Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K þ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2025 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) (State or other jurisdiction of inco ...

Core Viewpoint - Capricor Therapeutics Inc is facing significant financial challenges but is optimistic about its future due to ongoing clinical developments and a favorable consensus price target from analysts [4][6]. Financial Performance - The company is preparing to release its quarterly earnings on March 18, 2026, with an estimated earnings per share (EPS) of -$0.51 and projected revenue of $525,000 [1][6]. - Capricor's financial metrics indicate severe difficulties, including a negative return on equity of -99.57% and a return on assets of -76.16% [2][6]. - The company reported a quarterly loss of 62 cents per share, which is worse than the anticipated 54-cent loss, and revenue dropped to zero from $11.1 million the previous year [5]. Debt and Equity - Despite its financial struggles, Capricor maintains a low debt-to-equity ratio of 0.17, suggesting manageable debt levels [2][6]. Market Outlook - Analysts have a consensus price target of $46.09 for Capricor, indicating a potential upside of 51.12% [4][6]. - The company's cash balance of approximately $318 million is expected to sustain operations through 2027, providing a buffer for ongoing developments [4]. Clinical Developments - Capricor is making progress in its clinical developments, particularly with the FDA's review of their Biologics License Application for Deramiocel and the successful HOPE-3 Phase 3 trial [4][5].

Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing its offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing its extensive coverage and growth in the transcript publishing sector [1] - There is an ongoing effort to expand coverage, suggesting a strategic initiative to capture more market share and improve service offerings [1]

Core Viewpoint - Capricor Therapeutics is experiencing bearish pressure on its stock due to disappointing financial results, despite positive developments in its clinical trials and analyst support. Financial Performance - Capricor reported a quarterly loss of 62 cents per share, missing the consensus estimate of a 54-cent loss and worsening from a 16-cent loss in the prior-year period [2] - Quarterly revenue fell to zero from approximately $11.1 million a year earlier, while total operating expenses increased to roughly $29.2 million from $18.8 million [2] - The fourth-quarter net loss widened to about $30.2 million from $7.1 million [2] Clinical Developments - Capricor announced that its Phase 3 HOPE-3 trial met its primary endpoint, which is a positive indicator for the company's future prospects [3] - The biologics license application for deramiocel is currently under FDA review, with a PDUFA target action date set for August 22 [3] Cash Position - As of the end of 2025, Capricor had approximately $318.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2027 [3] Analyst Ratings - HC Wainwright reiterated a Buy rating with a price target of $60, while Piper Sandler raised its price target to $58 from $45, maintaining an Overweight rating [4] Stock Performance - Capricor shares have shown strong bullish momentum, rising from a low of about $4.60 in late 2025 to a recent high near $33.57 [5] - The stock is currently trading well above its 20-, 50-, and 200-day moving averages, indicating strong bullish momentum [5] Recent Price Action - As of the latest publication, Capricor Therapeutics shares were down 5.69% at $31.52 [6]

Financial Data and Key Metrics Changes - As of December 31, 2025, the company's cash position was approximately $318.1 million, significantly increased from approximately $151.5 million as of December 31, 2024 [29] - Revenue for the fourth quarter of 2025 was $0, down from approximately $11.1 million for the same period in 2024, and full-year revenue for 2025 was also $0 compared to approximately $22.3 million in 2024 [29][30] - Total operating expenses for Q4 2025 were approximately $29.2 million, up from approximately $18.8 million in Q4 2024, and full-year operating expenses for 2025 were approximately $108.1 million compared to approximately $64.8 million in 2024 [30][31] - Net loss for Q4 2025 was approximately $30.2 million, compared to a net loss of approximately $7.1 million in Q4 2024, and the full-year net loss for 2025 was approximately $105 million compared to approximately $40.5 million in 2024 [31] Business Line Data and Key Metrics Changes - The company is focused on advancing Deramiocel toward potential approval for Duchenne muscular dystrophy (DMD) in the U.S., with a Biologics License Application (BLA) under review by the FDA [5][19] - The HOPE-3 trial results indicated a 91% slowing of disease progression in evaluable patients, with statistically significant results in patients with cardiomyopathy [10][11] - The company aims to position Deramiocel to treat as many eligible patients as possible, with a focus on both skeletal and cardiac disease manifestations of DMD [6][7] Market Data and Key Metrics Changes - The FDA has assigned a PDUFA target action date of August 22, 2026, for the review of the BLA for Deramiocel [5][19] - The company is preparing for a potential commercial launch and has completed its FDA pre-license inspection for its manufacturing facility [20][21] - The current manufacturing facility can support approximately 250 patients per year, with plans to expand capacity to accommodate up to 2,500 patients annually by late 2027 [21] Company Strategy and Development Direction - The company is building an infrastructure to support the launch and commercialization of Deramiocel while expanding its pipeline to treat other indications [8][22] - The focus is on executing a disciplined approach to commercialization, including market access, reimbursement planning, and physician education [22] - The company is also exploring expansion into other diseases, initially focusing on Becker muscular dystrophy [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting Deramiocel's potential benefit in treating DMD, emphasizing the importance of addressing both skeletal and cardiac aspects of the disease [18] - The company is optimistic about its financial position, with sufficient capital to support operations into the fourth quarter of 2027 [27] - Management highlighted the importance of early intervention in DMD treatment and the potential for Deramiocel to be used in younger patients [75] Other Important Information - The company completed a public offering in December 2025, resulting in net proceeds of approximately $162 million [29] - Capricor's common stock was approved for uplisting to the Nasdaq Global Select Market, enhancing visibility within the institutional investment community [28] Q&A Session Summary Question: Anticipation of Ad Comm and Commercial Prep for Deramiocel Approval - Management indicated uncertainty regarding an Ad Comm but expressed confidence in the strength of the HOPE-3 data regardless of whether an Ad Comm occurs [34][35] Question: Labeling Discussions and Expectations - Management noted that labeling discussions have not yet occurred but believes the data supports a label for both DMD and cardiomyopathy [38][52] Question: Cohorts of HOPE-3 Trial and FDA Considerations - Management clarified that the FDA considers Cohort A and Cohort B as one trial and expressed confidence in the statistical significance of Cohort B [44][45] Question: Manufacturing Capacity and Expansion Plans - Management confirmed plans to expand manufacturing capacity to accommodate more patients and emphasized the importance of regulatory compliance [58][70] Question: Early Intervention and Treatment of DMD - Management highlighted the importance of early intervention and the potential for Deramiocel to be used in younger patients, while acknowledging the challenges of obtaining a prevention label [75] Question: European Rights Deal Status - Management indicated that negotiations with NS Pharma for European rights are ongoing and will be prioritized following the PDUFA date [77]

Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled approximately $318.1 million, a significant increase from approximately $151.5 million as of December 31, 2024 [26] - Revenue for the fourth quarter of 2025 was $0, compared to approximately $11.1 million for the same period in 2024, and full-year revenue for 2025 was also $0, down from approximately $22.3 million in 2024 [26][27] - Total operating expenses for Q4 2025 were approximately $29.2 million, up from approximately $18.8 million in Q4 2024, and full-year operating expenses for 2025 were approximately $108.1 million, compared to approximately $64.8 million in 2024 [27][28] - Net loss for Q4 2025 was approximately $30.2 million, compared to a net loss of approximately $7.1 million in Q4 2024, and the full-year net loss for 2025 was approximately $105 million, up from approximately $40.5 million in 2024 [28][29] Business Line Data and Key Metrics Changes - The company is focused on advancing Deramiocel toward potential approval for Duchenne muscular dystrophy (DMD) in the U.S., with a Biologics License Application (BLA) under review by the FDA [5][6] - The HOPE-3 trial, a pivotal phase 3 study, enrolled 106 patients and met its primary efficacy endpoint, showing a 91% slowing of disease progression in evaluable patients [9][10] - The company aims to position Deramiocel to treat as many eligible patients as possible, with a focus on both skeletal and cardiac disease manifestations of DMD [6][7] Market Data and Key Metrics Changes - The FDA has accepted the BLA for review with a target action date of August 22, 2026, marking a significant regulatory milestone for the company [5][17] - The company is preparing for a potential commercial launch and has completed its FDA pre-license inspection for its manufacturing facility [18][19] Company Strategy and Development Direction - The company is building an infrastructure to support the launch and commercialization of Deramiocel while expanding its pipeline to treat other indications [8][20] - The company is also exploring potential expansion into other diseases, initially focusing on Becker muscular dystrophy [21] - The company is committed to maintaining a disciplined approach to execution and investing in its pipeline to operate as a world-class commercial biotech company [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting Deramiocel and its potential to become a foundational therapy for DMD [16][24] - The company believes it is well-positioned for growth, with a strong balance sheet and operational readiness for commercial launch [8][25] - Management highlighted the importance of addressing the unmet need in the DMD community and the urgency to provide Deramiocel to patients [19][70] Other Important Information - The company completed a public offering in December 2025, resulting in net proceeds of approximately $162 million, which strengthens its financial position [26] - The company is also working on its exosome platform, with ongoing studies related to a COVID vaccine and plans for future therapeutic applications [22][101] Q&A Session Summary Question: Anticipation of Ad Com and Commercial Preparation - Management indicated that there has been no movement towards an Advisory Committee meeting at this point, and they are preparing for commercial readiness regardless [33][34] Question: Labeling Discussions and Expectations - Management noted that they have not had detailed labeling discussions yet but believe the data supports a label for both DMD and cardiomyopathy [36][52] Question: Cohorts in HOPE-3 Trial - Management clarified that the FDA considers the two cohorts of the HOPE-3 trial as one clinical trial, and both cohorts showed statistically significant results [44] Question: Transition of Clinical Trial Patients to Commercial Drug - Management confirmed that they expect to transition all clinical trial patients to the commercial drug and are planning for market access to facilitate this [67][70] Question: Early Intervention and Labeling - Management emphasized the importance of early intervention and is focusing on younger patients, although obtaining a prevention label is challenging [76] Question: Manufacturing Capacity and Expansion Plans - Management is actively planning to expand manufacturing capabilities to accommodate more patients as needed [70][71]

Financial Data and Key Metrics Changes - As of December 31, 2025, cash equivalents and marketable securities totaled approximately $318.1 million, up from approximately $151.5 million as of December 31, 2024 [24] - Revenue for Q4 2025 was $0, compared to approximately $11.1 million for Q4 2024, and for the full year 2025, revenue was also $0, down from approximately $22.3 million in 2024 [24] - Total operating expenses for Q4 2025 were approximately $29.2 million, compared to approximately $18.8 million for Q4 2024, with full-year operating expenses at approximately $108.1 million, up from approximately $64.8 million in 2024 [25] - Net loss for Q4 2025 was approximately $30.2 million, compared to a net loss of approximately $7.1 million for Q4 2024, and for the full year 2025, the net loss was approximately $105 million, compared to approximately $40.5 million in 2024 [26] Business Line Data and Key Metrics Changes - The company is focused on advancing Deramiocel for Duchenne muscular dystrophy (DMD), with a Biologics License Application (BLA) under review by the FDA [4][5] - The HOPE-3 trial showed significant results, including a 91% slowing of disease progression in left ventricular ejection fraction among evaluable patients [7][8] - The company aims to position Deramiocel to treat as many eligible patients as possible, with a focus on both skeletal and cardiac disease manifestations of DMD [5][6] Market Data and Key Metrics Changes - The FDA has accepted the BLA for review with a target action date of August 22, 2026, marking a significant regulatory milestone for the company [4][15] - The company is preparing for a potential commercial launch and has completed its FDA pre-license inspection for its manufacturing facility [16][17] Company Strategy and Development Direction - The company is building an infrastructure to support the launch and commercialization of Deramiocel while expanding its pipeline to treat other indications [6][19] - The company is also exploring expansion into other diseases, initially focusing on Becker muscular dystrophy [19] - The company is committed to maintaining a disciplined approach to execution and investing in its pipeline to operate as a world-class commercial biotech company [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data and the company's manufacturing readiness, positioning it well for growth [6][15] - The company is focused on addressing the unmet needs of the DMD community and is preparing for a potential commercial launch [17][18] - Management highlighted the importance of the HOPE-3 trial data in supporting the therapeutic profile of Deramiocel [14][15] Other Important Information - The company ended 2025 with a strong cash position of approximately $318 million, which is expected to fund operations into the fourth quarter of 2027 [22] - The company has been approved for uplisting to the Nasdaq Global Select Market, enhancing visibility within the institutional investment community [23] Q&A Session Summary Question: Anticipation of Ad Com and commercial preparation for Deramiocel approval - Management indicated that there has been no movement towards an Advisory Committee meeting and expressed confidence in the strength of the HOPE-3 data regardless of the review process [30][32] Question: Clarification on the label for Deramiocel - Management believes the data supports a label for both DMD and cardiomyopathy, with ongoing discussions with the FDA [34][35] Question: Status of the two cohorts in the HOPE-3 trial - Management confirmed that the FDA considers the two cohorts as one trial and expressed confidence in the statistical significance of cohort B [39][41] Question: Expectations for the peer-reviewed publication of HOPE-3 data - Management stated that the academic review process is ongoing and updates will be provided once the publication is ready [42] Question: Insights from the Muscular Dystrophy Association meeting - Management noted that the HOPE-3 data has solidified belief in Deramiocel among physicians and increased inquiries about prescribing and availability [60] Question: Plans for scaling manufacturing capacity - Management confirmed plans for additional manufacturing build-out to accommodate more patients, contingent on the successful response to the BLA [66][67]

Financial Position - Capricor's cash position as of December 31, 2025, was approximately $318.1 million, up from $151.5 million a year earlier, following a public offering that generated net proceeds of approximately $161.9 million[7] - Cash, cash equivalents, and marketable securities totaled $318,128,915 as of December 31, 2025, up from $151,515,877 at the end of 2024, indicating a growth of 110%[24] - Total assets increased to $355,949,294 in 2025 from $170,481,086 in 2024, representing a growth of 108%[24] - Total liabilities rose to $50,157,149 in 2025, compared to $25,018,750 in 2024, an increase of 100%[24] - Capricor expects its available cash and equivalents to cover anticipated expenses through 2027, excluding additional potential milestone payments[12] Revenue and Expenses - Revenues for Q4 2025 were $0, a decrease from approximately $11.1 million in Q4 2024, with total revenues for the year also at $0 compared to approximately $22.3 million in 2024[8] - Total operating expenses for Q4 2025 were approximately $29.2 million, compared to approximately $18.8 million in Q4 2024, with total operating expenses for the year at approximately $108.1 million, up from approximately $64.8 million in 2024[9] - Research and development expenses increased to $23,132,671 in Q4 2025 from $14,554,936 in Q4 2024, marking a rise of 59%[22] - General and administrative expenses rose to $6,024,937 in Q4 2025 compared to $4,273,414 in Q4 2024, an increase of 41%[22] Net Loss - The net loss for Q4 2025 was approximately $30.2 million, or $0.62 per share, compared to a net loss of approximately $7.1 million, or $0.16 per share, in Q4 2024; the net loss for the full year was approximately $105.0 million, or $2.26 per share, compared to approximately $40.5 million, or $1.15 per share, in 2024[10] - The net loss for Q4 2025 was $30,170,914, compared to a net loss of $7,116,603 in Q4 2024, reflecting a significant increase in losses[22] - The comprehensive loss for Q4 2025 was $30,731,882, compared to a comprehensive loss of $6,185,869 in Q4 2024, indicating a substantial increase in losses[22] - The net loss per share for Q4 2025 was $(0.62), compared to $(0.16) in Q4 2024, reflecting a worsening loss per share situation[22] Clinical and Regulatory Developments - The Biologics License Application (BLA) for Deramiocel is under FDA review with a PDUFA target action date of August 22, 2026[5] - The pivotal HOPE-3 Phase 3 trial met its primary endpoint and key secondary cardiac endpoint, achieving statistical significance with p-values of 0.03 and 0.04, respectively[6] - Capricor's GMP manufacturing facility in San Diego is operational and has completed an FDA Pre-License Inspection, positioning it for a potential commercial launch[11] - The ongoing Phase 1 clinical trial for the StealthX™ exosome-based vaccine platform has shown favorable safety profiles, with final results expected in Q2 2026[11] Market Position - The company has been uplisted to the Nasdaq Global Select Market, representing its highest listing tier[11] - The weighted average number of shares outstanding increased to 48,850,452 in Q4 2025 from 44,509,154 in Q4 2024, a rise of 10%[22]

Core Insights - Capricor Therapeutics is advancing its lead product candidate, Deramiocel, for Duchenne muscular dystrophy (DMD) with a Biologics License Application (BLA) currently under FDA review, targeting a decision date of August 22, 2026 [2][5] - The company reported significant financial results for the fourth quarter and full year of 2025, including a cash balance of approximately $318 million, which is expected to support operations through 2027 [7][11] Regulatory and Clinical Updates - The FDA is reviewing Capricor's BLA for Deramiocel, classified as a Class 2 resubmission, with the company focusing on execution and preparation for a potential launch [5][6] - The pivotal HOPE-3 Phase 3 trial met its primary endpoint and key secondary cardiac endpoint, demonstrating statistical significance [4][5] - Late-breaking data from the HOPE-3 trial presented at the 2026 MDA Conference highlighted Deramiocel's benefits on cardiac function and disease progression [4][5] Financial Performance - Capricor reported no revenues for the fourth quarter and full year of 2025, a decrease from $11.1 million and $22.3 million in the respective periods of 2024 [8] - Total operating expenses for Q4 2025 were approximately $29.2 million, up from $18.8 million in Q4 2024, with total operating expenses for the year reaching approximately $108.1 million [9] - The net loss for Q4 2025 was approximately $30.2 million, or $0.62 per share, compared to a net loss of $7.1 million, or $0.16 per share, in Q4 2024 [10] Corporate Developments - Capricor's GMP manufacturing facility in San Diego is operational and has completed an FDA Pre-License Inspection, positioning the company for a potential commercial launch [6][4] - The company successfully uplisted to the Nasdaq Global Select Market, enhancing its visibility and access to capital [4][14] - Capricor's balance sheet was strengthened by a public offering that generated approximately $161.9 million in net proceeds [14][7]

Core Insights - Capricor Therapeutics announced new data from the Phase 3 HOPE-3 clinical trial of Deramiocel for Duchenne muscular dystrophy (DMD), highlighting its potential impact on patients' daily lives and long-term outcomes [1][3][5] Company Overview - Capricor Therapeutics is focused on developing cell and exosome-based therapeutics for rare diseases, with Deramiocel as its lead product candidate currently in late-stage development for DMD [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. [9] Clinical Trial Results - The HOPE-3 trial results showed a significant reduction in myocardial fibrosis measured by late gadolinium enhancement (LGE) on cardiac MRI (p=0.022) [6] - In patients with baseline cardiomyopathy, Deramiocel demonstrated a 3.3 percentage-point improvement in left ventricular ejection fraction (LVEF) versus placebo (p=0.017) [6] - The Global Statistical Test (GST) composite endpoint indicated a statistically significant overall treatment benefit favoring Deramiocel (p=0.017) [6] - The Duchenne Video Assessment (DVA) showed approximately 83% slowing of disease progression compared to placebo (p=0.018) [6] Regulatory Status - The Biologics License Application (BLA) for Deramiocel is currently under FDA review, with a target action date of August 22, 2026 [3][5] Collaboration and Commercialization - Capricor has entered into an agreement with Nippon Shinyaku Co., Ltd. for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan, pending regulatory approval [12]