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BioCardia Inc (BCDA)
NASDAQ:BCDA

BioCardia (BCDA) AI Stock Analysis

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BCDA

BioCardia

(NASDAQ:BCDA)

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Neutral 45 (OpenAI - 5.2)
Rating:45Neutral
Price Target:
$1.00
▼(-13.79% Downside)
Action:ReiteratedDate:02/04/26
The score is primarily constrained by very weak financial performance (no meaningful revenue, ongoing losses, and sustained cash burn), which elevates funding risk. Technicals also remain bearish with the stock below major moving averages, despite oversold signals. Positive clinical/regulatory updates and stated runway into 2026 provide some support, but do not outweigh the current financial and trend headwinds.
Positive Factors
FDA Breakthrough Designation
FDA Breakthrough designation formally recognizes CardiAmp's potential to address an unmet need, accelerating review and facilitating deeper regulator engagement. This durable regulatory status strengthens partnership prospects, may shorten time to market, and supports payer/regulatory dialogue if Phase III succeeds.
Phase III enrollment progressing
Enrollment and randomization in a 250‑patient Phase III confirmatory trial mark a transition to pivotal evidence generation. Sustained site activation and patient flow materially de‑risk the development program, improving the odds of regulatory approval and eventual commercial adoption if trial endpoints are met.
Advancing Japan regulatory pathway (PMDA)
Progressing to formal PMDA consultation opens a distinct approval route in Japan, providing geographic diversification and potential incremental revenue. Successful PMDA engagement can enable country‑specific labeling and reimbursement, strengthening long‑term commercial optionality and partner interest.
Negative Factors
No meaningful revenue
With TTM revenue at $0 and a multi‑year decline in reported sales, BioCardia has not established a commercial revenue base. Lack of operating income means the business cannot self‑fund development, heightening dependence on external financing and increasing execution and dilution risk over the medium term.
Persistent cash burn
Sustained negative operating and free cash flow of roughly -$7.5M TTM underscores ongoing funding needs. Even with reported runway into 2026, continued burn requires further capital or non‑dilutive grants to complete pivotal programs; funding uncertainty is a structural constraint on operations.
Weakened equity base increases financing risk
A materially eroded equity cushion over several years leaves the company with limited capital resilience. A thinner balance sheet reduces ability to absorb clinical or regulatory setbacks, raises the probability of dilutive financings, and constrains strategic optionality for long‑term program support.

BioCardia (BCDA) vs. SPDR S&P 500 ETF (SPY)

BioCardia Business Overview & Revenue Model

Company DescriptionBioCardia, 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 heart failure and chronic myocardial ischemia; and allogeneic cell therapy for cardiac and pulmonary disease. The company is also developing allogeneic cells therapeutic platform, an investigational culture expanded bone marrow derived mesenchymal cell therapy, which is in Phase I/II trial for the treatment of ischemic systolic heart failure. In addition, it offers the Helix biotherapeutic delivery system that delivers therapeutics into the heart muscle with a penetrating helical needle from within the heart; and Morph deflectable guides and sheaths. The company is based in Sunnyvale, California.
How the Company Makes MoneyBioCardia generates revenue primarily through the commercialization of its cell therapy products, which involve a combination of direct sales, partnerships with healthcare providers, and collaborations with pharmaceutical companies for clinical trials and product development. The company may also receive funding through grants and investments aimed at advancing its research and development efforts. Key revenue streams include sales of its CardiAMP and CardiALLO systems, as well as potential royalties from licensing agreements and partnerships that allow other entities to utilize its technologies in their own therapeutic developments.

BioCardia Earnings Call Summary

Earnings Call Date:Nov 12, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Apr 01, 2026
Earnings Call Sentiment Positive
The earnings call highlighted significant progress in clinical trials, regulatory advancements, and partnerships, suggesting a strong potential for future growth. However, increased expenses and a reported net loss present ongoing financial challenges.
Q3-2025 Updates
Positive Updates
Positive Preliminary Clinical Consultation in Japan
BioCardia announced a positive preliminary clinical consultation with Japan's pharmaceutical and medical device agency (PMDA) for the CardiAmp system, indicating potential for market entry in Japan.
Advancement of CardiAmp Heart Failure II Trial
The CardiAmp Heart Failure II confirmatory Phase III trial is accelerating with four centers actively enrolling and showing promising results in patients with elevated NT proBNP.
CardiAmp Cell Therapy Receives FDA Breakthrough Designation
The CardiAmp system has received FDA breakthrough designation based on clinical results, highlighting its potential to treat ischemic heart failure patients effectively.
Partnership for Heart 3D Fusion Imaging
BioCardia announced a partnership with CAR TECH for developing and commercializing Heart 3D Fusion Imaging, showing promising results in animal studies.
Non-Dilutive Funding Expectations
BioCardia expects non-dilutive funding to complete the Phase I-II trial for its BCDA-03 program in 2026, with promising federal grant funding discussions.
Negative Updates
Increased R&D Expenses
Research and development expenses increased to $936,000 from $931,000 in the previous year and are expected to increase modestly due to ongoing clinical trials and regulatory activities.
Net Loss Reported
BioCardia reported a net loss of $1.5 million for the third quarter of 2025, compared to $1.7 million in the same period in 2024.
Challenges in Clinical Site Onboarding
Clinical research sites are requesting higher startup costs due to reduced overhead funding, which may affect site onboarding for the CardiAmp Heart Failure II trial.
Company Guidance
During the third quarter of 2025, BioCardia provided crucial updates on its ongoing clinical programs and financial status. The company reported a net loss of $1.5 million, a reduction from $1.7 million in the same period of 2024, and ended the quarter with $5.3 million in cash, ensuring operational runway into 2026 without additional financing. They highlighted advancements in their CARDI AMP Heart Failure II trial, a Phase III study enrolling 250 patients, with four centers actively participating and three having randomized their first patients. The trial is supported by Medicare and Medicaid Services, focusing on a composite primary outcome measure. BioCardia also emphasized progress with regulatory discussions in Japan for their CardiAmp system, citing a positive preliminary consultation with the PMDA. In terms of research and development, expenses rose to $936,000, primarily driven by new enrollments and regulatory activities. The company anticipates FDA submission for their Helix biotherapeutic delivery system in Q4 2025, as well as potential non-dilutive funding for their CARDI allo program in 2026.

BioCardia Financial Statement Overview

Summary
Early-stage profile with minimal revenue (TTM $0) and persistent losses (TTM EBIT about -$8.6M) plus significant cash burn (TTM operating/FCF about -$7.5M). Balance sheet leverage is relatively low (debt-to-equity ~0.24), but the equity base has been pressured over time, increasing financing risk despite some narrowing of losses versus prior years.
Income Statement
6
Very Negative
BCDA remains in a heavy loss-making phase with no meaningful revenue base: TTM (Trailing-Twelve-Months) revenue is $0 and annual revenue fell sharply from $1.35M (2022) to $0.48M (2023) to $0.06M (2024). Profitability is weak with consistently large operating losses (TTM EBIT of about -$8.6M) and negative gross profit in most periods, indicating the cost structure is far ahead of current commercialization. A modest positive is that losses have narrowed versus 2022–2023 levels, but the overall earnings profile is still highly challenged.
Balance Sheet
34
Negative
Leverage is currently low-to-moderate, with TTM total debt of ~$0.64M against stockholders’ equity of ~$2.63M (debt-to-equity ~0.24), an improvement from 2024 when debt-to-equity was above 1.0. However, the balance sheet has weakened over the multi-year period as equity declined materially (from ~$19.2M in 2020 to ~$0.84M in 2024, then rebounding to ~$2.63M TTM), and losses drive extremely poor returns on equity (TTM ROE is deeply negative). The company is not highly levered, but ongoing losses and a smaller equity cushion increase financial risk.
Cash Flow
8
Very Negative
Cash burn remains substantial and persistent: TTM operating cash flow is about -$7.5M and free cash flow is about -$7.5M, reflecting continued funding needs. While burn has improved versus 2022–2023 levels (when operating cash flow was roughly -$10M to -$10.6M), free cash flow growth is negative TTM and cash generation is not yet in sight given minimal revenue. Free cash flow tracks net losses closely, underscoring that losses are translating into real cash outflows rather than being primarily non-cash accounting effects.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.0058.00K477.00K1.35M1.01M145.00K
Gross Profit-4.42M-4.33M-7.25M-7.48M375.00K141.00K
EBITDA-8.44M-7.93M-11.56M-11.82M-12.57M-14.44M
Net Income-8.54M-7.95M-11.57M-11.91M-12.62M-15.00M
Balance Sheet
Total Assets6.15M3.72M2.99M9.79M15.72M23.42M
Cash, Cash Equivalents and Short-Term Investments5.29M2.37M1.10M7.36M12.87M21.41M
Total Debt638.00K951.00K1.31M1.63M1.87M614.00K
Total Liabilities3.52M2.89M4.59M4.90M5.34M4.25M
Stockholders Equity2.63M837.00K-1.60M4.89M10.38M19.18M
Cash Flow
Free Cash Flow-7.51M-8.03M-9.99M-10.63M-10.48M-12.39M
Operating Cash Flow-7.51M-8.03M-9.97M-10.56M-10.37M-12.36M
Investing Cash Flow-2.00K-6.00K-12.00K-70.00K-116.00K-32.00K
Financing Cash Flow7.87M9.30M3.73M5.12M1.95M28.21M

BioCardia Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.16
Price Trends
50DMA
1.28
Negative
100DMA
1.33
Negative
200DMA
1.70
Negative
Market Momentum
MACD
-0.04
Positive
RSI
37.41
Neutral
STOCH
21.74
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 1.16 is below the 20-day moving average (MA) of 1.22, below the 50-day MA of 1.28, and below the 200-day MA of 1.70, indicating a bearish trend. The MACD of -0.04 indicates Positive momentum. The RSI at 37.41 is Neutral, neither overbought nor oversold. The STOCH value of 21.74 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 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
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%
48
Neutral
$8.96M-0.23-81.97%-46.88%34.83%
45
Neutral
$12.26M-0.67-317.47%-100.00%58.50%
44
Neutral
$68.82M-0.06-371.02%
44
Neutral
$2.44M-0.18-207.73%1.70%-111.67%
42
Neutral
$5.99M>-0.01
41
Neutral
$2.48M-0.06-404.48%-59.21%68.97%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BCDA
BioCardia
1.13
-1.02
-47.44%
ATON
AlphaTON Capital
0.42
-4.18
-90.97%
ETHZ
ETHZilla Corporation
3.61
-9.49
-72.44%
BRTX
BioRestorative Therapies
0.22
-1.38
-86.38%
LYRA
Lyra Therapeutics
1.45
-9.05
-86.19%
BOLT
Bolt Biotherapeutics
5.05
-4.68
-48.10%

BioCardia Corporate Events

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 Therapeutics Meeting, scheduled for March 2–4, 2026, in Boston, Massachusetts. The data, to be presented on March 2 by CardiAMP HF Trial National Co-Principal Investigator Dr. Amish Raval, highlight investigational autologous cell therapy aimed at curbing pathological ventricular remodeling in chronic ischemic heart failure patients with reduced ejection fraction, underscoring BioCardia’s advancing clinical profile and the growing recognition of its FDA Breakthrough-designated, catheter-based therapy, which is supported by the Maryland Stem Cell Research Fund and reimbursed by the Centers for Medicare and Medicaid Services.

The most recent analyst rating on (BCDA) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Advances CardiAMP Therapy in Japan
Positive
Dec 16, 2025

On December 16, 2025, BioCardia announced the completion of a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) for its CardiAMP Cell Therapy aimed at treating Heart Failure with Reduced Ejection Fraction (HFrEF). The PMDA has agreed to allow BioCardia to advance to a formal clinical consultation, which could lead to regulatory approval in Japan if the data is deemed sufficient. The CardiAMP Cell Therapy, which uses a patient’s own bone marrow cells, has shown positive outcomes in clinical trials, including improved survival rates and reduced major adverse cardiovascular events. This development could significantly impact BioCardia’s operations and its positioning in the cardiovascular therapeutics market.

The most recent analyst rating on (BCDA) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Executive/Board ChangesShareholder Meetings
BioCardia Appoints Marvin Slosman to Board of Directors
Neutral
Dec 3, 2025

On December 2, 2025, BioCardia, Inc. announced the appointment of Marvin Slosman to its Board of Directors, effective immediately, with his term expiring at the 2028 Annual Meeting of Shareholders. Mr. Slosman, who is also the CEO of InspireMD, brings extensive experience in interventional cardiology and global market expansion. His appointment follows the completion of Dr. Richard Krasno’s term, who has been instrumental in guiding the company through significant milestones. The company’s Annual Meeting on the same day saw the election of Class III directors and approval of key proposals, including amendments to the 2016 Equity Incentive Plan and ratification of PKF San Diego, LLP as the independent accounting firm.

The most recent analyst rating on (BCDA) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Executive/Board Changes
BioCardia Appoints New VP of Quality
Positive
Nov 24, 2025

On November 24, 2025, BioCardia, Inc. announced the appointment of Farhan Shahab as Vice President of Quality. Shahab brings over 25 years of experience in quality management and regulatory roles from various medical and health companies. His expertise is expected to enhance BioCardia’s efforts in commercializing its investigational products, potentially accelerating their market readiness and strengthening the company’s leadership team.

The most recent analyst rating on (BCDA) stock is a Buy with a $25.00 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
BioCardia Enrolls First Patient in Phase 3 Trial
Positive
Nov 10, 2025

On November 10, 2025, BioCardia announced the enrollment of the first patient at Henry Ford Health in its Phase 3 CardiAMP HF II clinical trial for ischemic heart failure with reduced ejection fraction. This trial aims to confirm the safety and efficacy of the CardiAMP autologous cell therapy, which previously showed promising results in reducing mortality and improving quality of life for patients. The trial’s success could address significant clinical needs for the approximately 2 million patients in the U.S. and EU suffering from this condition, potentially impacting patient care and the healthcare system.

The most recent analyst rating on (BCDA) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

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.Date of analysis: Feb 04, 2026