Executive Summary / Key Takeaways

• BioCardia is advancing targeted cellular therapies for cardiovascular diseases, leveraging its proprietary Helix delivery system and focusing on the high-need ischemic heart failure market.
• Recent 2-year data from the CardiAMP Heart Failure I trial, while not meeting the primary endpoint across the full cohort, demonstrated statistically significant benefits (p=0.02) in survival, cardiac events, and quality of life in the key subset of patients with elevated heart stress biomarkers (NTproBNP).
• The company is strategically focused on the CardiAMP Heart Failure II pivotal trial, designed to confirm these positive results in the responsive NTproBNP patient population, incorporating protocol enhancements expected to significantly boost enrollment.
• Despite promising clinical data and technological differentiation, BioCardia faces significant liquidity challenges, with current cash insufficient to fund operations beyond July 2025, raising substantial doubt about its ability to continue as a going concern and requiring near-term capital raises.
• Key catalysts include ongoing regulatory consultations with the FDA and Japan's PMDA for potential CardiAMP approval, progress in the CardiAMP HF II and other pipeline trials, and potential business development deals leveraging its technology platforms.

The Unmet Need and BioCardia's Targeted Approach

BioCardia, Inc. is a clinical-stage biotechnology company dedicated to developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases. At its core, the company's strategy revolves around addressing significant unmet medical needs, particularly in ischemic heart failure with reduced ejection fraction (HFrEF), a condition affecting approximately 1 million Americans with a high annual mortality rate. BioCardia's approach is rooted in precision medicine, utilizing targeted cellular therapies delivered locally to damaged heart tissue, guided by patient-specific biomarkers.

The company's pipeline is built upon two primary therapeutic platforms: the CardiAMP autologous mononuclear cell therapy, derived from a patient's own bone marrow, and the CardiALLO allogeneic mesenchymal stem cell (MSC) therapy, an "off-the-shelf" option. These therapies are designed to stimulate the body's natural healing response, aiming to promote microvascular repair, increase capillary density, and reduce fibrosis in the heart.

Crucially, BioCardia's therapeutic delivery is enabled by its proprietary Helix transendocardial biotherapeutic delivery system. This minimally invasive, catheter-based platform is designed for targeted delivery of biologic agents directly into the heart muscle. The Helix system is a key technological differentiator, empowering a seamless transition from research to potential commercialization for both BioCardia's internal programs and potential partners. Its design features, including stability in the beating heart and a self-sealing helical pathway into the tissue, are cited by management as contributing to a "threefold efficiency of delivery" and "enhanced pharmacokinetics," resulting in approximately 18-fold better cell retention compared to traditional intracoronary delivery methods. This technical advantage is believed to be fundamental to the positive signals observed in BioCardia's clinical trials.

Complementing the Helix system is the Morph DNA steerable introducer platform. While an element of the Helix system, Morph DNA is also being pursued as a standalone commercial product. This platform, which received FDA market clearance for a broader product family in August 2024, features a unique rotating tendon element designed to enable deflection rotation and substantially reduce "catheter whip." This provides enhanced physician control, particularly advantageous in navigating the tortuous regions of the heart's ventricles, where BioCardia delivers its cell therapies. The Morph DNA platform is now "open for business in a competitive, but real market," including the large cardiac electrophysiology market. BioCardia is exploring potential distribution or even divestiture of this platform to generate non-dilutive capital, while crucially retaining exclusive rights for its use in biotherapeutic intervention.

Competitive Positioning in a Dynamic Landscape

BioCardia operates within the competitive landscape of regenerative medicine and cardiovascular therapeutics. Direct competitors include companies like Mesoblast (MESO), Vericel (VCEL), and United Therapeutics (UTHR), which are also developing cell-based or advanced therapies for cardiovascular conditions.

Compared to larger, more diversified players like United Therapeutics, BioCardia maintains a niche focus on cardiac-specific cell therapies and delivery systems. While companies like Mesoblast focus on allogeneic therapies with scalable manufacturing, BioCardia's CardiAMP program leverages an autologous approach, avoiding the need for immunosuppression. BioCardia's proprietary Helix delivery system provides a distinct technological moat, enabling more precise and efficient delivery compared to alternative methods, including the open-chest surgical procedures used by some competitors in Japan (e.g., Heartseed and Cuorips, who are pursuing approval based on significantly smaller patient cohorts of 10 and 8 patients, respectively, compared to BioCardia's approximately 200 patients treated across its CardiAMP trials). This minimally invasive approach and larger clinical dataset are key differentiators in regulatory discussions, particularly in markets like Japan where BioCardia is actively pursuing approval pathways.

Financially, BioCardia is at an earlier stage of commercialization compared to companies like Vericel, which has established product sales. BioCardia's revenue is currently modest, primarily derived from biotherapeutic delivery partnering agreements, and has shown significant variation ($0 in Q1 2025 vs. $55k in Q1 2024). The company has consistently incurred net losses and negative operating cash flows as it invests heavily in R&D. In contrast, competitors like Vericel and United Therapeutics demonstrate positive operating margins and cash flow generation, reflecting their more advanced commercial status. BioCardia's high R&D investment relative to its current revenue reflects its clinical-stage focus but also contributes to its cash burn and financial vulnerability compared to better-capitalized peers.

The Morph DNA platform enters a competitive market for steerable introducers, but its technical features are highlighted as providing potential advantages in physician control. BioCardia's strategy to potentially divest this asset aims to leverage its value to fund the core therapeutic pipeline, a strategic move to enhance its financial position relative to competitors without diluting focus from its primary therapeutic goals.

The CardiAMP Story: Data Signals and the Path Forward

The core of BioCardia's investment thesis currently rests on the CardiAMP autologous cell therapy program, particularly for ischemic heart failure. The recently reported 2-year results from the CardiAMP Heart Failure I trial (115 randomized patients) are pivotal. While the trial did not meet its primary composite endpoint across the entire study population, analysis revealed compelling signals of benefit.

Specifically, in the pre-specified subset of patients with elevated NTproBNP (a biomarker indicating active heart stress), CardiAMP cell therapy demonstrated a statistically significant improvement (p=0.02) in a composite outcome measure that included survival, major adverse cardiac and cerebrovascular events (MACCE), and quality of life (measured by the Minnesota Living with Heart Failure Questionnaire). Within this responsive subgroup, results showed a 47% relative risk reduction in heart death equivalents, a 16% relative risk reduction in non-fatal MACCE, and a clinically meaningful 10.5-point improvement in quality of life score at two years. Management emphasizes that these benefits were observed across all three tiers of the composite endpoint in this subgroup, a robust signal in a patient population with significant unmet need where existing therapies often have limited impact on mortality. Furthermore, the therapy showed strong trends toward reducing cardiac arrhythmias, a valuable safety signal.

Building directly on these findings, BioCardia is now advancing the CardiAMP Heart Failure II trial. This 250-patient randomized pivotal study is specifically designed to confirm the safety and efficacy results observed in the elevated NTproBNP subset from the HF I trial. Management is highly optimistic about the statistical probability of success for HF II, citing over 90% power based on the HF I interim data in this target population.

Enrollment in CardiAMP Heart Failure II has commenced, with the first patient enrolled in April 2025 and three sites currently active. The company is implementing several strategic enhancements to accelerate enrollment compared to the first trial. These include leveraging the compelling HF I data to motivate investigators and patients, streamlining the trial design (e.g., allowing phone follow-ups for certain visits to reduce site burden), and crucially, incorporating an FDA-approved protocol amendment for personalized treatment planning. This amendment utilizes a pre-procedure cell population analysis to tailor dosing, expected to significantly increase patient eligibility by reducing the exclusion rate from approximately 35% down to about 15%. Patients whose cells fall below a certain threshold but above 65% of the target will receive 15 deliveries instead of the standard 10, aiming to ensure optimal dosing. The trial also benefits from Medicare coverage ($17,000 per procedure), which substantially reduces the company's direct costs for enrollment. Management expects the trial to be fully enrolled over the next two years, with a primary readout one year after the last patient reaches their follow-up endpoint.

Beyond heart failure, BioCardia is also advancing the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (BCDA-02), a Phase 3 study for refractory angina. Results from the open-label roll-in cohort showed encouraging improvements at six months, including an average 107-second increase in exercise tolerance and an 82% average reduction in angina episodes. The company intends to deliver topline data from this cohort soon.

The CardiALLO allogeneic MSC program (BCDA-03) is also progressing, with the low-dose cohort of its Phase I/II trial in ischemic HFrEF recently completed. A Data Safety Monitoring Board review based on 30-day safety data recommended proceeding, with no treatment-emergent adverse events reported, a positive signal for this off-the-shelf therapy. The company plans to complete the next dosing cohort and anticipates advancing Phase 2 development in both the United States and Japan within approximately one year. BioCardia believes its manufacturing cost profile for these cells is competitive, potentially less than peers.

Financial Health and the Path to Sustainability

BioCardia's financial position reflects its status as a clinical-stage biotechnology company with significant R&D expenditures and limited revenue generation. The company has incurred net losses and negative cash flows from operations since its inception, resulting in an accumulated deficit of approximately $162.8 million as of March 31, 2025.

In the first quarter of 2025, the company reported $0 in collaboration revenue, compared to $55,000 in the same period of 2024. Research and development expenses increased to $1.5 million in Q1 2025 from $1.2 million in Q1 2024, primarily driven by closeout activities for the CardiAMP HF I trial and the initiation of enrollment in HF II. Selling, general, and administrative expenses saw a modest increase to $1.2 million from $1.1 million year-over-year. The net loss for Q1 2025 was $2.7 million, compared to $2.3 million for Q1 2024. Net cash used in operating activities was $1.6 million in Q1 2025, comparable to $1.5 million in Q1 2024.

As of March 31, 2025, BioCardia held cash and cash equivalents of $949,000. While the company subsequently raised additional capital through a private placement ($775,000 gross proceeds on April 22, 2025) and ATM sales ($234,000 gross proceeds between April 1 and May 13, 2025), management explicitly states that based on its current operating plan, these funds are not sufficient to fund planned expenditures and meet obligations beyond July 2025. This situation raises substantial doubt about the company's ability to continue as a going concern within one year from the filing date of the Q1 2025 report (May 14, 2025).

The need for additional funding is paramount for BioCardia to continue the development of its therapeutic candidates. The company plans to raise capital through various means, including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination. However, management acknowledges that these plans are not entirely within their control and cannot be assessed as probable of occurring. Failure to secure adequate funding could necessitate reducing expenses, delaying or curtailing development programs, relinquishing rights to technologies, or potentially ceasing operations. Raising funds through equity or convertible debt would likely result in significant dilution for existing shareholders.

Adding to the financial challenges, BioCardia received notice in April 2025 that it is not in compliance with the Nasdaq minimum stockholders equity requirement ($837,000 as of December 31, 2024, versus the $2.5 million requirement). The company is required to submit a plan to regain compliance by May 16, 2025. Failure to regain compliance could lead to delisting, negatively impacting the stock's liquidity and the company's ability to raise future capital.

Management anticipates a moderate increase in overall cash burn and R&D expenses in 2025 as the CardiAMP HF II trial ramps up and other programs advance. SG&A expenses are expected to remain relatively stable. The company emphasizes its commitment to carefully managing capital, but the current financial runway is short, making successful capital raising a critical near-term priority.

Outlook and Strategic Catalysts

Despite the significant financial risks, BioCardia's outlook is tied to the successful execution of its clinical programs and business development strategy. The positive signals from the CardiAMP HF I trial, particularly in the target NTproBNP population, provide a foundation for the pivotal HF II study, which is strategically designed with a high probability of success based on prior data. The strategic enhancements to HF II enrollment are expected to accelerate progress towards the anticipated 2-year enrollment timeline.

A key near-term catalyst is the submission of the CardiAMP HF I 2-year data and subsequent consultations with the FDA and Japan's PMDA. Management is hopeful that these discussions will lead to clarity on potential approval pathways, potentially within approximately six months for the PMDA regarding submission eligibility. Approval in Japan, where the therapy would be regulated as a device system and potentially receive full approval based on the existing data, is viewed as a significant opportunity that could enhance the company's valuation relative to Japanese peers.

Business development remains a central pillar of the strategy, with active discussions ongoing across all four platforms. The HF I data is expected to bolster interest in CardiAMP partnerships. The Helix system's demonstrated delivery advantages and the Morph DNA platform's FDA clearance offer distinct assets for potential collaboration or divestiture, aiming to generate non-dilutive funding. Peer successes in the allogeneic cell therapy space may also enhance partnering prospects for CardiALLO.

Management's guidance points to continued operational losses and a need for substantial external funding in the very near term. The ability to successfully raise this capital and regain Nasdaq compliance are critical factors that will determine the company's ability to execute on its clinical and strategic objectives.

Conclusion

BioCardia stands at a critical juncture, armed with promising clinical data from its lead CardiAMP Heart Failure program and differentiated technology platforms in a high-need therapeutic area. The statistically significant benefits observed in the target patient population of the CardiAMP HF I trial provide a compelling rationale for the ongoing pivotal HF II study, which is strategically designed for enhanced enrollment and a high probability of success. The proprietary Helix delivery system and FDA-cleared Morph DNA platform offer valuable assets for both internal development and potential partnerships, representing key competitive advantages.

However, the company faces an immediate and significant challenge regarding its liquidity, with current cash resources projected to be insufficient to fund operations beyond July 2025. Addressing this funding gap and regaining compliance with Nasdaq listing requirements are paramount near-term priorities. The investment thesis hinges on BioCardia's ability to successfully navigate these financial hurdles while simultaneously advancing its clinical pipeline and securing strategic partnerships. The outcome of regulatory consultations, the pace of enrollment in HF II, and progress in business development discussions will be crucial indicators to watch as BioCardia seeks to translate its technological innovation and clinical data into sustainable value for shareholders.