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BioCardia Inc (BCDA)
NASDAQ:BCDA

BioCardia (BCDA) AI Stock Analysis

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BioCardia

(NASDAQ:BCDA)

34Underperform
BioCardia faces significant financial challenges and technical weaknesses, reflected in its low stock score. While recent trial successes and regulatory progress offer some positive prospects, financial instability and market uncertainty weigh heavily on the company's outlook.
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 Launch
Morph DNA Introducer now commercially available, providing new revenue stream.
Negative Factors
Clinical Trial Challenges
The DSMB determined that the study would not meet the primary Finkelstein Schoenfeld composite endpoint and recommended to pause enrollment.
Clinical Trial Setback
DSMB determined that the study would not meet the primary Finkelstein Schoenfeld composite endpoint and recommended to pause enrollment.

BioCardia (BCDA) vs. S&P 500 (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 primarily makes money through the development and commercialization of its proprietary cell therapy systems. The company's revenue model is largely centered around clinical trials and collaborations with medical institutions for the advancement of its CardiAMP and CardiALLO systems. Revenue streams may include licensing agreements, sales of therapy systems, and milestone payments from partnerships with healthcare organizations and research institutions. BioCardia's earnings are significantly influenced by the successful progression of clinical trials, regulatory approvals, and the subsequent commercialization of its therapeutic products.

BioCardia Financial Statement Overview

Summary
BioCardia's financial performance is weak, with negative EBIT, net income margins, and volatile revenue. The balance sheet shows high leverage risks and stagnant asset growth, while cash flow relies heavily on financing. Overall, the company faces financial instability and challenges in achieving profitability.
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.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
58.00K477.00K1.35M1.01M145.00K
Gross Profit
58.00K-7.25M-10.55M375.00K141.00K
EBIT
-8.00M-11.64M-11.90M-12.63M-15.53M
EBITDA
-7.93M-11.56M-11.82M-12.57M-14.44M
Net Income Common Stockholders
-7.95M-11.57M-11.91M-12.62M-15.01M
Balance SheetCash, Cash Equivalents and Short-Term Investments
2.37M1.10M7.36M12.87M21.41M
Total Assets
3.72M2.99M9.79M15.72M23.42M
Total Debt
951.00K1.31M1.63M1.87M614.00K
Net Debt
-1.42M212.00K-5.73M-11.00M-20.79M
Total Liabilities
2.89M4.59M4.90M5.34M4.25M
Stockholders Equity
837.00K-1.60M4.89M10.38M19.18M
Cash FlowFree Cash Flow
-8.03M-9.99M-10.63M-10.48M-12.39M
Operating Cash Flow
-8.03M-9.97M-10.56M-10.37M-12.36M
Investing Cash Flow
-6.00K-12.00K-70.00K-116.00K-32.00K
Financing Cash Flow
9.30M3.73M5.12M1.95M28.21M

BioCardia Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.82
Price Trends
50DMA
2.33
Negative
100DMA
2.28
Negative
200DMA
2.49
Negative
Market Momentum
MACD
-0.16
Positive
RSI
36.94
Neutral
STOCH
25.17
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 1.82 is below the 20-day moving average (MA) of 2.07, below the 50-day MA of 2.33, and below the 200-day MA of 2.49, indicating a bearish trend. The MACD of -0.16 indicates Positive momentum. The RSI at 36.94 is Neutral, neither overbought nor oversold. The STOCH value of 25.17 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 70 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
$5.31B3.33-39.82%2.92%17.95%1.84%
51
Neutral
$12.68M-96.89%175.03%55.34%
38
Underperform
$7.68M-52.85%8.99%
38
Underperform
$8.73M-58.40%1.00%
36
Underperform
$8.94M-897.37%-9.68%-13.26%
34
Underperform
$8.24M-737.89%-87.84%59.34%
34
Underperform
$15.93M-141.94%64.01%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BCDA
BioCardia
1.82
-3.70
-67.03%
LPTX
Leap Therapeutics
0.39
-2.78
-87.70%
CTXR
Citius Pharmaceuticals
0.87
-17.44
-95.25%
BRTX
BioRestorative Therapies
1.69
0.46
37.40%
SNSE
Sensei Biotherapeutics
0.38
-0.62
-62.00%
HCWB
HCW Biologics
7.94
-50.46
-86.40%

BioCardia Earnings Call Summary

Earnings Call Date: Mar 26, 2025 | % Change Since: -28.63% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Positive
The earnings call presented a strong set of trial results with significant reductions in heart failure risks and improvements in quality of life. Financial management showed positive trends with reduced expenses and losses. Despite not meeting the primary endpoint, the data was compelling enough to support ongoing regulatory discussions and future trials. However, the unexpected negative market reaction was a noted concern.
Highlights
Strong CardiAMP Heart Failure Trial Results
The CardiAMP Heart Failure trial showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events. Quality of life scores improved by 10.5 points, and there was a 13.9-meter improvement in the 6-minute walk distance. The trial also demonstrated improved left ventricular ejection fraction, reduced heart volumes, and reduced cardiac arrhythmias.
Financial Improvements
BioCardia's total expenses decreased by 35% year-over-year to $8.1 million in 2024, driven by a 43% reduction in research and development expenses. The net loss decreased from $11.6 million in 2023 to $7.9 million in 2024.
Regulatory Progress and Future Developments
The CardiAMP cell therapy has an FDA breakthrough designation and discussions with regulatory agencies in the US and Japan are ongoing. The CardiAMP Heart Failure II trial is active with potential for regulatory approval based on the strong data.
Lowlights
Primary Endpoint Not Met
The CardiAMP Heart Failure trial did not meet its primary endpoint due to the 6-minute walk test distance in healthier patients without elevated markers of heart stress.
Surprise Market Reaction
Despite strong data, the market reaction was unexpectedly negative, which was surprising to the management.
Company Guidance
During the BioCardia Year-End 2024 Financial Results and Business Update Conference Call, the company provided several key metrics regarding their ongoing clinical trials and financial status. BioCardia announced the results of the CardiAMP Heart Failure trial, which involved 115 randomized ischemic heart failure patients treated with their lead therapeutic candidate, CardiAMP Cell Therapy (BCD-01). The trial showed a 47% relative risk reduction in cardiac death equivalents, a 16% relative risk reduction in major adverse cardiac events, a 10.5-point improvement in quality of life score, and a 13.9-meter improvement in the 6-minute walk distance test over a 2-year follow-up period. Although the primary endpoint was not met, significant improvements were observed, especially in patients with elevated NTproBNP, achieving a p-value of 0.02 for quality of life. Financially, BioCardia reported a 35% decrease in total expenses to $8.1 million for 2024, with a net loss of $7.9 million and cash and cash equivalents totaling $2.4 million at year-end. The company anticipates modest increases in R&D expenses for 2025 as they advance their therapeutic candidates.

BioCardia Corporate Events

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.

Spark’s Take on BCDA Stock

According to Spark, TipRanks’ AI Analyst, BCDA is a Underperform.

BioCardia faces significant financial challenges, with ongoing losses and high volatility in revenue growth. While technical indicators suggest a potential rebound, the company’s valuation remains unattractive due to negative earnings. Positive trial results and financial improvements from the earnings call provide some optimism, but the failure to meet primary endpoints and unexpected market reactions highlight ongoing risks.

To see Spark’s full report on BCDA stock, click here.

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
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.