Capricor Therapeutics(CAPR) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of September 30, 2021, the company's cash and cash equivalents totaled approximately $40.8 million, compared to approximately $32.7 million on December 31, 2020, indicating a positive cash flow situation [40] - For the first nine months of 2021, the net cash used in operating activities was approximately $11.2 million, with a net loss of approximately $13.8 million compared to a net loss of approximately $9.5 million for the same period in 2020 [41][42] Business Line Data and Key Metrics Changes - The research and development expense for Q3 2021, excluding stock-based compensation, was approximately $2.4 million, a decrease from approximately $2.6 million in Q3 2020 [41] - General and administrative expenses for Q3 2021, excluding stock-based compensation, were approximately $1.1 million, compared to approximately $900,000 in Q3 2020, indicating an increase in administrative costs [42] Market Data and Key Metrics Changes - The company is focused on two main pipeline programs: CAP-1002 for Duchenne muscular dystrophy (DMD) and severe COVID-19, and an emerging platform technology involving exosomes as drug delivery vehicles [5][22] Company Strategy and Development Direction - The company is committed to advancing CAP-1002 for DMD and has received FDA clearance to proceed with the HOPE-3 trial, aiming to enroll approximately 70 patients [10][11] - The company is also developing an exosome platform technology for drug delivery, which is seen as a cornerstone for future vaccine development and other therapeutic applications [26][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the data from the HOPE-2 trial and is actively working on initiating the HOPE-3 study [44] - The company is in a strong position regarding manufacturing readiness and supply chain management, indicating no expected issues for the upcoming studies [45][46] Other Important Information - The company has secured important regulatory designations, including RMATs for CAP-1002, and is working closely with the FDA to ensure commercial supply readiness [11][46] - The company has relocated its R&D headquarters to San Diego, California, and has assembled a strong team to advance its exosome platform [35] Q&A Session Summary Question: Update on HOPE-3 study and potential partnership - Management is encouraged by HOPE-2 data and is developing plans to initiate HOPE-3, with a focus on enrolling patients [44] Question: Manufacturing readiness and supply chain impacts - Management confirmed that they are well-prepared for manufacturing and do not anticipate issues related to global supply chain challenges [45] Question: Next steps pending INSPIRE trial data - Management will evaluate next steps based on the data from the INSPIRE trial and will keep stakeholders updated [47] Question: Visibility on exosome platform development - Management indicated that they have several targets in development and will provide updates on the exosome platform in early 2022 [49]