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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 46 (OpenAI - 4o)
Rating:46Neutral
Price Target:
$1.50
▲(18.11% Upside)
BioCardia's overall stock score is primarily impacted by its weak financial performance and valuation. Despite positive developments in clinical trials and regulatory progress, the company's ongoing financial challenges and bearish technical indicators weigh heavily on its score.
Positive Factors
Regulatory Progress in Japan
Advancing to formal clinical consultation with PMDA could lead to regulatory approval in Japan, expanding market access and enhancing long-term growth potential.
FDA Breakthrough Designation
This designation underscores the therapy's potential efficacy, accelerating development and potentially improving market positioning in treating ischemic heart failure.
Partnership for Heart 3D Fusion Imaging
The partnership could enhance BioCardia's technological capabilities, potentially leading to innovative product offerings and strengthening its competitive edge.
Negative Factors
Weak Financial Performance
Ongoing financial challenges, including negative margins, indicate instability and a challenging path to profitability, impacting long-term financial health.
High Debt-to-Equity Ratio
High leverage can strain financial flexibility and increase risk, potentially affecting the company's ability to invest in growth opportunities.
Negative Cash Flow
Dependence on external financing for cash flow needs highlights challenges in generating sufficient operating cash, posing risks to financial sustainability.

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
BioCardia's financial performance is weak, with significant challenges in profitability and financial stability. The income statement shows negative EBIT and net income margins, and the balance sheet indicates a high debt-to-equity ratio. Cash flow is consistently negative, relying heavily on financing activities.
Income Statement
12
Very Negative
BioCardia's income statement indicates significant challenges with profitability, as evidenced by consistently negative EBIT and net income margins. Revenue has been highly volatile, with a dramatic decrease over the years and a substantial dip in gross profit. This volatility, coupled with negative margins, suggests financial instability and a challenging path to profitability.
Balance Sheet
25
Negative
The balance sheet reveals a weak equity position with negative stockholders' equity in previous years, which has slightly improved to a positive figure recently. The debt-to-equity ratio is relatively high, indicating potential leverage risks. Despite an increase in cash and short-term investments, overall asset growth has been stagnant, raising concerns about long-term financial health.
Cash Flow
20
Very Negative
The cash flow statement shows consistently negative free cash flow, although there has been some improvement in operating cash flow relative to net income. High reliance on financing activities to manage cash flow needs highlights challenges in generating sufficient operating cash. This reliance on external financing can be risky if not managed carefully.
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 Price1.27
Price Trends
50DMA
1.37
Negative
100DMA
1.56
Negative
200DMA
1.93
Negative
Market Momentum
MACD
-0.02
Positive
RSI
40.40
Neutral
STOCH
19.05
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 1.27 is below the 20-day moving average (MA) of 1.39, below the 50-day MA of 1.37, and below the 200-day MA of 1.93, indicating a bearish trend. The MACD of -0.02 indicates Positive momentum. The RSI at 40.40 is Neutral, neither overbought nor oversold. The STOCH value of 19.05 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 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%
49
Neutral
$9.90M-0.23-81.97%-46.88%34.83%
48
Neutral
$5.51M-0.01
48
Neutral
$10.21M-0.76-207.73%1.70%-111.67%
46
Neutral
$13.48M-0.74-317.47%-100.00%58.50%
45
Neutral
$6.39M-0.15-404.48%-59.21%68.97%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BCDA
BioCardia
1.27
-0.74
-36.82%
ATON
AlphaTON Capital
0.72
-4.67
-86.64%
ETHZ
ETHZilla Corporation
6.90
-11.80
-63.10%
BRTX
BioRestorative Therapies
1.15
-0.37
-24.34%
LYRA
Lyra Therapeutics
3.60
-5.14
-58.81%
BOLT
Bolt Biotherapeutics
5.16
-5.06
-49.51%

BioCardia Corporate Events

Product-Related AnnouncementsBusiness Operations and StrategyRegulatory 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.

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.

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.

Product-Related AnnouncementsBusiness Operations and Strategy
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.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Advances Phase 3 CardiAMP HF II Trial
Positive
Oct 30, 2025

On October 30, 2025, BioCardia, Inc. announced that the University of Wisconsin School of Medicine and Public Health enrolled its first patient in the ongoing Phase 3 CardiAMP HF II clinical trial. This trial aims to confirm the safety and efficacy of CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction. The study, which involves 250 patients, utilizes a composite primary outcome measure and incorporates advancements in cell population analysis and delivery systems. The enrollment at this prestigious cardiology center is expected to strengthen the trial and potentially broaden the availability of this therapy.

Shareholder Meetings
BioCardia Sets Record Date for Annual Meeting
Neutral
Oct 7, 2025

BioCardia, Inc. has announced that its 2025 Annual Meeting of Stockholders will take place on December 2, 2025, at 9:00 a.m. Pacific Time in Palo Alto, California. The company has set October 8, 2025, as the record date for stockholders eligible to vote and October 17, 2025, as the deadline for stockholder proposals and nominations for the meeting, in compliance with SEC regulations.

Delistings and Listing ChangesPrivate Placements and FinancingRegulatory Filings and Compliance
BioCardia Regains Nasdaq Compliance, Secures Continued Listing
Positive
Oct 2, 2025

On October 2, 2025, BioCardia, Inc. announced it has regained compliance with Nasdaq’s Listing Rule 5550(b)(1), ensuring its continued listing on the Nasdaq Stock Market. This achievement follows BioCardia’s efforts to strengthen its financial position by raising capital to support the development of its therapeutic candidates and advance its approved products.

Business Operations and StrategyRegulatory Filings and Compliance
BioCardia’s Positive Consultation with Japan’s PMDA
Positive
Sep 22, 2025

On September 22, 2025, BioCardia announced a positive preliminary clinical consultation with Japan’s PMDA regarding the CardiAMP Heart Failure Trial results. This meeting was a preparatory step for a formal consultation on the clinical data’s acceptability for approval submission. The PMDA requested additional information on various aspects of the trial, and BioCardia plans to address these queries before a formal consultation later in the year. This development could potentially enhance BioCardia’s position in the market by enabling access for patients with significant therapeutic needs.

Private Placements and Financing
BioCardia Raises $5.1 Million Through Stock Sale
Positive
Sep 19, 2025

On September 19, 2025, BioCardia, Inc. completed a significant financial transaction by selling 4,800,000 shares of common stock and accompanying warrants, raising approximately $5.1 million in net proceeds. This strategic move, involving key company directors and executive officers, is expected to bolster the company’s financial position and potentially impact its market operations by restricting certain stock issuance activities until March 2026.

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: Dec 19, 2025