Capricor Therapeutics(US:CAPR)2023-03-16 16:00Financial Performance and Position - The company has not yet achieved commercial sales of its drug candidates, but it applies ASU 606 for revenue recognition in distribution agreements[39]. - The company accounts for CIRM grant disbursements as long-term liabilities, recognizing them as a liability rather than income[42]. - The company has incurred substantial losses historically and is likely to sustain operating expenses without corresponding revenues for the foreseeable future[60]. - As of December 31, 2022, the fair value of Capricor's cash, cash equivalents, and marketable securities was approximately $41.4 million[933]. - The aggregate market value of Capricor's common stock held by non-affiliates as of June 30, 2022, was approximately $82.67 million, based on a stock price of $3.49 per share[82]. - Capricor has 25,255,154 shares of common stock issued and outstanding as of March 16, 2023[82]. Research and Development - The company has promising preclinical data for CAP-2003, with an IND filed with the FDA in 2020 for investigation in patients with DMD[70]. - The core cell therapy technology, based on cardiosphere-derived cells (CDCs), has been administered to over 200 human subjects across several clinical trials[71]. - The company is evaluating next steps for the CAP-2003 program following FDA requests for more information related to manufacturing[70]. Market Conditions and Risks - Recent global market and economic conditions have been unpredictable, potentially affecting the company's liquidity and financial condition[74]. - The merger with Nile Therapeutics resulted in an "ownership change," which may limit the company's ability to utilize net operating loss and tax credit carryforwards[52]. - Management's projections and forecasts are subject to inherent risks and may not reliably predict future results[79]. - The company’s operational projections reflect numerous assumptions that may prove inaccurate, leading to material differences between actual and projected results[79]. Investment and Financial Strategy - Capricor's investment portfolio primarily consists of money market funds and short-term U.S. treasuries, aimed at limiting credit exposure and preserving invested funds[934]. - The company does not hedge interest rate exposure and believes that a hypothetical 100 basis point change in interest rates would not significantly impact the fair value of its investment portfolio[935]. - Capricor's investment policy focuses on high credit quality securities to mitigate default risk[934]. - The company expects to issue additional stock awards and shares in the future, which may dilute the interests of existing security holders[47]. Collaborations and Partnerships - The company collaborates with several institutions, including Johns Hopkins University and the Department of Defense, to support its exosome platform program[69].