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BioCardia Inc (BCDA)
NASDAQ:BCDA

BioCardia (BCDA) AI Stock Analysis

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BioCardia

(NASDAQ:BCDA)

Rating:50Neutral
Price Target:
$2.00
▼(-10.31%Downside)
BioCardia's stock score is impacted primarily by its weak financial performance and concerning valuation metrics, which highlight ongoing profitability and stability challenges. Despite positive clinical and strategic developments, these financial weaknesses weigh heavily on the overall score.
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 through a combination of product sales, licensing agreements, and collaborations. The company primarily aims to commercialize its cell therapy candidates, such as CardiAMP and CardiALLO, upon successful completion of clinical trials and regulatory approvals. BioCardia also earns revenue from licensing its proprietary biotherapeutic delivery platform to other companies in the biopharmaceutical sector. Additionally, the company engages in partnerships and collaborations that provide research funding and milestone-based payments, further contributing to its revenue streams. These partnerships often align with BioCardia's strategic goals in advancing regenerative medicine solutions for cardiovascular diseases.

BioCardia Earnings Call Summary

Earnings Call Date:May 14, 2025
(Q1-2025)
|
% Change Since: -19.49%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in clinical trials and regulatory preparation, emphasizing the potential impact of BioCardia's therapies. However, financial challenges, including increased expenses and limited cash reserves, present ongoing challenges.
Q1-2025 Updates
Positive Updates
Successful CardiAMP Heart Failure Trial
The CardiAMP Heart Failure Trial demonstrated safety and meaningful benefits for heart failure patients, potentially addressing a significant unmet clinical need for approximately 1 million Americans.
New Trial Enrollments and Progress
The CardiAMP Heart Failure II Trial is actively enrolling patients at three clinical sites with plans to be fully enrolled over the next two years, aiming to confirm previous results and enhance enrollment.
Data Safety Monitoring Board Review Success
The CardiALLO allogeneic mesenchymal stem cell therapy for ischemic heart failure passed a Data Safety Monitoring Board review, with no adverse events in the low-dose cohort.
Helix Biotherapeutic Delivery System Advances
Preparation for submission for approval of the Helix biotherapeutic delivery system is underway, with potential to be the first approved transendocardial biotherapeutic delivery system in the U.S.
Approval of Morph DNA Platform
The FDA approved the Morph DNA steerable introducer platform, which is being positively received by physicians.
Negative Updates
Increased Expenses and Net Loss
Total expenses increased by $396,000 to $2.7 million in Q1 2025 compared to the same period in 2024, with a net loss of $2.7 million, up from $2.3 million in Q1 2024.
Limited Cash Reserves
The company ended the quarter with cash and cash equivalents totaling $949,000, necessitating a small financing to meet upcoming milestones.
Company Guidance
During BioCardia's first quarter 2025 earnings call, the company provided several key metrics and strategic focuses. The CardiAMP Heart Failure Trial demonstrated safety and meaningful benefits, targeting a significant clinical need for approximately 1 million Americans with heart failure, who have a 10% mortality rate per year. The company's primary focus for the second quarter is to present this data to regulatory bodies, including the FDA and Japan's PMDA, and to further engage the clinical community. The CardiAMP Heart Failure II Trial is actively enrolling at three sites, with plans for full enrollment over the next two years. Financially, total expenses rose to $2.7 million from $2.3 million year-over-year, driven by increased R&D expenses, which rose to $1.5 million due to the wrap-up of the initial trial and the initiation of the second trial. The company ended the quarter with $949,000 in cash and cash equivalents, following a modest financing to support milestones and manage a net loss of $2.7 million.

BioCardia Financial Statement Overview

Summary
BioCardia's financial performance is challenged by significant profitability issues, negative EBIT and net income margins, and high volatility in revenue. The balance sheet shows a weak equity position and high debt-to-equity ratio, indicating leverage risks. Cash flow remains negative, heavily relying on financing, which poses long-term financial health challenges.
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 Revenue-55.00K58.00K477.00K1.35M1.01M145.00K
Gross Profit-213.00K-4.33M-7.25M-10.55M375.00K141.00K
EBITDA-5.68M-7.93M-11.56M-11.82M-12.57M-14.44M
Net Income-8.39M-7.95M-11.57M-11.91M-12.62M-15.00M
Balance Sheet
Total Assets2.17M3.72M2.99M9.79M15.72M23.42M
Cash, Cash Equivalents and Short-Term Investments949.00K2.37M1.10M7.36M12.87M21.41M
Total Debt850.00K951.00K1.31M1.63M1.87M614.00K
Total Liabilities3.69M2.89M4.59M4.90M5.34M4.25M
Stockholders Equity-1.52M837.00K-1.60M4.89M10.38M19.18M
Cash Flow
Free Cash Flow-8.12M-8.03M-9.99M-10.63M-10.48M-12.39M
Operating Cash Flow-8.11M-8.03M-9.97M-10.56M-10.37M-12.36M
Investing Cash Flow-6.00K-6.00K-12.00K-70.00K-116.00K-32.00K
Financing Cash Flow8.12M9.30M3.73M5.12M1.95M28.21M

BioCardia Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.23
Price Trends
50DMA
2.27
Negative
100DMA
2.34
Negative
200DMA
2.36
Negative
Market Momentum
MACD
-0.03
Negative
RSI
51.15
Neutral
STOCH
54.42
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BCDA, the sentiment is Positive. The current price of 2.23 is above the 20-day moving average (MA) of 2.18, below the 50-day MA of 2.27, and below the 200-day MA of 2.36, indicating a neutral trend. The MACD of -0.03 indicates Negative momentum. The RSI at 51.15 is Neutral, neither overbought nor oversold. The STOCH value of 54.42 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 (65)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
65
Neutral
¥346.03B10.53-2.88%2.63%11.67%-7.08%
50
Neutral
$11.65M-737.89%-99.36%63.06%
49
Neutral
$10.74M-9999.00%-63.20%15.71%
48
Neutral
$12.38M-117.16%175.03%55.34%
40
Underperform
$10.56M-64.18%1.00%
38
Underperform
$13.41M-60.06%8.99%
31
Underperform
$11.70M-202.81%64.01%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BCDA
BioCardia
2.23
-0.74
-24.92%
LPTX
Leap Therapeutics
0.28
-1.68
-85.71%
CTXR
Citius Pharmaceuticals
1.33
-13.26
-90.88%
BRTX
BioRestorative Therapies
1.67
-0.36
-17.73%
SNSE
Sensei Biotherapeutics
8.38
-4.02
-32.42%
HCWB
HCW Biologics
4.22
-21.66
-83.69%

BioCardia Corporate Events

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.

The most recent analyst rating on (BCDA) stock is a Buy with a $4.00 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Advances Phase 3 CardiAMP HF II Trial
Positive
May 6, 2025

On May 6, 2025, BioCardia, Inc. announced that the University of Wisconsin in Madison has begun enrolling patients with ischemic heart failure in the ongoing pivotal Phase 3 CardiAMP HF II trial. This study is evaluating the CardiAMP cell therapy product for treating patients with ischemic heart failure with reduced ejection fraction and elevated cardiac stress markers. The trial aims to confirm the safety and efficacy of the therapy, which has shown promising results in improving survival and quality of life for heart failure patients. The study’s advancements include refined treatment dose definitions and improvements to the Helix system, potentially expanding patient eligibility and treatment effectiveness.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Enrolls First Patient in Phase III Trial
Positive
May 1, 2025

On May 1, 2025, BioCardia announced the enrollment of the first patient in the Phase III CardiAMP HF II clinical trial at BayCare Morton Plant Hospital in Florida. This trial aims to confirm the safety and efficacy of its lead autologous cell therapy for heart failure, potentially impacting regulatory approvals and adoption. The trial builds on previous promising results, with advancements in patient eligibility and delivery systems, and is supported by the Maryland Stem Cell Research Fund and CMS reimbursement.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia’s CardiALLO Trial Advances After Safety Review
Positive
Apr 15, 2025

On April 15, 2025, BioCardia announced that the independent Data Safety Monitoring Board recommended the continuation of the CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial, following a positive review of the 30-day safety data. The trial, which showed no major adverse cardiac events or immune reactions, is set to progress with the enrollment of 39 participants in the United States. This development is significant for BioCardia’s MSC platform, potentially aiding discussions around funding and partnerships, and could lead to future pivotal trials and approvals in the USA and Japan.

Business Operations and Strategy
BioCardia Clarifies Timing for CardiAMP-HF Results Call
Neutral
Mar 31, 2025

On March 31, 2025, BioCardia, Inc. announced a clarification regarding the timing of its conference call to discuss the two-year CardiAMP-HF results. Initially reported to occur at 4:30pm PDT, the call was confirmed to take place at 4:30pm EDT. This announcement ensures stakeholders are informed of the correct timing to access the call, which is crucial for maintaining transparency and effective communication regarding the company’s clinical progress.

Product-Related AnnouncementsBusiness Operations and Strategy
BioCardia Reports Positive Phase 3 CardiAMP-HF Results
Positive
Mar 31, 2025

On March 31, 2025, BioCardia announced the two-year outcomes of its Phase 3 CardiAMP-HF study, revealing that its autologous cell therapy significantly improved survival, reduced major adverse cardiac and cerebrovascular events, and enhanced quality of life in ischemic heart failure patients with reduced ejection fraction. The study, involving 115 patients across 18 centers in the U.S. and Canada, showed particularly strong results in patients with elevated NTproBNP biomarkers, indicating the therapy’s potential to address a significant unmet need in heart failure treatment and reduce healthcare costs.

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: Jun 26, 2025