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BioCardia Inc (BCDA)
NASDAQ:BCDA
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BioCardia (BCDA) AI Stock Analysis

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BCDA

BioCardia

(NASDAQ:BCDA)

Rating:50Neutral
Price Target:
$2.00
▼(-2.91% Downside)
BioCardia's overall stock score reflects significant financial challenges, with ongoing losses and reliance on external financing. However, positive developments in clinical trials and strategic partnerships provide potential upside. The stock's technical indicators are mixed, and valuation remains speculative due to negative earnings.
Positive Factors
Financial Performance
Biocardia announced financial results with an EPS better than the analyst's estimate, indicating better-than-expected financial performance.
Financial Stability
The company has enough cash to fund ongoing operations through the first quarter of 2025, providing financial stability in the near term.
New Product
Morph DNA Introducer now commercially available, providing new revenue stream.
Negative Factors
Clinical Trial
DSMB determined that the study would not meet the primary Finkelstein Schoenfeld composite endpoint and recommended to pause enrollment.
Regulatory Challenges
PMDA willing to review CardiAMP HF data ahead of submission for approval in Japan.

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 development and commercialization of its cell therapy products. The company aims to monetize its innovations through clinical trial partnerships, licensing agreements, and potential future product sales. Key revenue streams include funding from clinical trials, grants, and collaborations with other pharmaceutical and biotechnology companies to advance its research and development. Additionally, successful regulatory approvals and subsequent market entry of its therapies could lead to significant sales revenue. Partnerships with healthcare institutions and research organizations also play a crucial role in driving the company's earnings and expanding its market reach.

BioCardia Earnings Call Summary

Earnings Call Date:Aug 11, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 05, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in clinical trials and regulatory pathways, particularly in Japan, with promising partnership discussions. However, increased R&D expenses, a rise in net loss, and low cash reserves present challenges. The sentiment is cautiously optimistic with a focus on regulatory approvals and strategic partnerships.
Q2-2025 Updates
Positive Updates
CardiAMP Heart Failure Trial Success
The CardiAMP Heart Failure treatment group showed lower incidence of all-cause death and nonfatal MACE compared to the control group over a 24-month period. Additionally, the composite endpoint of all-cause death, nonfatal MACE, and quality of life was statistically significant in patients with elevated NT-proBNP, with a p-value of 0.02.
Regulatory Progress in Japan
BioCardia has submitted the clinical package of the CardiAMP Heart Failure trial to Japan's PMDA and anticipates an in-person meeting in Q4 2025, potentially leading to market entry approval in Japan.
Data Safety Monitoring Board Review Success
A successful data safety monitoring board review was conducted for the CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure (BCDA-03) program.
Partnership Opportunities
Active discussions are ongoing for partnerships involving the Helix biotherapeutic delivery platform and the Morph DNA technology, with interest from firms in the cardiac electrophysiology market.
Negative Updates
Increased R&D Expenses
Research and development expenses increased to $1.4 million for the 3 months ended June 2025 from $0.8 million in the same period in 2024, driven by trial closeout and regulatory activities.
Net Loss Increase
Net loss was approximately $2.0 million for the 3 months ended June 2025, up from $1.6 million for the same period in 2024, largely due to increased R&D expenses.
Cash and Cash Equivalents
The company ended the quarter with only $980,000 in cash and cash equivalents, requiring additional financing activities.
Company Guidance
In the recent BioCardia conference call, several key metrics and developments were discussed regarding their ongoing and future activities. The CardiAMP Heart Failure trial showed promising results, with the treatment group experiencing a lower incidence of all-cause death and nonfatal major adverse cardiac events (MACE) compared to the control group over 24 months, with a p-value of 0.17. A statistically significant improvement in a composite endpoint was observed in a subgroup with elevated NT-proBNP, with a p-value of 0.02. BioCardia is pursuing regulatory approval in Japan and the United States, with a crucial meeting with Japan's PMDA scheduled for mid-Q4 2025, potentially paving the way for market entry. The company is also focusing on their Helix biotherapeutic delivery system, seeking FDA approval via the de novo 510(k) pathway. Financially, BioCardia reported an increase in R&D expenses to $1.4 million for Q2 2025, up from $0.8 million in Q2 2024, while SG&A expenses decreased to $0.7 million from $0.9 million over the same period. The company's cash and cash equivalents totaled $980,000 at quarter's end, with additional funds raised through stock sales. BioCardia aims to maintain efficient resource use and is exploring potential partnerships to enhance shareholder value.

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, while the balance sheet indicates high leverage risks. Cash flow is 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 Revenue58.00K58.00K477.00K1.35M1.01M145.00K
Gross Profit-431.00K-372.00K66.00K975.00K375.00K141.00K
EBITDA-8.71M-7.93M-11.56M-11.82M-12.57M-14.44M
Net Income-8.79M-7.95M-11.57M-11.91M-12.62M-15.00M
Balance Sheet
Total Assets2.09M3.72M2.99M9.79M15.72M23.42M
Cash, Cash Equivalents and Short-Term Investments980.00K2.37M1.10M7.36M12.87M21.41M
Total Debt745.00K951.00K1.31M1.63M1.87M614.00K
Total Liabilities3.98M2.89M4.59M4.90M5.34M4.25M
Stockholders Equity-1.89M837.00K-1.60M4.89M10.38M19.18M
Cash Flow
Free Cash Flow-8.46M-8.03M-9.99M-10.63M-10.48M-12.39M
Operating Cash Flow-8.45M-8.03M-9.97M-10.56M-10.37M-12.36M
Investing Cash Flow-4.00K-6.00K-12.00K-70.00K-116.00K-32.00K
Financing Cash Flow8.01M9.30M3.73M5.12M1.95M28.21M

BioCardia Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price2.06
Price Trends
50DMA
2.07
Negative
100DMA
2.16
Negative
200DMA
2.23
Negative
Market Momentum
MACD
>-0.01
Negative
RSI
56.99
Neutral
STOCH
91.82
Negative
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 2.06 is above the 20-day moving average (MA) of 1.90, below the 50-day MA of 2.07, and below the 200-day MA of 2.23, indicating a neutral trend. The MACD of >-0.01 indicates Negative momentum. The RSI at 56.99 is Neutral, neither overbought nor oversold. The STOCH value of 91.82 is Negative, 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
52
Neutral
$9.96M-81.33%-62.68%23.94%
51
Neutral
$7.95B-0.40-42.50%2.21%22.29%-1.85%
50
Neutral
$11.95M-737.89%-100.00%60.53%
48
Neutral
$11.26M-238.26%-57.69%63.76%
48
Neutral
$11.60M
48.91%
$379.87M-371.02%
48
Neutral
$12.76M-137.09%247.62%-7.66%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BCDA
BioCardia
2.06
-0.35
-14.52%
ATON
AlphaTON Capital
5.09
2.25
79.23%
ETHZ
ETHZilla Corporation
2.31
0.43
22.87%
BRTX
BioRestorative Therapies
1.60
0.14
9.59%
LYRA
Lyra Therapeutics
6.85
-6.47
-48.57%
BOLT
Bolt Biotherapeutics
5.19
-7.44
-58.91%

BioCardia Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Partners with CART-Tech for Heart3D™ Imaging
Positive
Aug 13, 2025

On August 13, 2025, BioCardia, Inc. and CART-Tech, B.V. announced an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging, aimed at enhancing cardiac biotherapeutic delivery and biopsy procedures. The system, which fuses two-dimensional x-ray images with three-dimensional anatomical heart models, is initially intended for research use and may later be approved for standard clinical practice. This partnership leverages both companies’ expertise and intellectual property, with BioCardia securing exclusive distribution rights for biotherapeutic delivery worldwide and cardiac biopsy in the U.S. The collaboration is expected to improve procedural planning and real-time image precision, potentially generating significant revenue if adopted as a standard of care.

Product-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Updates Regulatory Timeline for Helix System
Neutral
Aug 4, 2025

On August 4, 2025, BioCardia, Inc. announced updates on the regulatory approval timeline for its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. The company plans to submit a DeNovo 510(k) application for the Helix system to the FDA in Q3 2025, leveraging its safety and performance in numerous clinical studies. Additionally, BioCardia aims to discuss the approval pathway for CardiAMP Cell Therapy for ischemic heart failure with the FDA in Q4 2025, highlighting its previous Breakthrough Designation and clinical trial results. A clinical consultation with Japan’s PMDA is also expected in Q4 2025, potentially facilitating market entry in Japan. These developments could significantly impact BioCardia’s market positioning and provide new opportunities for stakeholders.

Product-Related AnnouncementsRegulatory Filings and Compliance
BioCardia Submits CardiAMP Therapy for PMDA Review
Positive
Jul 24, 2025

On July 24, 2025, BioCardia announced the submission of its CardiAMP autologous cell therapy for heart failure to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation. This submission is a crucial step towards potential regulatory approval in Japan, a significant market for advanced heart failure treatments. The consultation will involve a comprehensive review of clinical data from the CardiAMP HF trial, assessing the therapy’s efficacy, safety, and fit within the Japanese healthcare system. Successful alignment with PMDA could lead to market entry in Japan and a subsequent post-marketing study, enhancing BioCardia’s industry positioning and offering new opportunities for collaboration.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Launches Phase 3 CardiAMP HF II Trial
Positive
Jul 16, 2025

On July 16, 2025, BioCardia announced that Henry Ford Health in Detroit, Michigan, has begun enrolling patients with ischemic heart failure in the company’s pivotal Phase 3 CardiAMP HF II trial. This trial is a confirmatory study of autologous bone marrow-derived mononuclear cell therapy, aiming to promote microvascular repair and improve heart function in patients with ischemic heart failure. The trial seeks to confirm the safety and efficacy results observed in previous studies and could potentially enhance treatment options for patients with heart failure.

Private Placements and FinancingRegulatory Filings and Compliance
BioCardia Completes Private Placement Agreement
Neutral
Jul 2, 2025

On June 30, 2025, BioCardia, Inc. completed a private placement agreement with institutional buyers and company insiders, raising approximately $570,000. The funds will be used for general corporate purposes, and the company plans to register the shares for resale with the SEC by July 10, 2025.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Secures Patent for Innovative Catheter System
Positive
Jun 25, 2025

On June 25, 2025, BioCardia announced the granting of US Patent No. 12,311,127 for its ‘Radial and Trans-endocardial Delivery Catheter’ by the United States Patent Office. This patent covers BioCardia’s minimally invasive catheter systems designed to deliver biologic therapies to the heart, enhancing treatment precision and safety. The Helix catheter system, integral to the company’s CardiAMP Cell Therapy program, is expected to significantly impact the treatment of ischemic cardiomyopathies and heart failure, potentially improving patient outcomes and facilitating the transition from development to commercialization.

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: Sep 06, 2025