Financial Data and Key Metrics Changes - Total expenses decreased by 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023, primarily driven by a 43% reduction in research and development expenses to $4.4 million from $7.7 million [35][36] - Net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023, and net cash used in operations was approximately $8 million, a 20% decrease from approximately $10 million in 2023 [37][38] - The company ended the year with cash and cash equivalents totaling $2.4 million, with expectations of a moderate increase in cash burn in 2025 [38] Business Line Data and Key Metrics Changes - The CARDI-AMP Heart Failure Trial data showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events [14][19] - Quality of life improvements were noted with a 10.5% point increase in quality of life scores and a 13.9-meter improvement in the six-minute walk distance test [14][15] Market Data and Key Metrics Changes - The market reaction to the trial results was unexpected, as the data was aligned with previous expectations despite not meeting the primary endpoint [18][19] - The company anticipates that the compelling data will enhance interest from distribution partners and strategics, particularly in the context of increasing attention on interventional therapies for heart failure [29] Company Strategy and Development Direction - The company is focused on advancing its lead therapeutic candidate, autologous cardiac cell therapy, and plans to share two-year data with regulatory authorities to align on pathways for making the therapy available [21][24] - Ongoing discussions with regulatory agencies aim to highlight the safety and efficacy of cardiac cell therapy, emphasizing the lack of long-term safety issues compared to traditional therapies [23][24] - The company is also progressing in other therapeutic programs, including the Cardi-AMP Cell Therapy and Chronic Myocardial Ischemia Trial [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strength of the two-year data and its potential impact on future trials and regulatory discussions [43][70] - The company is preparing a submission package for the PMDA in Japan, with expectations for a consultation meeting soon [78][82] - Management acknowledged the need for continued engagement with regulatory authorities to ensure a smooth approval process [81] Other Important Information - The company has completed enrollment in the low-dose cohort of its cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure [26] - The Helix biotherapeutic delivery platform is expected to enhance future commercialization and clinical development efficiency [31][32] Q&A Session Summary Question: Can you provide more details on PMDA discussions in Japan? - Management met with PMDA in November and is preparing to share two-year data, which looks promising for potential conditional approval in Japan [42][43] Question: Were there any subsequent therapies that could have impacted the data read? - All patients were on guideline-directed medical therapy, and no other medications were introduced during the trial [47][50] Question: What is the expected timeline for sharing two-year data with the FDA? - The company is compiling the data for submission and expects to have a meeting with the FDA soon, with a timeline potentially as short as three weeks [70][82] Question: How does the data from Heart Failure 1 inform Heart Failure 2 trials? - The primary endpoint structure remains the same, and the company aims to replicate the positive outcomes observed in the first trial [88] Question: What are the next steps regarding interactions with the PMDA? - The company is preparing a submission package and scheduling a consultation meeting with the PMDA, with expectations for a timeline of three to eight weeks [78][82]