Capricor Q4 2022 Earnings Report
Key Takeaways
Capricor Therapeutics reported fourth-quarter revenue of $1.0 million, a net loss of $7.7 million, or $0.31 per share, and cash, cash equivalents, and marketable securities totaling $41.4 million as of December 31, 2022.
Continued to advance clinical development program for CAP-1002 in patients with Duchenne Muscular Dystrophy (DMD), highlighted by the initiation of HOPE-3 Phase 3 trial.
Met with the FDA in a Type-B CMC meeting and discussed manufacturing plans in anticipation of a Biologics License Application (BLA).
Expanded partnership with Nippon Shinyaku to Japan to leverage commercial DMD franchise with $12 million upfront and additional potential milestone payments of up to $89 million.
Reported positive 18-month and one-year results from ongoing HOPE-2 OLE study.
Capricor
Capricor
Forward Guidance
Capricor believes that its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into the fourth quarter of 2024.
Positive Outlook
- Continue discussions with FDA regarding pathway towards BLA for CAP-1002 in DMD
- Present 18-month HOPE-2 OLE results in a late-breaking session at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference being held in Dallas, Texas from March 19-22, 2023
- Plan to present 24-month follow-up data from HOPE-2 OLE in second quarter of 2023
- Plan to report interim analysis of HOPE-3 in fourth quarter of 2023