SUNNYVALE, Calif. - BioCardia, Inc. (NASDAQ:BCDA), a biotechnology firm specializing in cardiovascular treatments, has released interim results from a Phase III trial of its CardiAMP autologous cell therapy, indicating a reduction in heart failure-related health risks.
The study, which followed 110 patients with advanced chronic heart failure over an average of 20 months, found a 37% relative risk reduction in heart death equivalents and a 9% reduction in major adverse cardiac and cerebrovascular events (MACCE) for those treated with CardiAMP compared to control patients on standard heart medications.
The findings, presented at the Technology and Heart Failure Therapeutics annual meeting, also highlighted a subgroup of patients with elevated NTproBNP levels, a biomarker for heart distress. This subgroup, constituting 59% of the participants, experienced an 86% relative risk reduction in heart death equivalents and a 24% reduction in non-fatal MACCE.
Despite not meeting the composite primary endpoint, which included a six-minute walk distance, the results have prompted the FDA's approval of a follow-on Phase III trial, CardiAMP HF II, focusing on the high-responding patient population with elevated NTproBNP. The trial is expected to validate the positive interim results and potentially improve outcomes for patients with advanced chronic heart failure.
BioCardia CEO Peter Altman expressed optimism about the trial's outcomes and their consistency in the final 24-month data analysis. The company also reported the initiation of a Phase I/II study of CardiALLO allogeneic mesenchymal stem cell therapy in heart failure patients, with no adverse events noted in the cohort receiving the lowest dose.
The trial's positive interim results are based on a press release statement from BioCardia, Inc.
InvestingPro Insights
In the wake of the promising trial results for BioCardia's CardiAMP therapy, the company's financial health and market performance provide additional context for investors. According to real-time data from InvestingPro, BioCardia has a market capitalization of $12.59 million, reflecting its status as a small-cap biotechnology firm. Despite the clinical advancements, the company faces financial challenges, with a negative price-to-earnings (P/E) ratio of -0.71 and a substantial decline in revenue growth of -56.98% over the last twelve months as of Q3 2023. This indicates that while the company is advancing in its clinical trials, it is not currently generating profits or growing its revenue.
InvestingPro Tips highlight several critical aspects for potential investors. BioCardia is quickly burning through cash, which is a concern for its financial sustainability. Moreover, analysts do not anticipate the company will be profitable this year, and significant short-term obligations exceed the company's liquid assets. These factors are essential considerations for investors, especially given the company's significant return over the last week and month, with price total returns of 26.04% and 35.82% respectively. However, the price has fallen significantly over the last year, with a -74.23% return, suggesting volatility and uncertainty in the stock's performance.
For those interested in a deeper analysis, InvestingPro offers additional insights, including a comprehensive list of 13 InvestingPro Tips for BioCardia. Investors can explore these tips to gain a more nuanced understanding of the company's financial health and market potential. To access these insights and benefit from the full range of features, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
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