BioCardia, Inc. (NASDAQ: BCDA) is a clinical-stage regenerative medicine company dedicated to developing innovative cellular and cell-derived therapies for the treatment of cardiovascular and pulmonary diseases. With a focus on transforming the lives of patients suffering from these debilitating conditions, BioCardia has established itself as a leader in the field of cellular therapeutics.
Business Overview and History
BioCardia was founded in 1999 with the vision of leveraging the power of cellular therapies to address the unmet medical needs in cardiovascular care. The company's journey began with the development of its proprietary Helix™ biotherapeutic delivery system, a minimally invasive, catheter-based platform designed to precisely target the delivery of regenerative cell therapies to the heart.
In its early years, BioCardia devoted substantial resources to research and development efforts related to its therapeutic candidates and biotherapeutic delivery systems. This included conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, and protecting the company's intellectual property. To fund these activities, BioCardia raised capital primarily through the sales of equity and convertible debt securities, as well as certain government and private grants.
Over time, BioCardia made significant progress with its lead programs. The CardiAMP Cell Therapy Heart Failure Trial, a randomized, double-blinded, placebo-controlled, multi-center pivotal clinical trial for the treatment of heart failure of reduced ejection fraction, enrolled 115 patients plus a 10-patient roll-in cohort. Additionally, the company advanced its allogeneic mesenchymal stem cell therapy platform, receiving FDA approval for an investigational new drug application to deliver these cells for the treatment of ischemic heart failure with reduced ejection fraction.
Despite these advancements, BioCardia faced challenges along the way. The company had a history of operating losses and had not yet generated a profit. It also encountered regulatory hurdles, needing to regain compliance with Nasdaq's listing requirements at one point. Overcoming these obstacles required BioCardia to carefully manage its use of capital and explore various financing options, including public offerings and partnerships.
Financials
Financial Overview
BioCardia's financial performance has largely been characterized by ongoing research and development efforts, with the company prioritizing the advancement of its clinical-stage therapies. As of the latest reported quarter (Q3 2024), the company had cash and cash equivalents of approximately $4.9 million, which management believes will be sufficient to fund operations through the second quarter of 2025.
In the third quarter of 2024, BioCardia reported a net loss of $1.74 million, a significant improvement compared to the $2.57 million net loss recorded in the same period of the previous year. This reduction in net loss was primarily driven by decreases in both research and development expenses, which fell from $1.87 million to $931,000, as well as selling, general, and administrative expenses, which declined from $1.08 million to $825,000.
For the nine-month period ended September 30, 2024, BioCardia reported a net loss of $5.65 million, down from $9.50 million in the same period of 2023. The company's efforts to streamline operations and focus on its core clinical programs have contributed to this gradual improvement in financial performance.
Revenue for the third quarter of 2024 was $0, compared to $357,000 in the same quarter of 2023. This decrease was primarily due to a reduction in collaboration agreement revenue. For the full year 2023, BioCardia reported revenue of $477,000, with a net loss of $11.57 million. Operating cash flow for 2023 was negative $9.97 million, and free cash flow was negative $9.99 million.
It is worth noting that BioCardia's revenue has been modest, primarily derived from its biotherapeutic delivery partnerships and the commercialization of its Morph DNA Steerable Introducer products. The company's primary focus has been on advancing its cell therapy candidates through clinical trials, which has resulted in significant research and development expenses.
Liquidity
As mentioned earlier, BioCardia had cash and cash equivalents of approximately $4.9 million as of the end of Q3 2024. The company's management believes this will be sufficient to fund operations through the second quarter of 2025. However, BioCardia will likely need to secure additional funding to support its long-term growth and clinical milestones beyond this period.
BioCardia's debt-to-equity ratio stands at 0.38, indicating a relatively low level of debt compared to equity. The company's current ratio and quick ratio are both 1.78, suggesting that BioCardia has sufficient short-term assets to cover its short-term liabilities.
To bolster its financial position, BioCardia has access to $2.75 million in available credit through an At-The-Market (ATM) Offering Agreement with H.C. Wainwright & Co., LLC. This provides the company with additional flexibility to raise capital as needed.
Product Segments and Clinical Developments
BioCardia's product portfolio is centered around two primary segments: autologous and allogeneic cell therapy platforms.
Autologous Cell Therapy Platforms:
The CardiAMP autologous mononuclear cell therapy platform is being advanced for two cardiac indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI).
The CardiAMP Cell Therapy Heart Failure Trial, a pivotal clinical study, has completed patient follow-up for 115 advanced heart failure patients. BioCardia plans to present final data at the American College of Cardiology 2025 Scientific Sessions, with patients having a minimum of one year and a maximum of two-year follow-up. Approximately 92% of patients not lost to follow-up will have two-year results. The company intends to request a meeting with the FDA to discuss the results regarding the approvability of the CardiAMP Cell Therapy System.
Additionally, the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III study of up to 343 patients with no-option chronic myocardial ischemia and refractory angina. The open-label roll-in cohort showed promising results, with an average 107-second increase in exercise tolerance and an 82% average reduction in angina episodes at the six-month follow-up.
Allogeneic Cell Therapy Platforms:
BioCardia's CardiALLO platform, an allogeneic mesenchymal stem cell (MSC) therapy, is being developed for the treatment of ischemic HFrEF. The FDA has approved an investigational new drug application for a Phase III trial, which includes a 33-patient roll-in dose escalation cohort followed by a 60-patient randomized double-blind controlled study. The low-dose cohort of 20 million cells is expected to be completed in the fourth quarter of 2024, with no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses observed to date.
Helix Biotherapeutic Delivery System:
In addition to its cell therapy platforms, BioCardia generates revenue from its Helix biotherapeutic delivery system, a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. The company partners this delivery platform with other organizations developing biotherapeutic interventions, including a Phase III clinical study with StemCardia and a planned Phase III trial continuation with CellProthera.
Regulatory Milestones and Future Outlook
A key milestone in BioCardia's history was the FDA's granting of Breakthrough Device Designation for the CardiAMP Cell Therapy System in 2020. This designation, which is reserved for therapies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, has streamlined the company's regulatory pathway and enabled closer collaboration with the FDA.
Building on this momentum, BioCardia has made significant progress in its clinical trials. The company has initiated a confirmatory CardiAMP Heart Failure II trial, which is designed to further evaluate the efficacy of the autologous cell therapy in a larger patient population of 250 patients. Enrollment in this trial is expected to be significantly enhanced due to the positive data from the CardiAMP Heart Failure I trial.
BioCardia has outlined several key milestones to be achieved by the end of Q4 2024:
1. Consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) regarding the CardiAMP cell therapy. 2. Completion of data lock on the CardiAMP Heart Failure I trial data set. 3. Initiation of treatments and activation of three additional centers in the CardiAMP Heart Failure II trial. 4. Enrollment of the last low-dose patient in the CardiALLO Heart Failure trial. 5. Launch of the first commercial Morph DNA products and performance of initial procedures.
Additionally, BioCardia has received regulatory approvals for its Morph DNA Steerable Introducer platform, which is expected to play a crucial role in the delivery of its cell therapy candidates and potentially benefit other cardiovascular interventions. The availability of this innovative device family has the potential to enhance the company's commercial opportunities and provide a recurring revenue stream.
Competitive Landscape and Industry Trends
BioCardia operates in a highly competitive landscape, with other companies developing cellular and gene therapies for the treatment of cardiovascular diseases. Notable competitors include Mesoblast Limited, which is also pursuing allogeneic MSC therapies for heart failure, and Athersys, Inc., which is developing a stem cell-based therapy for ischemic stroke.
The regenerative medicine industry, particularly in the cardiovascular space, is experiencing strong growth, with a compound annual growth rate (CAGR) of around 15-20% expected over the next 5 years. BioCardia's focus on cell-based therapies for heart failure and other cardiovascular diseases positions it well to capitalize on this industry trend.
The success of BioCardia's therapies will depend on their ability to demonstrate superior efficacy and safety compared to standard-of-care treatments, as well as the company's ability to navigate the complex regulatory environment and secure reimbursement coverage. Additionally, the company's reliance on the continued success of its clinical trials and the timely completion of regulatory approvals poses inherent risks.
Ongoing Challenges and Future Outlook
BioCardia has faced various challenges throughout its history, including the need to secure additional funding to support its clinical development efforts. The company's cash position, while sufficient to fund operations through the second quarter of 2025, will require further capital raises to sustain its long-term growth and clinical milestones.
Despite these challenges, BioCardia remains optimistic about its future prospects. The anticipated presentation of the CardiAMP Heart Failure I trial data at the ACC 2025 Scientific Sessions, as well as the progress in its CardiALLO and Morph DNA programs, have the potential to drive increased investor interest and strategic partnerships.
Furthermore, the company's focus on developing targeted cellular therapies for cardiovascular diseases, a significant unmet medical need, positions BioCardia well to capitalize on the growing demand for regenerative medicine solutions. As the company continues to navigate the regulatory landscape and advance its clinical pipeline, it remains committed to transforming the lives of patients suffering from these debilitating conditions.
Conclusion
BioCardia's journey as a pioneer in the field of cellular therapies for cardiovascular diseases has been marked by significant progress, regulatory milestones, and the relentless pursuit of innovative solutions. With a robust pipeline, including its lead CardiAMP and CardiALLO programs, as well as the commercialization of its Morph DNA Steerable Introducer platform, the company is well-positioned to make a meaningful impact in the lives of patients and create value for its shareholders.
As BioCardia navigates the challenges and opportunities ahead, its unwavering commitment to advancing regenerative medicine remains the driving force behind its pursuit of transformative therapies. The company's focus on both autologous and allogeneic cell therapy platforms, coupled with its proprietary delivery systems, provides a diverse approach to addressing the complex needs of patients with cardiovascular diseases.
The upcoming milestones, including the presentation of final data from the CardiAMP Heart Failure I trial and the advancement of the CardiAMP Heart Failure II trial, represent critical junctures in BioCardia's development trajectory. These events have the potential to validate the company's technology and open doors to new partnerships and funding opportunities.
While financial challenges persist, BioCardia's improved net loss position and access to additional capital through its ATM offering agreement demonstrate the company's ability to manage its resources effectively. As the regenerative medicine industry continues to grow, BioCardia's strategic positioning and innovative therapies may allow it to capture a significant share of this expanding market.
In conclusion, BioCardia stands at the forefront of cellular therapies for cardiovascular diseases, with a clear vision, a robust pipeline, and a commitment to addressing significant unmet medical needs. As the company progresses through its clinical trials and regulatory milestones, it has the potential to revolutionize the treatment landscape for heart failure and other cardiovascular conditions, ultimately improving patient outcomes and quality of life.