Financial Data and Key Metrics Changes - Total expenses increased by $396,000 quarter over quarter to $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [15] - Research and development expenses rose by $289,000 to $1,500,000 in Q1 2025 from $1,200,000 in Q1 2024 [15] - Net loss was $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [16] - Net cash used in operations was $1,600,000 for Q1 2025, comparable to $1,500,000 in Q1 2024 [17] Business Line Data and Key Metrics Changes - The CARDI Amp heart failure trial demonstrated safety and meaningful benefits for heart failure patients [6] - The CardioM Heart Failure II trial is actively enrolling patients at three clinical sites, with expectations for full enrollment over the next two years [7] - The Helix biotherapeutics delivery system is preparing for submission for approval, with potential value for therapeutic partners [9] Market Data and Key Metrics Changes - The electrophysiology market is valued at over $10 billion per year and is expanding to treat arrhythmias in the ventricles of the heart [12] - The company is focused on the Japanese market, with expectations for regulatory approval processes similar to the FDA [30] Company Strategy and Development Direction - The company aims to align with the FDA and Japan's PMDA to make CARDI Amp therapy available to physicians and patients [6] - Business development efforts are focused on partnerships that enhance shareholder value across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA [10] - The company is open to partnerships in various indications not currently pursued, particularly in the allogeneic cell therapy space [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their therapies, emphasizing the importance of generating additional clinical evidence [40] - The company is optimistic about the potential for significant market opportunities in Japan, particularly with the CARDI Amp therapy [35] - Management noted that they are not significantly impacted by tariffs due to the domestic manufacturing of most components [49] Other Important Information - The company completed a small financing with minimal dilution to support upcoming milestones [14] - Management highlighted the importance of physician outreach and training for the introduction of new therapies into commercial channels [32] Q&A Session Summary Question: Discussion on business development maturity levels - Management indicated that while deal discussions can be lengthy, they have established products and ongoing discussions with large strategic partners [20] Question: Importance of Japan PMDA submission for CARDI Amp - Management confirmed that receiving permission to submit for approval in Japan is critical and aligns with their strategy for market entry [30] Question: Interaction between ongoing trials and FDA submission - Management clarified that they are continuously developing evidence while submitting for FDA approval, focusing on patient enrollment and data generation [40]

Financial Data and Key Metrics Changes - Total expenses increased by $396,000 quarter over quarter to $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [14] - Research and development expenses rose by $289,000 to $1,500,000 in Q1 2025 from $1,200,000 in Q1 2024, driven by costs related to the cardiac heart failure trial [15] - Net loss was $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [16] Business Line Data and Key Metrics Changes - The CARDI Amp heart failure trial results showed safety and meaningful benefits for heart failure patients, with a focus on sharing data with regulatory agencies [5] - The CardioM Heart Failure II trial is actively enrolling patients at three clinical sites, with expectations for full enrollment over the next two years [6] - The Helix biotherapeutics delivery system is preparing for submission for approval, with potential value for therapeutic partners [7] Market Data and Key Metrics Changes - The electrophysiology market, valued at over $10 billion annually, is expanding to treat arrhythmias in the ventricles of the heart, where the company delivers cell therapies [11] - The company is focused on the Japanese market, with ongoing discussions with regulators and potential distributors for the CARDI Amp cell therapy [25] Company Strategy and Development Direction - The company aims to align with the FDA and Japan's PMDA to make the CARDI Amp therapy available to physicians and patients [5] - The strategy includes enhancing partnerships across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA, to create value for shareholders [10] - The company is focused on minimizing operational costs and enhancing enrollment through partnerships and innovative delivery systems [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval process in Japan, anticipating a six-month timeframe for clarity on submission [30] - The company believes that its extensive clinical data will help close the valuation gap with peers in Japan [33] - Management highlighted the importance of ongoing clinical trials to develop further evidence for their therapies [38] Other Important Information - The company completed a small financing with minimal dilution to support upcoming milestones [13] - The company maintains a low burn rate, providing flexibility in funding value creation [16] Q&A Session Summary Question: Discussion on business development maturity - Management emphasized the importance of established products and ongoing discussions with large strategic partners [20] Question: Importance of Japan's PMDA submission - Management confirmed that PMDA's acceptance for submission is akin to FDA's acceptance of a BLA, which is critical for market entry [28] Question: Interaction between ongoing trials and FDA submission - Management clarified that they are developing additional evidence while submitting for FDA approval, focusing on patient enrollment and trial design improvements [39]