivery.
Read all positive factors
BioCardia (BCDA) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$13.94M
Dividend YieldN/A
Average Volume (3M)302.35K
Price to Earnings (P/E)―
Beta (1Y)0.92
Revenue GrowthN/A
EPS Growth63.72%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.76
Shares Outstanding15,138,782
10 Day Avg. Volume157,813
30 Day Avg. Volume302,346
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 Cap0.80
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-20.69
Enterprise Value/Ebitda-1.55
Forecast
1Y Price Target
$25.00Price Target Upside2000.84% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering1
EPS Forecast (FY)-0.68
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 driven primarily by (1) sales and licensing/partnering of its catheter-based delivery technologies and related consumables, and (2) collaboration/other arrangements associated with the use of its del...
BioCardia Earnings Call Summary
Earnings Call Date:Aug 12, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 11, 2026
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.Positive Updates
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).
Negative Updates
PMDA Requested Additional Data and Documentation
PMDA requested demonstration that enrolled patients were on guideline-directed medical therapy and not eligible for revascularization, plus detailed narratives for deaths/transplants/LVADs and post-marketing study design elements. Management is chasing missing documentation for a small number (~8–9) of patients and expects this work to be straightforward but incremental.
Read all updates
Q2-2026 Updates
Positive
Negative
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).
Read all positive updates
Company Guidance
Management guided that BioCardia is preparing a Shonin submission in Japan for CARDiAmp with an expected initial addressable population of ~20,000 patients (in a country with ~300,000 ischemic HF patients and ~250,000 catheterization procedures/year) and anticipates approval about 12 months after submission, noting PMDA requests (verification of guideline‑directed medical therapy, non‑eligibility for revascularization, and detailed adjudication of all‑cause death/heart transplant/LVAD events) are addressable; FDA Q‑Subs affirmed the ongoing CARDiAmp HF II trial may serve as a confirmatory trial (no safety/delivery questions) while Helix—CE‑marked with ~500 patients across >12 trials—has two FDA pathways (preferred simultaneous approval with CARDiAmp or de novo) with formal minutes pending. Financially, the company ended Q2 with $5.4M cash (runway into 2027), raised ~$4.9M via its ATM at an average $1.22/share, used ~$1.7M in operating cash in Q2 ($3.4M for six months), reported Q2 expense of $1.6M (down $400k YoY), R&D $0.9M (down $500k YoY), SG&A $0.7M, and a Q2 net loss of $1.6M ($3.9M for six months); operationally HF II has 4 sites actively enrolling (3 additional patients expected this month, 2 procedures scheduled), BioCardia expects to complete CDISC/GCP work for Shonin, noted peer market caps of ~$250M each while claiming >20x more clinical procedures than those peers combined, and said modest financing would accelerate HF II while a proposed SEC rule change could aid capital access in Q1 2027.BioCardia Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
38
Negative
Cash Flow
14
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 | -540.00K | -505.00K | -4.33M | -7.25M | -7.48M | 375.00K |
| EBITDA | -7.21M | -7.72M | -7.88M | -11.49M | -11.82M | -12.57M |
| Net Income | -7.34M | -8.23M | -7.95M | -11.57M | -11.91M | -12.62M |
Balance Sheet | ||||||
| Total Assets | 4.75M | 3.41M | 3.72M | 2.99M | 9.79M | 15.72M |
| Cash, Cash Equivalents and Short-Term Investments | 4.12M | 2.50M | 2.37M | 1.10M | 7.36M | 12.87M |
| Total Debt | 293.00K | 528.00K | 951.00K | 1.31M | 1.63M | 1.87M |
| Total Liabilities | 2.06M | 2.52M | 2.89M | 4.59M | 4.90M | 5.34M |
| Stockholders Equity | 2.70M | 895.00K | 837.00K | -1.60M | 4.89M | 10.38M |
Cash Flow | ||||||
| Free Cash Flow | -7.57M | -7.44M | -8.03M | -9.99M | -10.63M | -10.48M |
| Operating Cash Flow | -7.56M | -7.44M | -8.03M | -9.97M | -10.56M | -10.37M |
| Investing Cash Flow | -9.00K | -7.00K | -6.00K | -12.00K | -70.00K | -116.00K |
| Financing Cash Flow | 10.71M | 7.57M | 9.30M | 3.73M | 5.12M | 1.95M |
BioCardia Technical Analysis
Negative
1.19
Price Trends
1.06
Negative
1.00
Negative
1.09
Negative
Market Momentum
-0.03
Positive
41.01
Neutral
35.79
Neutral
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 1.19 is above the 20-day moving average (MA) of 1.00, above the 50-day MA of 1.06, and above the 200-day MA of 1.09, indicating a bearish trend. The MACD of -0.03 indicates Positive momentum. The RSI at 41.01 is Neutral, neither overbought nor oversold. The STOCH value of 35.79 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for BCDA.
BioCardia Risk Analysis
BioCardia disclosed 70 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% | |
47 Neutral | $10.62M | -0.62 | -162.75% | ― | 123.63% | 83.96% | |
46 Neutral | $13.94M | -1.21 | -569.36% | ― | ― | 63.72% | |
45 Neutral | $31.73M | -0.55 | 142.25% | ― | -58.14% | 47.25% | |
42 Neutral | $2.16M | -0.08 | -100.19% | ― | ― | 95.51% | |
27 Underperform | $12.49M | -0.40 | 144.63% | ― | -23.95% | 30.12% |
* Healthcare Sector Average
BCDA
BioCardia
0.92
-0.39
-29.69%
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CELU
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REVB
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3.79
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ICU
SeaStar Medical Holding
2.41
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CDIO
Cardio Diagnostics Holdings
1.69
-2.22
-56.78%
BioCardia Corporate Events
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances Helix Catheter Toward FDA Clearance
Positive
Oct 19, 2026
On October 19, 2026, BioCardia announced that the U.S. FDA accepted its revised De Novo pre-submission package for marketing clearance of the Helix transendocardial delivery catheter. The acceptance followed a series of interactions with regulator...
Business Operations and StrategyRegulatory Filings and Compliance
BioCardia Advances CardiAMP HF II Heart Failure Trial
Positive
Oct 7, 2026
On October 7, 2026, BioCardia announced it would present the design of its CardiAMP HF II trial at the Heart Failure Society of America Annual Scientific Meeting, held in Phoenix from October 9–12, 2026. The poster details a multicenter, dou...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Submits Revised FDA De Novo for Helix
Positive
Oct 1, 2026
On October 1, 2026, BioCardia reported it had completed a revised De Novo Pre-Submission to the FDA’s Center for Devices and Radiological Health under the Q-Submission program, seeking marketing approval for its Helix catheter for therapeuti...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances Regulatory Milestones for Cardiovascular Therapies
Positive
Sep 23, 2026
On September 23, 2026, BioCardia reported progress on key regulatory milestones for its cardiovascular therapeutics and delivery systems in Japan and the United States. The company is working toward a Shonin pre-market submission to Japan’s ...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Highlights Therapeutic Pipeline at Investor Conference
Positive
Sep 10, 2026
On September 10, 2026, BioCardia announced that President and CEO Peter Altman will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York, held September 14-16, 2026. The prerecorded presentation, available to confere...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances Helix Catheter Toward De Novo Approval
Positive
Aug 24, 2026
On August 24, 2026, BioCardia announced that the U.S. Food and Drug Administration had confirmed the final meeting minutes from a Pre-Submission review of its Helix Transendocardial Delivery Catheter System. The FDA’s acceptance of the minut...
Delistings and Listing ChangesRegulatory Filings and Compliance
BioCardia Receives Nasdaq Notice on Minimum Bid Price
Negative
Aug 21, 2026
On August 19, 2026, BioCardia disclosed that it had received a notice from Nasdaq after its common stock traded below the $1.00 minimum bid price requirement for 30 consecutive business days, triggering a 180‑day grace period through Februar...
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.