BioCardia, Inc. is a clinical-stage company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company’s innovative approach combines its proprietary CardiAMP autologous cell therapy platform and Helix minimally invasive biotherapeutic delivery system to address critical cardiovascular conditions.
Business Overview and History
BioCardia was founded in 1999 with the goal of revolutionizing the treatment of heart disease through the development of novel regenerative cell-based therapies. Since its inception, the company has devoted substantially all of its resources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems. This includes conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support, and protecting its intellectual property.
The company has funded its operations primarily through the sales of equity and convertible debt securities, as well as certain government and private grants. Despite these efforts, BioCardia has faced significant financial challenges, with net losses in each fiscal year since its inception. As of December 31, 2023, the company had an accumulated deficit of approximately $152.2 million.
BioCardia’s commercialization experience has been limited, with only a few approved or cleared products in its portfolio. These include the Morph universal deflectable guide catheters, Morph AccessPro sheaths, AVANCE steerable introducer, and Morph DNA deflectable guides. This limited commercial experience has made it challenging for the company to accurately forecast its future financial performance and growth.
Despite these challenges, BioCardia has continued to advance its clinical-stage cell-based therapies. A notable achievement is the development of its lead autologous CardiAMP cell therapy for the treatment of heart failure, which has received Breakthrough Device Designation from the FDA and is reimbursed by the Center for Medicare and Medicaid Services.
Financial Overview
BioCardia’s financial performance has been characterized by consistent net losses as the company has prioritized research and development efforts to advance its clinical-stage therapeutic candidates. In the fiscal year ended December 31, 2023, the company reported revenue of $477,000 and a net loss of $11.6 million, compared to a net loss of $11.9 million in the prior year. This was driven by research and development expenses of $7.7 million and selling, general, and administrative expenses of $4.4 million. The company’s operating cash flow for 2023 was negative $9.97 million, with a free cash flow of negative $9.99 million.
For the third quarter of 2024, BioCardia reported no revenue, compared to $357,000 in the same quarter of the previous year. The company attributed this decrease to the inconsistent nature of collaboration revenues. The net loss for Q3 2024 was $1.74 million, with operating cash flow of negative $2.61 million and free cash flow of negative $2.61 million. Expenses decreased year-over-year due to reduced personnel and clinical costs following the completion of enrollment in the CardiAMP Heart Failure Trial.
Liquidity
As of September 30, 2024, BioCardia had cash and cash equivalents of $4.93 million, which the company believes is not sufficient to fund its planned expenditures and meet its obligations beyond the second quarter of 2025. To continue the development of its therapeutic candidates, the company plans to raise additional capital through various means, including public or private equity or debt financings, government or other third-party funding, and strategic collaborations.
The company’s debt-to-equity ratio stands at 0, indicating no long-term debt on its balance sheet. BioCardia’s current ratio and quick ratio are both 1.78, suggesting a relatively healthy short-term liquidity position. However, the company has not disclosed any available credit lines.
Key Ongoing Programs and Milestones
CardiAMP Autologous Cell Therapy for Ischemic Heart Failure BioCardia’s lead program, the CardiAMP Cell Therapy Heart Failure Trial, is a randomized, double-blinded, placebo-controlled, multi-center pivotal study evaluating the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment of HFrEF. The company recently completed the last protocol-specified follow-up visit for this trial, with data expected to be released in the first quarter of 2025. The final results will be based on data that has undergone source data verification and will include an additional 13 randomized patients and patients with an additional year of follow-up outcome measures.
Additionally, BioCardia is advancing the CardiAMP Heart Failure II Trial, a confirmatory Phase III study of 250 patients at up to 40 centers that focuses on patients with the greatest potential to benefit based on the interim results of the first trial. The company recently received FDA approval for a protocol amendment that allows for a personalized treatment approach based on the patient’s own cell composition, which is expected to significantly increase the number of eligible patients. This amendment enables patients who would previously have fallen short of treatment requirements due to the nature of their cells to receive a higher dosage of cells.
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial BioCardia is also conducting a Phase III, multi-center, randomized, double-blinded, placebo-controlled study of up to 343 patients with chronic myocardial ischemia and refractory angina. An open-label roll-in cohort of these patients showed promising results, with an average 107-second increase in exercise tolerance and 82% average reduction in angina episodes at the 6-month follow-up.
CardiALLO Allogeneic MSC Therapy for Ischemic Heart Failure and ARDS BioCardia’s allogeneic MSC therapy platform, CardiALLO, is being evaluated in a Phase III trial for the treatment of ischemic HFrEF and has also received FDA approval for an investigational new drug (IND) application to study the therapy in acute respiratory distress syndrome (ARDS). The company recently completed enrollment of the low-dose cohort in the Phase I/II study and plans to advance the program further in both the United States and Japan.
Morph DNA Steerable Introducer Platform In addition to its cell therapy programs, BioCardia has also received FDA clearance for its Morph DNA Steerable Introducer product family. This platform is designed to provide a pathway for the introduction of medical instruments, such as balloon catheters and guidewires, into the peripheral and cardiac vasculature. The company is now actively engaging with potential partners and customers to drive commercialization of this enabling technology.
Future Milestones and Guidance
BioCardia expects to complete several important milestones before the end of Q4 2024, including:
The company anticipates that enrollment in the CardiAMP Heart Failure II trial will be significantly enhanced due to the positive data and experience from the CardiAMP Heart Failure I trial, as well as efforts to streamline the clinical study, implement the treatment planning approach, and leverage the experience of the broader CardiAMP clinical team.
Risks and Challenges
BioCardia’s success is heavily dependent on the continued development and potential regulatory approval of its cellular therapy candidates. Failure to achieve positive results in its ongoing pivotal trials or to obtain regulatory clearance could significantly impact the company’s future prospects. Additionally, the company’s limited commercialization experience and number of approved products make it challenging to accurately forecast its financial performance and growth.
The company’s ability to continue as a going concern is also a significant risk, as its current cash and cash equivalents may not be sufficient to fund its planned expenditures and meet its obligations beyond the second quarter of 2025. Failure to raise additional capital could force BioCardia to reduce operating expenses, delay or reduce the scope of its product development programs, or even cease operations.
Conclusion
BioCardia is a pioneering company in the field of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. The company’s innovative approach, which combines its proprietary CardiAMP autologous cell therapy and Helix minimally invasive delivery system, has the potential to address significant unmet medical needs in the treatment of heart failure and other critical cardiovascular conditions.
Despite the company’s financial challenges and the inherent risks associated with the development of novel therapies, BioCardia’s progress in its ongoing pivotal trials and the recent FDA clearance of its Morph DNA Steerable Introducer platform provide reasons for cautious optimism. The company’s focus on advancing its cell therapy programs through clinical development, coupled with its efforts to generate revenue from its Helix and Morph DNA platforms through partnerships, demonstrates a strategic approach to growth and commercialization.
As BioCardia continues to execute its strategic plan and potentially secure additional funding, its ability to bring its transformative therapies to market could have a profound impact on the lives of patients suffering from these debilitating diseases. The upcoming milestones and data readouts in the near future will be crucial in determining the company’s trajectory and potential for success in the competitive landscape of regenerative medicine.
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