Capricor Therapeutics(US:CAPR)2025-11-10 22:20Financial Position - As of September 30, 2025, Capricor Therapeutics had cash, cash equivalents, and marketable securities totaling approximately $98.6 million[176]. - Capricor's accumulated deficit as of September 30, 2025, was approximately $274.7 million[177]. - Total cash, cash equivalents, and marketable securities as of September 30, 2025, were approximately $98.6 million, down from $151.5 million as of December 31, 2024[200]. - As of September 30, 2025, total liabilities were approximately $42.6 million, with net working capital of approximately $72.8 million[200]. - As of September 30, 2025, the principal liability balance for the CIRM Award was approximately $3.4 million, with potential accrued interest reaching up to approximately $7.9 million[224][225]. - The fair value of the company's cash, cash equivalents, and marketable securities was approximately $98.6 million[257]. Revenue and Income - The company has no commercial product sales to date and will not generate any commercial product revenue until FDA approval is obtained[179]. - Clinical development income for Q3 2025 was $0, compared to approximately $2.3 million in Q3 2024, with total income for the nine months ended September 30, 2025 being approximately $0 versus $11.1 million in 2024[181]. - The company has not generated any revenue from commercial sales and does not expect to do so for several years, necessitating substantial additional capital for research and development[205]. - The company has not yet achieved commercial sales of its drug candidates, but applies ASU 606 for revenue recognition in distribution agreements[235]. - The company recognizes revenue based on a five-step framework, including identifying contracts and performance obligations, determining transaction prices, and recognizing revenue as obligations are satisfied[236]. Expenses and Losses - For the three months ended September 30, 2025, the net loss was approximately $24.6 million, compared to a net loss of approximately $12.6 million for the same period in 2024[177]. - For the nine months ended September 30, 2025, the net loss was approximately $74.9 million, compared to approximately $33.4 million for the same period in 2024[177]. - The company anticipates significant increases in expenses and operating losses as it seeks to develop and commercialize Deramiocel and other product candidates[178]. - R&D expenses for Q3 2025 increased by approximately $8.6 million, or 72%, to $20.4 million compared to $11.8 million in Q3 2024, driven by increases in personnel costs and clinical trial expenses[184]. - Total G&A expenses for Q3 2025 rose by approximately $2.5 million, or 71%, to $5.9 million compared to $3.5 million in Q3 2024, primarily due to increased personnel and professional service costs[189]. - The company expects to spend approximately $50.0 million to $55.0 million in 2025 on the Deramiocel program, focusing on CMC expansion and pre-commercial expenses[195]. - The exosome platform is projected to incur expenses of approximately $7.0 million to $9.0 million in 2025, primarily for preclinical studies and manufacturing[196]. Cash Flow - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $46.2 million, an increase of $21.0 million compared to $25.2 million in the same period of 2024[202]. - The company had cash flow from investing activities of approximately $54.4 million for the nine months ended September 30, 2025, compared to $7.2 million in 2024, due to marketable securities transactions and capital expenditures[203]. - Cash flow provided by financing activities was $76.884 million for the nine months ended September 30, 2025, down from approximately $71.7 million in the same period of 2024[204]. Funding and Agreements - Capricor received an upfront payment of $30 million in 2022 under a U.S. Distribution Agreement with Nippon Shinyaku, with potential milestone payments totaling $100 million[211]. - Under the Japan Distribution Agreement, Capricor received an upfront payment of $12 million and may receive additional milestone payments of up to approximately $89 million[213]. - A Binding Term Sheet with Nippon Shinyaku for Europe includes potential milestone payments of up to $715 million, subject to finalization of a definitive agreement[214]. - The company raised approximately $86.3 million from a public offering in October 2024 at a price of $17.00 per share[216]. - In a private placement in September 2024, the company sold 2,798,507 shares at $5.36 per share for approximately $15 million[217]. - The company established an at-the-market offering program in September 2025 for aggregate sales proceeds of up to $150 million[219]. Going Concern - The company has substantial doubt about its ability to continue as a going concern, lacking sufficient funds to support operations for at least twelve months from the filing date[207]. Clinical Trials and Product Development - The Phase II HOPE-2 trial of Deramiocel met its primary endpoint with a p-value of 0.01 and secondary endpoints including full PUL v2.0 with a p-value of 0.04[166]. - The HOPE-3 Phase 3 clinical trial is evaluating the safety and efficacy of Deramiocel in 105 boys with DMD, with topline data expected in the fourth quarter of 2025[164]. - Deramiocel has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA) for the treatment of DMD[168]. - Capricor has entered into exclusive commercialization and distribution agreements with Nippon Shinyaku for the United States and Japan[169]. Accounting and Financial Reporting - R&D expenses primarily consist of salaries, clinical trial costs, and other related expenses, with costs expensed as incurred[243]. - The company utilizes estimates for clinical trial accruals based on contracts with various vendors, with adjustments made as necessary[244]. - Stock-based compensation is recorded as non-cash expense, with fair value determined using the Black-Scholes model for stock options[250]. - The company has issued stock options and restricted stock awards under multiple plans, with expenses included in general and administrative or R&D expenses[251]. - The company aims to mitigate market risk by investing in high credit quality securities, with no current hedging of interest rate exposure[258]. - The company expects to record additional non-cash compensation expense in the future, which may be significant[251]. - The company evaluates the impact of newly issued accounting standards on its financial statements, including ASU 2025-06 and ASU 2024-03[254][255].