Capricor Therapeutics(CAPR) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of March 31, 2023, the company's cash, cash equivalents, and marketable securities totaled approximately $45.2 million, an increase from approximately$41.4 million on December 31, 2022 [26] - The net cash provided by operating activities for Q1 2023 was approximately $4.2 million, while the net loss for both Q1 2023 and Q1 2022 was approximately$7.8 million [27][28] Business Line Data and Key Metrics Changes - Research and development expenses, excluding stock-based compensation, were approximately $7.2 million in Q1 2023, compared to approximately$4.9 million in Q1 2022 [27] - General and administrative expenses, excluding stock-based compensation, were approximately $1.8 million in Q1 2023, slightly down from approximately$1.9 million in Q1 2022 [27] Market Data and Key Metrics Changes - The company is focused on securing partnerships and non-dilutive funding opportunities to expand its exosome pipeline and support the commercialization of CAP-1002 [6][20] Company Strategy and Development Direction - The company aims to work closely with the FDA to expedite the filing of a Biologics License Application (BLA) for CAP-1002, with plans to present 24-month follow-up data from the HOPE-2 study in Q2 2023 [13][15] - The company has entered into a second agreement with Nippon Shinyaku for the distribution rights to CAP-1002 in Japan, receiving a $12 million upfront payment and potential milestone payments of up to approximately$89 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's attention to CAP-1002 and the potential for the product to benefit patients with Duchenne muscular dystrophy (DMD) [33] - The company believes that combination therapies will be necessary for long-term disease progression management in DMD, positioning CAP-1002 as a complementary treatment alongside gene therapies [19][40] Other Important Information - The company is on track to release GMP CAP-1002 doses in Q3 2023, which is expected to enhance margins and support the early launch of the product [8] - The company is exploring business development and partnering strategies for its exosome platform, which is focused on developing innovative therapeutic applications [24] Q&A Session Summary Question: Are there any additional rate limiting steps regarding CAP-1002 commercialization? - Management stated that there are no known rate limiting steps at this time and expressed encouragement from the FDA's engagement [33] Question: Any updates on the clinical development timeline for the exosome platform? - Management indicated that internal work is ongoing, with encouraging data regarding targeting specific cell types and exploring partnerships and funding opportunities [34] Question: Will the FDA AdComm meeting for DMD gene therapy affect CAP-1002? - Management believes the entire biotechnology industry will be impacted and emphasized the importance of CAP-1002 as a combination therapy for DMD [40] Question: Any updates on European partnerships and Nippon Shinyaku's interest in Europe? - Management confirmed a strong relationship with Nippon Shinyaku and is considering various options for European rights, potentially including Nippon Shinyaku [50] Question: Will the company commercialize any product independently? - Management plans to take CAP-1002 to the door of commercialization before partnering, ensuring the right partner is selected for rapid market entry [51]