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SUNNYVALE, Calif. - BioCardia, Inc. (Nasdaq: NASDAQ:BCDA), a biotechnology firm specializing in cellular therapies for cardiovascular and pulmonary diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved a significant protocol amendment for the ongoing CardiAMP Heart Failure II Trial. This amendment will potentially allow a broader patient population to benefit from the company's CardiAMP cell therapy by enabling additional cell deliveries to reach targeted dosages.
The CardiAMP Heart Failure II Trial, which is a confirmatory Phase 3 study, is investigating the therapeutic potential of CardiAMP, an autologous cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF). The approved amendment is based on the analysis of data from the initial CardiAMP Heart Failure I Trial, which enrolled 125 patients.
Debby Holmes-Higgin, Vice President of Clinical at BioCardia, stated that this protocol modification is expected to increase the ease, efficiency, and experience for patients, physicians, and coordinators involved in the trial. The amendment stems from the development of a personalized treatment plan for patients who fall below the Cell Population Analysis acceptance criteria, which was initially designed to select patients most likely to respond to therapy.
The CardiAMP Cell Therapy has been designated as a Breakthrough Therapy by the FDA and involves delivering a patient's own bone marrow cells to the heart in a minimally invasive procedure. The therapy includes a pre-procedural cell population analysis, a high target dosage of cells, and a proprietary delivery system.
BioCardia anticipates final study results from the CardiAMP Heart Failure I Trial in November 2024, with interim results showing a 37% relative risk reduction in all-cause death. The CardiAMP Heart Failure II Trial is focusing on patients in active heart failure who showed the most significant benefits in the initial trial.
The clinical development of CardiAMP for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Center for Medicare and Medicaid Services (CMS) for both treatment and control procedures.
This news is based on a press release statement from BioCardia, Inc. and does not constitute an endorsement of the company's claims. The information presented is subject to limitations by U.S. law to investigational use and further verification.
In other recent news, BioCardia, Inc. reported its Q2 2024 financial results, revealing a decrease in net loss to $1.6 million and a 53% reduction in expenses year-over-year. The company's CardiAMP Heart Failure I trial has shown improved survival rates, fewer adverse events, and enhanced quality of life in interim results. BioCardia is also making progress with its CardiAMP Heart Failure II trial, specifically targeting patients with elevated NTproBNP levels.
BioCardia is actively discussing partnerships for its CardiAMP, CardiALLO, Helix, and Morph platforms. The company is also on track to meet NASDAQ listing requirements and is exploring funding options to avoid shareholder dilution. The FDA clearance for the Morph DNA product family is anticipated by the end of the current quarter.
Despite reporting minimal revenues of $3,000 for Q2 2024, the company's CEO, Peter Altman, expressed optimism for the end of 2024 and the outlook for 2025. The company expects a moderate increase in cash burn as clinical trials progress. These recent developments reflect BioCardia's commitment to advancing heart failure treatments and exploring growth opportunities.
InvestingPro Insights
As BioCardia, Inc. (Nasdaq: BCDA) continues to advance its CardiAMP Heart Failure II Trial, investors and stakeholders are closely monitoring the company's financial health and market performance. InvestingPro data reveals a market capitalization of $7.07 million, signaling a relatively small player in the biotechnology industry. The company has not been profitable over the last twelve months, with a reported revenue of $0.43 million and a negative gross profit margin of over -1084%. This data underscores the challenges BioCardia faces in scaling its operations and reaching profitability.
Despite these financial hurdles, the company has experienced a significant return over the last week, with a 28.57% price total return. This could reflect investor optimism following the FDA's approval of the protocol amendment for the CardiAMP trial. However, it's important to note that BioCardia's stock has taken a considerable hit over the past year, with a -74.34% price total return, indicating a volatile investment landscape.
InvestingPro Tips for BioCardia suggest that the company is quickly burning through cash and that its short-term obligations exceed its liquid assets. Additionally, analysts do not anticipate the company will be profitable this year, which is a crucial factor for potential investors to consider. For those interested in a deeper dive into BioCardia's financials and market outlook, InvestingPro offers a total of 13 tips on its platform, providing a comprehensive analysis of the company's performance and future prospects.
Investors can access these additional insights by visiting InvestingPro's dedicated BioCardia page at https://www.investing.com/pro/BCDA.
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