BioCardia, Inc. (NASDAQ:BCDA) is a clinical-stage company developing innovative cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company's pipeline includes two autologous cell therapy platforms and one allogeneic cell therapy platform, all of which are currently in various stages of clinical development.
Business Overview
BioCardia is advancing two cell therapy platforms derived from the bone marrow in clinical trials today. The company's lead autologous cell therapy platform, CardiAMP®, is being evaluated for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). The company's allogeneic mesenchymal stem cell (MSC) therapy platform, CardiALLO™, is being developed as an "off the shelf" cell therapy for the treatment of ischemic HFrEF and acute respiratory distress syndrome (ARDS).The company's autologous CardiAMP and allogeneic CardiALLO cell therapies for cardiac indications are enabled by BioCardia's Helix™ minimally invasive intramyocardial therapeutic delivery platform. BioCardia also partners this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart.
Financial Overview
For the fiscal year ended December 31, 2023, BioCardia reported annual revenue of $477,000 and a net loss of $11,571,000. The company's annual operating cash flow and free cash flow were -$9,974,000 and -$9,986,000, respectively.In the first quarter of 2024, the company reported revenue of $55,000, a net loss of $2,267,000, and used $1,530,000 in cash for operating activities. The decrease in research and development expenses from $2,384,000 in Q1 2023 to $1,241,000 in Q1 2024 was primarily due to the completion of enrollment in the CardiAMP Heart Failure Trial in the second half of 2023, which led to reductions in clinical and supporting function expenses.
Liquidity and Capital Resources
As of March 31, 2024, BioCardia had cash and cash equivalents of $949,000. The company believes that its current cash and cash equivalents are not sufficient to fund its planned expenditures and meet its obligations beyond the second quarter of 2024. To continue the development of its therapeutic candidates beyond the second quarter of 2024 and to regain compliance with Nasdaq's continued listing standards, BioCardia plans to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination of these sources.Clinical Pipeline and Developments
CardiAMP Autologous Cell Therapy for Ischemic Heart Failure (BCDA-01)
The CardiAMP Heart Failure Trial is an ongoing randomized, double-blinded, controlled clinical trial in the United States with 125 patients enrolled, including a 10-patient roll-in cohort. Interim results from this study, with 110 of the 115 randomized patients, were presented in March 2024. Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes, and hospitalization due to heart failure (MACCE).In an important subgroup analysis of patients with elevated NT-proBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).
The confirmatory CardiAMP Cell Therapy Heart Failure II Trial was approved by the FDA in the fourth quarter of 2023 and is expected to have greater than 90% power to meet the primary endpoint based on the CardiAMP HF Trial interim results.
CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)
The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, controlled study of up to 343 patients at up to 40 clinical sites. Results from the open-label roll-in cohort of patients showed an average 107-second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment.CardiALLO Allogeneic MSC for Ischemic Heart Failure with HFrEF (BCDA-03)
The FDA approved the IND application for a Phase I/II trial to deliver BioCardia's allogeneic MSC for the treatment of HFrEF in December 2022. The trial includes a 3+3 roll-in dose escalation cohort followed by a 60-patient randomized double-blind controlled study. There have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response in the cohort receiving the lowest dose of 20 million cells.Helix™ Biotherapeutic Delivery System
The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. BioCardia partners this delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. In March 2024, the company announced a biotherapeutic delivery partnership with StemCardia to advance StemCardia's investigational pluripotent stem cell product candidate for the treatment of heart failure, initially through a Phase 1/2 clinical study.Risks and Challenges
BioCardia faces several risks and challenges, including the inherent uncertainties associated with developing new products and technologies, obtaining regulatory approvals, and securing adequate funding to support its ongoing operations and clinical development programs. The company's ability to continue as a going concern beyond the second quarter of 2024 will depend on its ability to raise additional capital.Outlook and Conclusion
BioCardia has made significant progress in advancing its autologous and allogeneic cell therapy platforms, as well as its biotherapeutic delivery partnerships. The positive interim results from the CardiAMP Heart Failure Trial, particularly in the subgroup of patients with elevated NT-proBNP, are highly encouraging and support the potential of the company's lead autologous cell therapy candidate. The confirmatory CardiAMP Heart Failure II Trial and the ongoing CardiAMP Chronic Myocardial Ischemia Trial also hold promise for the future.Additionally, the company's allogeneic CardiALLO program and its biotherapeutic delivery partnerships provide further avenues for growth and value creation. While BioCardia faces the challenge of securing additional funding to continue its operations and clinical development, the company's innovative therapies and delivery platform, coupled with its experienced management team, position it well to potentially address significant unmet medical needs in cardiovascular diseases and deliver value to shareholders.