Anticipated Milestones and Events
The Company has set forth the following guidance for pipeline progression:
| ● | Continue discussions with FDA regarding our pathway towards BLA for CAP-1002 in DMD |
| o | Plan to share FDA feedback on the HOPE-3 clinical trial once final minutes are available |
| ● | Plan to submit data from the ongoing HOPE-2-OLE study at a medical meeting in the fourth quarter of 2023 |
| ● | Plan to complete enrollment of the currently designed HOPE-3 trial in the fourth quarter of 2023 |
| ● | Plan to report outcome from interim analysis of HOPE-3 in fourth quarter of 2023 |
| ● | Continue to explore opportunities for additional partnerships outside of the U.S. and Japan to support the potential commercialization of CAP-1002 in DMD |
Second Quarter 2023 Financial Results
Cash position: The Company’s cash, cash equivalents and marketable securities totaled approximately $37.8 million as of June 30, 2023 compared to approximately $41.4 million on December 31, 2022. Additionally, in the second quarter of 2023, Capricor raised approximately $2.1 million in net proceeds through issuances of common stock at an average price of approximately $4.87 per share under its at-the-market offering program.
Revenues: Capricor’s primary source of revenue was from the ratable recognition of the $30.0 million upfront payment in accordance with its U.S. Exclusive Commercialization and Distribution Agreement received from Nippon Shinyaku in the first quarter of 2022. Revenues for the second quarter of 2023 were approximately $3.9 million compared with zero for the second quarter of 2022. Additionally, revenues for the first half of 2023 were approximately $6.9 million compared with zero for the first half of 2022.
Operating expenses: Total operating expenses for the second quarter of 2023 were approximately $11.7 million compared with approximately $7.3 million for the second quarter of 2022. Total operating expenses for the first half of 2023 were approximately $22.8 million compared with approximately $15.2 million for the first half of 2022.
Net loss: The Company reported a net loss of approximately $7.4 million, or $0.29 per share, for the second quarter of 2023, compared to a net loss of approximately $7.1 million, or $0.29 per share, for the second quarter of 2022. The Company reported a net loss of approximately $15.1 million, or $0.60 per share, for the first half of 2023, compared to a net loss of approximately $14.9 million, or $0.61 per share, for the first half of 2022.
Financial Outlook
Capricor believes that based on the current operating plan and financial resources, its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements through the third quarter of 2024. This expectation excludes any additional potential milestone payments under its exclusive commercialization and distribution agreements with Nippon Shinyaku as well as any strategic use of capital not currently in the Company’s base-case planning assumptions.
Conference Call and Webcast
To participate in the conference call, please dial 888-886-7786 (Domestic/Toll-Free) or 416-764-8658 (International) and reference the conference ID: 02236204. To participate via a webcast, please click here. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for