Capricor Therapeutics(CAPR)2023-11-13 16:00Financial Performance - For the three months ended September 30, 2023, clinical development income was approximately 1.6 million in the same period of 2022, representing a significant increase [112]. - The company reported net losses of approximately 21.5 million for the nine months ended September 30, 2023, compared to 21,525,453 compared to a net loss of 6.5 million for the three months ended September 30, 2023, compared to 6.3 million for the same period in 2022 [226]. Research and Development Expenses - Research and development (R&D) expenses for the nine months ended September 30, 2023, increased by approximately 10.9 million, or 70%, compared to the same period in 2022, primarily driven by ongoing clinical trials and expanded manufacturing efforts [114]. - Research and development (R&D) expenses for the three months ended September 30, 2023 increased by approximately 10,028,964 [126]. - Research and development costs for the three months ended September 30, 2023, were approximately 5.5 million for the same period in 2022 [233]. - For the nine months ended September 30, 2023, research and development costs totaled approximately 15.6 million in 2022 [233]. - CAP-1002 program for Duchenne muscular dystrophy (DMD) incurred expenses of 2,045,997 in the same period in 2022 [126]. Cash Flow and Liquidity - Total cash, cash equivalents, and marketable securities as of September 30, 2023 were approximately 41.4 million as of December 31, 2022 [144]. - Cash used in operating activities for the nine months ended September 30, 2023 was approximately 11.8 million in the same period in 2022 [136]. - Cash and cash equivalents balance at the end of the period was 34,885,274 at the beginning of the period [191]. - The company’s principal uses of cash include research and development expenses, general and administrative expenses, and capital expenditures [185]. - The company’s future capital requirements may be substantial, with potential financing options including equity or debt securities and government grants [198]. Offerings and Financing - The company completed a registered direct offering on October 3, 2023, raising approximately 4.66 per share [107]. - On October 3, 2023, the company entered into Securities Purchase Agreements to issue 4,935,621 shares at a price of 23.0 million [151]. - The company has sold an aggregate of 2,620,703 shares under its ATM Program at an average price of approximately 15.0 million [152]. - Capricor received an upfront payment of 100.0 million [157]. Clinical Trials and Development - CAP-1002's HOPE-3 clinical trial has reached its target enrollment of 58 patients, with Cohort B expected to commence enrollment in the fourth quarter of 2023 [102]. - The company plans to report the outcome from the interim futility analysis of the CAP-1002 program in the fourth quarter of 2023 and top-line data from Cohort A in the fourth quarter of 2024 [93]. - The FDA affirmed alignment on the current HOPE-3 clinical trial design during a Type-B clinical meeting held in the third quarter of 2023, supporting the submission of a Biologics License Application (BLA) for CAP-1002 [94]. General and Administrative Expenses - General and administrative (G&A) expenses for the three months ended September 30, 2023 increased by approximately 3,021,450 [122]. - Total general and administrative expenses for Q3 2023 were 943,075 in Q3 2022, representing a 31% increase [276]. Other Financial Metrics - The company has an accumulated deficit of approximately 38.9 million, with 3.4 million related to the CIRM Award as of September 30, 2023 [154]. - The company has not recognized an income tax benefit due to uncertainty regarding realization [260].