Financial Data and Key Metrics Changes - In Q2 2022, the company reported revenues of approximately 2.5 million, an improvement from a net loss of 2.3 million in Q2 2022 compared to 2.4 million in Q2 2021, while SG&A expenses were unchanged at 1.2 million [19] - The company ended Q2 2022 with cash totaling 20,000 per patient procedure, retroactive to April 1, 2022, enhancing confidence among clinical partners [8] - The company is expanding its clinical trial sites, including the activation of a site in Canada, which is critical for enrollment [9][21] Company Strategy and Development Direction - The company aims to complete enrollment in the CardiAMP Heart Failure Trial by 2023 and the CardiAMP Chronic Myocardial Ischemia Trial with an interim readout [12] - The company is pursuing international partnerships for its CardiAMP Cell Therapy platform and licensing its catheter-based biotherapeutic delivery system [17] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet need in heart failure, affecting over 26 million people worldwide, and emphasized the importance of their breakthrough designation from the FDA [6][7] - The company is optimistic about its allogeneic MSC program and its potential to address local and systemic inflammation in patients recovering from acute respiratory distress [16][40] Other Important Information - The company is working on business development activities to secure non-dilutive financing and has raised $1.5 million by selling shares under its ATM facility [19][20] - The company is actively engaging with Japan's PMDA for the approval of its CardiAMP Cell Therapy, with a focus on enhancing comfort with their clinical data [13][28] Q&A Session Summary Question: When do you expect the first patient to be treated in Canada and when do you expect the other three sites to come onboard? - The first site in Canada is currently screening patients, and the other three sites are expected to come onboard soon [21] Question: What kind of results are you seeing in the U.S. regarding patient enrollment? - The company is working to enhance the ease of enrolling patients and has seen sites actively enrolling as staffing improves [23][24] Question: Can you discuss the next steps with PMDA in Japan? - The next steps involve resubmitting information in a new format and addressing feedback from the last consultation [48] Question: What is the strategy for commercialization in Japan if approved? - The company is exploring distribution deals and has engaged with potential partners in Japan [31] Question: How does the allogeneic program differentiate from other mesenchymal stem cell approaches? - The allogeneic program utilizes Neurokinin 1 receptor positive cells, which are believed to enhance therapeutic efficacy [35][36] Question: How easy or difficult will it be to enroll patients given the unpredictable trajectory of COVID-19? - The trial design allows for a smaller number of patients, and logistical challenges are manageable based on prior experience [44]
BioCardia(BCDA) - 2022 Q2 - Earnings Call Transcript