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SUNNYVALE, Calif. - BioCardia (NASDAQ:BCDA), Inc. [Nasdaq: BCDA], a developer of cellular therapies for cardiovascular diseases with a current market capitalization of $12 million, has announced the completion of enrollment and dosing for the low-dose cohort in its Phase I/II trial of CardiALLO™ Allogeneic Mesenchymal Cell Therapy. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though analysts anticipate sales decline in the current year. The trial targets patients with ischemic heart failure with reduced ejection fraction (HFrEF), who also show elevated markers of heart stress and systemic inflammation.
The study, which represents the first prospective trial of allogeneic mesenchymal stem cells (MSC) for treating HFrEF patients with these specific markers, aims to establish safety and efficacy for this novel cell therapy. According to Carl Pepine, M.D., the National Principal Investigator for the study, the treatment has the potential to improve the quality of life for patients who are currently limited despite existing medical therapies.
The trial involves a nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo-controlled cohort. The delivery system used for the MSC therapy is minimally invasive, entering the heart through a blood vessel. The treatment also utilizes the FDA-approved Morph DNA steerable guide to enhance precision in cell delivery.
BioCardia’s CEO, Peter Altman, Ph.D., expressed confidence in the CardiALLO MSC program, which could lead to pivotal clinical studies in the U.S. and conditional approval in Japan. The company’s manufacturing process for these cells is expected to be commercially scalable. However, InvestingPro analysis reveals the company is quickly burning through cash, with a negative free cash flow of $7.3 million in the last twelve months. For deeper insights into BioCardia’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
The therapy’s mesenchymal stem cells are believed to provide immunomodulatory benefits and promote microvascular repair. Previous trials have indicated safety and suggested efficacy for these cells, which have not required immunosuppression or produced arrhythmias.
The first independent safety review for the current trial is slated for March 2025. BioCardia’s MSC manufacturing also supports its PulmAllo™ MSC program for acute respiratory distress and may be applicable to other indications in partnership with interested parties. This follows the recent approval of the first MSC therapy in the United States.
This news article is based on a press release statement from BioCardia, Inc. The stock has shown strong momentum with a 20.6% return year-to-date, despite broader market challenges. With a current price of $2.63, InvestingPro analysis suggests the stock is trading above its Fair Value, with analyst price targets ranging from $6 to $25 per share.
In other recent news, BioCardia has announced significant progress towards the registration of its therapeutic asset, BCDA-01, in Japan for treating ischemic heart failure. The company’s CEO, Dr. Peter Altman, revealed that Japan’s Pharmaceutical (TADAWUL:2070) and Medical (TASE:PMCN) Device Agency (PMDA) is considering the results of the CardiAMP Heart Failure Trial as potential evidence for registration. Final data from this trial, which involves 125 patients, is expected to be available in the first quarter of 2025.
In addition, BioCardia has made strides in its earnings, reporting a decrease in net loss and a strengthened cash position following a public offering. The company is also expanding patient eligibility in its CardiAMP Heart Failure II trial and has received FDA approval for its Morph DNA Steerable Introducer platform.
Analysts have noted that BioCardia’s CardiAMP cell therapy has received FDA breakthrough designation and CMS reimbursement, indicating a positive outlook for the company’s developments. The company has also expressed plans to leverage regulatory advantages for launching its therapies in Japan. Despite anticipated increases in cash burn due to trial advancements and disruptions from hurricanes, BioCardia remains optimistic about its future, with a focus on achieving key objectives by the end of Q4 2024.
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