BioCardia Inc (BCDA)
NASDAQ:BCDA
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BioCardia
(NASDAQ:BCDA)
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Rating:46Neutral
Price Target:
$1.00
▼(-17.36% Downside)
Action:ReiteratedDate:04/03/26
The score is held down primarily by very weak financial performance (persistent losses and cash burn) and a technically weak price trend (below key moving averages with negative MACD). Offsetting these is a moderately positive but high-risk earnings outlook driven by multiple near-term regulatory and clinical catalysts, tempered by limited cash runway and endpoint/regulatory uncertainty.
Positive Factors
Regulatory progress for Helix transendocardial catheter
Acceptance of a Helix pre-sub by FDA CDRH and scheduled substantive feedback materially reduces device development uncertainty. An approved percutaneous intramyocardial delivery platform would de‑risk BioCardia’s therapy pathway, enable faster commercial access, and create a durable platform for partners and licensing.
Negative Factors
Limited cash runway relative to burn
Cash of roughly $2.5M versus an annual operational burn near $7.5M implies near‑term financing needs. Persistent reliance on external capital raises execution risk for trials, regulatory submissions, and commercialization, increasing likelihood of dilution or partnerships that could constrain strategic optionality.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory progress for Helix transendocardial catheter
Acceptance of a Helix pre-sub by FDA CDRH and scheduled substantive feedback materially reduces device development uncertainty. An approved percutaneous intramyocardial delivery platform would de‑risk BioCardia’s therapy pathway, enable faster commercial access, and create a durable platform for partners and licensing.
Read all positive factors
BioCardia (BCDA) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$13.24M
Dividend YieldN/A
Average Volume (3M)1.15M
Price to Earnings (P/E)―
Beta (1Y)1.65
Revenue Growth-100.00%
EPS Growth58.50%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)0.00
Shares Outstanding10,940,372
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 Cap0.38
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-1.58
Enterprise Value/Ebitda-0.63
Forecast
1Y Price Target
$15.50Price Target Upside1180.99% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)-0.82
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:Mar 24, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 13, 2026
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.Positive Updates
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.
Negative Updates
Primary Echocardiographic Endpoints Not Statistically Significant in Full Cohort
Across the complete trial population the reductions in left ventricular volumes approached but did not meet conventional statistical significance (p≈0.06 for diastolic and p≈0.09 for systolic measures), meaning the strongest statistical support was limited to the prespecified high‑NT‑proBNP subgroup.
Read all updates
Q4-2025 Updates
Positive
Negative
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.
Read all positive updates
Company Guidance
Management provided clear near‑term regulatory and financial guidance: they plan to imminently file a Q‑sub with FDA CBER (estimating ~45‑day Sprint feedback), have a formal PMDA consultation in Japan, expect substantive FDA feedback on the Helix de‑novo device pathway, and will present CardiAMP data at EuroPCR in May—four catalysts next quarter. Clinically, across three trials they reported LV end‑diastolic and end‑systolic volume p‑values of 0.06 and 0.09 in the full cohort and prespecified NT‑proBNP–elevated subgroup reductions >20 mL/m^2 and >15 mL/m^2 with p=0.02 and p=0.01 respectively, targeting roughly 1,000,000 U.S. and 150,000 Japan patients with ischemic heart failure with reduced ejection fraction (≈10% annual mortality). Financially, total expense rose ≈3% to $8.3M in 2025 (from $8.1M), R&D increased 13% to $5.0M (from $4.4M), SG&A fell 10% to $3.3M (from $3.7M), net loss was ~$8.2M (vs $7.9M), net cash used in operations was ~$7.5M (vs $7.9M), and year‑end cash was ~$2.5M (vs $2.4M); they expect modestly higher R&D in 2026, SG&A roughly flat, relatively consistent cash burn, and post‑marketing studies (likely “many hundreds” of patients) tied to any approval path.BioCardia Financial Statement Overview
Summary
Income Statement
8
Very Negative
Balance Sheet
32
Negative
Cash Flow
10
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 58.00K | 477.00K | 1.35M | 1.01M |
| Gross Profit | -505.00K | -4.33M | -7.25M | -7.48M | 375.00K |
| EBITDA | -7.77M | -7.93M | -11.56M | -11.82M | -12.57M |
| Net Income | -8.23M | -7.95M | -11.57M | -11.91M | -12.62M |
Balance Sheet | |||||
| Total Assets | 3.41M | 3.72M | 2.99M | 9.79M | 15.72M |
| Cash, Cash Equivalents and Short-Term Investments | 2.50M | 2.37M | 1.10M | 7.36M | 12.87M |
| Total Debt | 528.00K | 951.00K | 1.31M | 1.63M | 1.87M |
| Total Liabilities | 2.52M | 2.89M | 4.59M | 4.90M | 5.34M |
| Stockholders Equity | 895.00K | 837.00K | -1.60M | 4.89M | 10.38M |
Cash Flow | |||||
| Free Cash Flow | -7.44M | -8.03M | -9.99M | -10.63M | -10.48M |
| Operating Cash Flow | -7.44M | -8.03M | -9.97M | -10.56M | -10.37M |
| Investing Cash Flow | -7.00K | -6.00K | -12.00K | -70.00K | -116.00K |
| Financing Cash Flow | 7.57M | 9.30M | 3.73M | 5.12M | 1.95M |
BioCardia Technical Analysis
Neutral
1.21
Price Trends
1.21
Negative
1.28
Negative
1.53
Negative
Market Momentum
-0.01
Negative
50.19
Neutral
53.16
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BCDA, the sentiment is Neutral. The current price of 1.21 is below the 20-day moving average (MA) of 1.21, below the 50-day MA of 1.21, and below the 200-day MA of 1.53, indicating a bearish trend. The MACD of -0.01 indicates Negative momentum. The RSI at 50.19 is Neutral, neither overbought nor oversold. The STOCH value of 53.16 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for BCDA.
BioCardia Risk Analysis
BioCardia disclosed 27 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 | $8.84M | -0.31 | -97.58% | ― | -46.88% | 34.83% | |
46 Neutral | $13.24M | -1.01 | -317.47% | ― | -100.00% | 58.50% | |
44 Neutral | $6.54M | -0.82 | -420.31% | ― | 1.70% | -111.67% | |
41 Neutral | $7.44M | -0.33 | -925.11% | ― | ― | ― | |
39 Underperform | $889.39K | -1.65 | 1211.14% | ― | -59.21% | 68.97% |
* Healthcare Sector Average
BCDA
BioCardia
1.21
-0.79
-39.50%
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AlphaTON Capital
0.32
-4.70
-93.69%
BRTX
BioRestorative Therapies
0.26
-1.58
-86.09%
LYRA
Lyra Therapeutics
0.50
-4.21
-89.36%
BOLT
Bolt Biotherapeutics
4.60
-2.18
-32.15%
BioCardia Corporate Events
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...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances FDA Pathway for Helix Delivery Catheter
Positive
Feb 10, 2026
On February 10, 2026, BioCardia reported it had completed a Pre-Submission to the U.S. Food and Drug Administration under the Q-Submission program seeking approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and...
Business Operations and StrategyProduct-Related Announcements
BioCardia’s CardiAMP Heart Failure Data Selected for LBCT
Positive
Feb 3, 2026
On February 3, 2026, BioCardia announced that echocardiography data from its CardiAMP Cell Therapy for the treatment of heart failure were accepted for a Late Breaking Clinical Trial Oral Presentation at the Technology and Heart Failure Therapeuti...
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.