Financial 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].

Financial Performance - Revenues for Q3 2025 were $0, a decrease from approximately $2.3 million in Q3 2024; revenues for the first nine months of 2025 were also $0, down from approximately $11.1 million in the same period of 2024[10]. - Total operating expenses for Q3 2025 were approximately $26.3 million, compared to approximately $15.3 million for Q3 2024; total operating expenses for the first nine months of 2025 were approximately $79.0 million, up from approximately $46.0 million in the same period of 2024[11]. - The net loss for Q3 2025 was approximately $24.6 million, or $0.54 per share, compared to a net loss of approximately $12.6 million, or $0.38 per share, for Q3 2024[12]. - Total revenue for Q3 2025 was $0, compared to $2,261,642 in Q3 2024, representing a decrease of 100% year-over-year[26]. - The net loss for Q3 2025 was $24,570,647, compared to a net loss of $12,556,728 in Q3 2024, indicating a 96% increase in losses[26]. - The net loss per share for Q3 2025 was $0.54, compared to $0.38 in Q3 2024, reflecting a 42% increase in loss per share[26]. - Comprehensive loss for Q3 2025 was $25,114,099, compared to $12,615,494 in Q3 2024, indicating a 99% increase in comprehensive losses[26]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled approximately $98.6 million as of September 30, 2025, down from approximately $151.5 million as of December 31, 2024[9]. - Cash, cash equivalents, and marketable securities decreased to $98,565,971 as of September 30, 2025, down from $151,515,877 at the end of 2024, a decline of 35%[28]. - Total assets decreased to $126,438,207 as of September 30, 2025, from $170,481,086 at the end of 2024, a reduction of 26%[28]. - Total liabilities increased to $42,570,952 as of September 30, 2025, compared to $25,018,750 at the end of 2024, an increase of 70%[28]. Research and Development - A Phase 1 clinical trial for the StealthX™ exosome-based vaccine is ongoing, with initial topline data expected in Q1 2026[5]. - Topline results from the pivotal HOPE-3 Phase 3 study (n=105) of Deramiocel for Duchenne muscular dystrophy are expected in Q4 2025[5]. - Research and development expenses increased to $20,359,098 in Q3 2025, up from $11,807,867 in Q3 2024, reflecting a 72% increase[26]. Regulatory and Operational Updates - Capricor plans to resubmit its Biologics License Application (BLA) pending the results of the HOPE-3 study, with a review period anticipated to be up to six months[6]. - The company has completed its FDA Pre-License Inspection for its GMP facility, which is now operational and ready for initial commercial launch upon approval[6]. - Deramiocel has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency for the treatment of Duchenne muscular dystrophy[18]. Shareholder Information - The weighted average number of shares outstanding increased to 45,716,151 in Q3 2025 from 33,090,063 in Q3 2024[26]. - Capricor's available cash is expected to cover anticipated expenses into Q4 2026, excluding any additional potential milestone payments[13].

Core Insights - Capricor Therapeutics is approaching a critical phase in its development with the upcoming topline results from the HOPE-3 Phase 3 trial of Deramiocel for Duchenne muscular dystrophy (DMD) [2][4][5] - The company has prepared for a potential commercial launch of Deramiocel in 2026, contingent on the trial results and regulatory approval [4][5] - Financial results indicate a significant increase in operating expenses and a net loss for the third quarter of 2025 compared to the same period in 2024 [9][10] Company Updates - The topline results from the HOPE-3 Phase 3 study, which includes 105 participants, are expected in Q4 2025 [4][5] - Following a recent Type A meeting with the FDA, Capricor plans to resubmit its Biologics License Application (BLA) using the HOPE-3 results to address previous concerns raised in a Complete Response Letter [5] - The company has completed its FDA Pre-License Inspection for its commercial manufacturing facility, which is now operational and ready for initial product launch [5] Financial Performance - As of September 30, 2025, Capricor reported cash, cash equivalents, and marketable securities totaling approximately $98.6 million, down from $151.5 million at the end of 2024 [7][25] - Revenues for Q3 2025 were $0, a decrease from approximately $2.3 million in Q3 2024, with total revenues for the first nine months of 2025 also at $0 compared to approximately $11.1 million in the same period of 2024 [8] - Total operating expenses for Q3 2025 were approximately $26.3 million, up from approximately $15.3 million in Q3 2024, leading to a net loss of approximately $24.6 million for Q3 2025 compared to a net loss of approximately $12.6 million in Q3 2024 [9][10] Upcoming Developments - Capricor is preparing for a commercial launch of Deramiocel in 2026, pending the results of the HOPE-3 trial [4][5] - The company is also advancing its StealthX™ exosome-based vaccine platform, with initial data from a Phase 1 clinical trial expected in Q1 2026 [4][6]

Earnings Reports Overview - The earnings season is slowing down, but several retail-favorite companies are set to report this week [1] - Key companies reporting include Barrick Mining Corp., Plug Power Inc., Oklo Inc., Cisco Systems Inc., Walt Disney Co., and Applied Materials Inc. [2][3][5][10][11] Company-Specific Insights - Barrick Mining Corp. reported its third-quarter results before the market opened on November 10 [2] - Plug Power Inc. is expected to report losses of 12 cents per share and revenue of $179.54 million, having missed earnings expectations for the last 18 quarters [3] - Oklo Inc. is anticipated to report losses of 13 cents per share and revenue of $17.01 billion, with stock volatility noted ahead of the report [5] - Cisco Systems Inc. is expected to be a focal point for investors, particularly regarding management's guidance and updates on AI and cybersecurity business momentum [10] - Walt Disney Co. and JD.com Inc. will release earnings reports before the market opens on November 13 [11] - Applied Materials Inc. is set to release its Q4 results after the market closes on November 13 [11] Additional Companies Reporting - Other companies reporting this week include Workhorse Group Inc., Beyond Meat Inc., Microvision Inc., and Virgin Galactic Holdings Inc. [4][6][12]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Insights - Capricor Therapeutics has published a study on Deramiocel's anti-fibrotic activity, highlighting a validated potency assay that supports quality control in late-stage development for Duchenne muscular dystrophy (DMD) [1][4] Company Overview - Capricor Therapeutics is focused on developing cell and exosome-based therapies for rare diseases, with Deramiocel as its lead investigational product [1][10] - The company has received multiple designations for Deramiocel, including Orphan Drug Designation from the U.S. FDA and EMA, and Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. [7] Research Findings - The publication details a novel in-vitro potency assay that characterizes the anti-fibrotic mechanism of action of cardiosphere-derived cells (CDCs) in Deramiocel, showing that CDCs can suppress collagen I and III gene expression in human fibroblasts [2][3] - Consistent findings across over one hundred manufacturing lots of Deramiocel demonstrate its anti-fibrotic mechanism, aligning with in vivo studies and clinical data showing stabilization of cardiac function in DMD patients [3] Clinical Development - Deramiocel is currently being evaluated in the Phase 3 HOPE-3 trial, with topline data expected in mid-fourth quarter of 2025 [4][8] - The HOPE-3 trial is a multi-center, randomized, double-blind, placebo-controlled study involving 105 eligible subjects [8][9] Mechanism of Action - Deramiocel consists of allogeneic CDCs that exert immunomodulatory and anti-fibrotic actions, preserving cardiac and skeletal muscle function in muscular dystrophies [6][10] - CDCs secrete exosomes that target macrophages, promoting a healing phenotype rather than a pro-inflammatory one [6] Educational Initiatives - To complement the publication, Capricor has released an educational video explaining the mechanism of action of Deramiocel [5]

Core Insights - Capricor Therapeutics will release its financial results for Q3 2025 on November 10, 2025, followed by a conference call at 4:30 p.m. ET [1] - The company is focused on developing cell and exosome-based therapeutics for rare diseases, with its lead product candidate being Deramiocel for Duchenne muscular dystrophy (DMD) [2] Company Overview - Capricor Therapeutics is dedicated to advancing transformative therapies, particularly through its lead candidate Deramiocel, which is in late-stage clinical development for DMD [2] - Deramiocel has shown potent immunomodulatory and anti-fibrotic effects in preserving cardiac and skeletal muscle function in DMD patients [2] - The company is also utilizing its proprietary StealthX™ platform for the targeted delivery of therapeutics, with applications in vaccinology and treatment of various diseases [2] Recent Developments - Capricor has entered into an exclusive commercialization agreement for Deramiocel in the U.S. and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [5]

Core Insights - Capricor Therapeutics (CAPR) shares increased by 12% to close at $6.92, following a 14.3% decline over the past four weeks, indicating a significant turnaround in investor sentiment [1][2]. Company Performance - The recent rise in CAPR shares is linked to the company's regulatory advancements and optimism regarding upcoming clinical milestones, particularly after management confirmed FDA alignment on trial endpoints [2]. - The company is projected to report a quarterly loss of $0.54 per share, reflecting a year-over-year decrease of 42.1%, while revenues are expected to reach $2.4 million, marking a 6.2% increase from the previous year [3]. - The consensus EPS estimate for Capricor has remained stable over the last 30 days, suggesting that the stock's price movement may not sustain without changes in earnings estimate revisions [4]. Industry Context - Capricor operates within the Zacks Medical - Products industry, where LeMaitre Vascular (LMAT) is another player, having closed at $88.87 with a 0.8% decline in the last trading session [5]. - LeMaitre's consensus EPS estimate has increased by 2.9% over the past month to $0.57, representing a year-over-year change of 16.3% [6].

Core Insights - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of Capricor Therapeutics, Inc. (NASDAQ: CAPR) [1] - The investigation is based on a federal securities lawsuit alleging that insiders provided misleading information regarding the company's lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy [1] - The lawsuit claims that while Capricor communicated its ability to obtain a Biologics License Application (BLA) from the FDA, it also concealed adverse facts related to the safety and efficacy data from its Phase 2 HOPE-2 trial [1] Company Investigation - The investigation focuses on whether Capricor's management misled investors about the prospects of deramiocel [1] - The allegations include the dissemination of false statements and the concealment of material adverse facts regarding the drug's four-year safety and efficacy data [1] Shareholder Actions - Shareholders who purchased CAPR shares prior to October 9, 2024, are encouraged to contact Kuehn Law for potential legal action [2] - Kuehn Law offers to cover all case costs and does not charge its investor clients, emphasizing the importance of shareholder participation in maintaining market integrity [3]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Capricor Therapeutics, Inc. following a class action complaint regarding breaches of fiduciary duties by the board of directors during the specified class period [1]. Group 1: Legal Investigation - The law firm is encouraging long-term stockholders of Capricor, specifically those who held shares between October 9, 2024, and July 10, 2025, to discuss their legal rights [1][3]. - A class action complaint was filed against Capricor on July 17, 2025, focusing on the actions of the company's board of directors [1]. Group 2: Company Performance and Issues - The complaint alleges that Capricor misled investors regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [7]. - Capricor's statements included claims about obtaining a Biologics License Application (BLA) from the FDA, while concealing adverse facts about the safety and efficacy data from its Phase 2 HOPE-2 trial [7]. - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the BLA due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [7].