BioCardia(US:BCDA)2022-03-29 23:53Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2021, totaled just over $1 million, compared to $145,000 for the year ended December 31, 2020, representing an increase of approximately 7-fold [17] - The net loss for 2021 was $12.6 million, compared to a net loss of $15 million in 2020, indicating a reduction in losses [18] - Net cash used in operating activities in 2021 was $10.4 million, down from $12.4 million in 2020, reflecting a decrease in overall spending for operations of approximately $2 million [18] - The company ended 2021 with just under $13 million in cash and equivalents, which is anticipated to be sufficient for planned activities in 2022 [18] Business Line Data and Key Metrics Changes - The CardiAMP autologous cell therapy pivotal clinical trials received FDA breakthrough designation, which is expected to enhance the credibility and attractiveness of the therapy [8][9] - The company has initiated discussions with Japan's Pharmaceutical and Medical Device Agency regarding the registration of CardiAMP Cell Therapy based on existing clinical data [14] Market Data and Key Metrics Changes - The company is targeting to complete enrollment in the heart failure trial and the chronic myocardial ischemia trial by 2023, indicating a strategic focus on accelerating clinical programs [20][55] Company Strategy and Development Direction - The company aims to significantly accelerate both autologous CardiAMP Cell Therapy clinical programs and grow partnering and commercial product revenues in 2022 [20] - The company is actively seeking partnerships for CardiAMP outside the United States, particularly in Japan, to address the unmet need for heart failure therapies [57] - The company is also focused on monetizing assets that do not fit core initiatives, such as the AVANCE transseptal sheet, to support other initiatives [59] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the waning impact of COVID-19 on clinical trial enrollment and highlighted efforts to reduce barriers for patient enrollment [25][38] - The management noted that the FDA's recognition of the CardiAMP Cell Therapy as a breakthrough therapy enhances physician and patient comfort, which is expected to facilitate trial progress [25][26] Other Important Information - The company completed the transition of its laboratories and manufacturing to a new facility in Sunnyvale, which is designed to accommodate clinical and commercial manufacturing needs [19] - The company has received a new CMS reimbursement code to support both treatment and control arms of the CardiAMP Cell Therapy procedures [12] Q&A Session Summary Question: When will patient recruitment start in Canada and what is the enrollment pace in the U.S.? - Management expects to activate all four sites in Canada within a handful of weeks and anticipates a more rapid enrollment pace in the U.S. due to recent regulatory support [24][25] Question: How many patients did not access the trial due to lack of insurance coverage? - Management estimates that approximately 50% of patients are Medicare patients, and efforts are being made to address insurance coverage issues to enhance enrollment [31][32] Question: What are the expectations for the next DSMB review? - The next DSMB review is scheduled for the cusp of August-September, and management is hopeful for increased enrollment following this review [28] Question: What are the critical measures associated with the trial's endpoint? - The trial uses the Finkelstein-Schoenfeld hierarchical analysis, which includes mortality, major adverse cardiac events, and functional capacity as measured by the 6-minute walk [61][62]