Capricor Therapeutics(US:CAPR)2024-11-14 21:30Financial Performance - Capricor Therapeutics reported clinical development income of approximately $2.3 million for Q3 2024, down from $6.2 million in Q3 2023, and $11.1 million for the nine months ended September 30, 2024, compared to $13.1 million for the same period in 2023[148]. - The company has an accumulated deficit of approximately $192.7 million as of September 30, 2024, with net losses of approximately $12.6 million for Q3 2024 and $33.4 million for the nine months ended September 30, 2024[144]. - Cash used in operating activities for the nine months ended September 30, 2024, was approximately $25.2 million, an increase of $11.2 million compared to the same period in 2023[165]. - The company had cash flow provided by financing activities of approximately $71.7 million for the nine months ended September 30, 2024, compared to $2.4 million for the same period in 2023[167]. Research and Development - Research and Development (R&D) expenses for Q3 2024 increased by approximately $1.8 million, or 18%, compared to Q3 2023, driven by various clinical trial costs and personnel expenses[150]. - Total research and development expenses for the three months ended September 30, 2024, increased by $1,778,903, or 18%, compared to the same period in 2023, totaling $11,807,867[151]. - Compensation and other personnel expenses for the nine months ended September 30, 2024, rose by $3,278,017, or 44%, reaching $10,697,603[153]. - Exosomes platform research expenses increased by $951,089, or 61%, for the nine months ended September 30, 2024, totaling $2,518,052[153]. - The company expects to spend approximately $30.0 million to $35.0 million in 2024 on the deramiocel program for DMD, including clinical and manufacturing expenses[159]. - The company anticipates spending approximately $3.0 million to $5.0 million in 2024 on the development of its exosome platform, focusing on preclinical studies and manufacturing[160]. Product Development and Commercialization - Capricor plans to file a Biologics License Application (BLA) for deramiocel by the end of 2024, following a pre-BLA meeting with the FDA in August 2024[138]. - Deramiocel is designed to slow disease progression in Duchenne muscular dystrophy (DMD) through the actions of cardiosphere-derived cells (CDCs) and has shown statistically significant benefits in clinical trials[134][135]. - Capricor has entered into exclusive distribution agreements with Nippon Shinyaku for deramiocel in the U.S. and Japan, supporting its commercialization strategy[139]. - Capricor's StealthX™ vaccine candidate is part of Project NextGen, with plans for a Phase 1 clinical study expected to begin in Q1 2025[141][142]. Funding and Financial Agreements - Capricor received an upfront payment of $30.0 million from Nippon Shinyaku for the U.S. Distribution Agreement for deramiocel[171]. - The first milestone payment of $10.0 million was received upon completion of the interim futility analysis of the HOPE-3 trial[171]. - Capricor has potential milestones totaling up to $90.0 million leading up to BLA approval for deramiocel[171]. - In the Japan Distribution Agreement, Capricor received an upfront payment of $12.0 million and potential additional milestone payments of up to approximately $89.0 million[173]. - Capricor entered into a Binding Term Sheet with Nippon Shinyaku for the commercialization of deramiocel in Europe, with an upfront payment of $20.0 million and potential milestone payments of up to $715.0 million[175]. - In September 2023, Capricor raised approximately $23.0 million through a registered direct offering of 4,935,621 shares at $4.66 per share[176]. - The ATM Program generated approximately $75.0 million in gross proceeds from the sale of 9,228,383 shares at an average price of $8.13 per share[177]. - Capricor entered into a private placement with Nippon Shinyaku for 2,798,507 shares at a price of $5.36 per share, totaling approximately $15.0 million[178]. - In October 2024, Capricor completed a public offering of 5,073,800 shares at a price of $17.00 per share, generating approximately $86.3 million in gross proceeds[180]. Cash and Investment Management - The company has approximately $85.0 million in cash, cash equivalents, and marketable securities as of September 30, 2024, and raised approximately $86.3 million from a public offering post this date[143]. - Total cash, cash equivalents, and marketable securities as of September 30, 2024, were approximately $85.0 million, up from approximately $39.5 million as of December 31, 2023[164]. - As of September 30, 2024, the fair value of the company's cash, cash equivalents, and marketable securities was approximately $85.0 million[213]. - The company's investment portfolio primarily consists of money market funds, including short-term U.S. treasuries, bank savings, and checking accounts[213]. - The company aims to limit credit exposure by investing with highly rated credit issuers to improve the safety and preservation of invested funds[214]. - The company does not hedge interest rate exposure and believes that a hypothetical 100 basis point increase or decrease in interest rates would not significantly impact the fair value of its investment portfolio[214]. Accounting and Financial Reporting - The company recognizes grant income in the period in which the expense is incurred for reimbursable expenses[198]. - The company accounts for CIRM grant disbursements as long-term liabilities, recognizing them as a liability rather than income[200]. - Research and development expenses primarily consist of salaries, clinical trial costs, and other related expenses, which are expensed as incurred[201]. - The company estimates accrued expenses for clinical trials based on contracts with vendors and adjusts recognition if actual results differ from estimates[209]. - Stock-based compensation expense is recorded over the vesting period, with fair value determined using the Black-Scholes option-pricing model[206]. - The company is currently evaluating the impact of recently issued accounting standards on its financial statement disclosures[211].