Core Points - Rosen Law Firm is reminding investors who purchased Capricor Therapeutics, Inc. securities between October 9, 2024, and July 10, 2025, of the lead plaintiff deadline on September 15, 2025 [1] - Investors may be entitled to compensation through a contingency fee arrangement without any out-of-pocket costs [2] - A class action lawsuit has been filed, and interested parties can join by contacting the firm or visiting their website [3] Case Details - The lawsuit alleges that Capricor provided misleading information regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [5] - Defendants allegedly made positive statements about obtaining a Biologics License Application (BLA) from the FDA while concealing adverse facts about the safety and efficacy data from the Phase 2 HOPE-2 trial [5] - The misleading information is claimed to have caused shareholders to purchase securities at inflated prices, leading to damages when the truth was revealed [5] Rosen Law Firm's Credentials - The firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [4] - Rosen Law Firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time and has recovered hundreds of millions for investors [4] - The firm has been consistently ranked among the top firms for securities class action settlements since 2013 [4]

NEW YORK, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] Pome ...

Core Viewpoint - A class action has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors regarding the viability of its lead product candidate, deramiocel, for treating Duchenne muscular dystrophy (DMD) [1][2]. Group 1: Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for DMD and other diseases with unmet medical needs in the U.S. [1] - The company's lead product candidate is deramiocel, which consists of allogeneic cardiosphere-derived cells [1]. Group 2: Allegations and Legal Action - Robbins LLP is investigating allegations that Capricor misled investors about deramiocel's potential for first approval for DMD cardiomyopathy while concealing adverse facts regarding its safety and efficacy data from the Phase 2 HOPE-2 trial [2]. - The complaint states that the misleading information led to shareholders purchasing Capricor's securities at artificially inflated prices [2]. Group 3: Stock Price Impact - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying its Biologics License Application due to insufficient evidence of effectiveness and the need for additional clinical data [3]. - Following the announcement, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025 [3].

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $122.8 million [23] - Revenues for Q2 2025 were zero, compared to approximately $4 million for Q2 2024, and total revenues for 2025 were zero compared to approximately $8.9 million for 2024 [23][24] - Research and development expenses for Q2 2025 were approximately $20.1 million, up from approximately $11.7 million in Q2 2024, and total R&D expenses for 2025 were approximately $36.3 million compared to approximately $21.8 million for 2024 [25][26] - General and administrative expenses for Q2 2025 were approximately $4 million, compared to approximately $1.8 million in Q2 2024, and total G&A expenses for 2025 were approximately $7 million compared to approximately $3.6 million for 2024 [26] - The net loss for Q2 2025 was approximately $25.9 million, compared to a net loss of approximately $11 million for Q2 2024, and the total net loss for 2025 was approximately $50.3 million compared to approximately $20.8 million for 2024 [26] Business Line Data and Key Metrics Changes - The company is focused on advancing daramycin for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy, which is a significant unmet need in the DMD community [5][6] - The HOPE-three trial is fully enrolled with 104 patients, and the primary efficacy endpoint has been amended to Left Ventricular Ejection Fraction (LVEF) [9][10] Market Data and Key Metrics Changes - The company is actively working with the FDA to clarify the path forward for daramycin following a complete response letter received in July 2025 [6][12] - The company is also involved in Project NextGen, focusing on advancing next-generation vaccines for COVID-19 and other infectious diseases through its Stealth X vaccine [17][18] Company Strategy and Development Direction - The company aims to deliver transformative therapies for rare diseases, with a strong commitment to the DMD community [5] - The strategy includes working constructively with the FDA to define a clear path for daramycin's approval and preparing for potential commercial launch activities [8][16] - The company is also exploring opportunities in vaccine development through its exosome platform, which could lead to partnerships and expansion into other therapeutic areas [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their data and the potential for daramycin to stabilize cardiac function in DMD patients [14][29] - The company remains focused on regulatory clarity and is optimistic about the upcoming Type A meeting with the FDA [35][64] - Management emphasized the importance of LVEF as a primary efficacy endpoint and the need for innovative thinking from the FDA regarding rare disease approvals [82][87] Other Important Information - The company has received formal acceptance of all items from its pre-license inspection, validating its quality systems and manufacturing capabilities [14][15] - The company is well-positioned financially, with over $120 million in cash, allowing it to support operations until late 2026 [28] Q&A Session Summary Question: What is the plan for unblinding the HOPE-three trial? - The company is waiting for FDA adjudication on requirements for HOPE-three before proceeding with unblinding [33] Question: What incremental data could be submitted to the FDA? - The company is considering submitting supplemental open-label extension data to support safety and efficacy [41] Question: How has the FDA review team changed? - The company is uncertain about changes in the review team but is looking forward to working with the FDA [111] Question: What are the key takeaways expected from the upcoming Type A meeting? - The company aims to clarify what is required for approval and the primary endpoint for HOPE-three [64] Question: What accounts for the increase in R&D expenses? - The increase is due to ongoing clinical studies and preparations for CMC endeavors [105]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The financial statements for the period ended June 30, 2025, reflect a significant increase in net loss, no revenue, and a strong cash position of **$122.8 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,241,199 | $11,286,996 | | Marketable securities | $99,559,482 | $140,228,881 | | **Total Assets** | **$133,569,011** | **$170,481,086** | | **Total Liabilities** | **$28,591,955** | **$25,018,750** | | **Total Stockholders' Equity** | **$104,977,056** | **$145,462,336** | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $0 | $3,971,438 | $0 | $8,878,315 | | Research and development | $22,047,254 | $12,504,769 | $40,962,826 | $23,605,782 | | General and administrative | $5,671,880 | $3,057,888 | $11,739,256 | $7,129,654 | | **Net Loss** | **($25,910,791)** | **($10,999,782)** | **($50,302,385)** | **($20,793,855)** | | Net loss per share | ($0.57) | ($0.35) | ($1.10) | ($0.66) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($26,555,731) | ($13,556,939) | | Net cash provided by investing activities | $38,440,000 | $5,193,130 | | Net cash provided by financing activities | $69,934 | $4,357,315 | | **Net increase (decrease) in cash** | **$11,954,203** | **($4,006,494)** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the FDA's **Complete Response Letter** for deramiocel, ongoing HOPE-3 trial, and the exosome platform, while reporting a **$50.3 million** net loss and **$122.8 million** in liquidity - In **July 2025**, the company received a **Complete Response Letter (CRL)** from the FDA for its deramiocel BLA, stating that the application did not meet the requirement for substantial evidence of effectiveness and required **additional clinical data**. A Type A meeting with the FDA is scheduled for August 2025[159](index=159&type=chunk)[160](index=160&type=chunk) - The company expects to report topline results from its ongoing **Phase 3 HOPE-3 clinical trial** in the **fourth quarter of 2025**. The study protocol was amended to designate **left ventricular ejection fraction (LVEF)** as the primary endpoint to focus on cardiac efficacy, in alignment with FDA feedback[164](index=164&type=chunk) - As of June 30, 2025, the company had approximately **$122.8 million** in cash, cash equivalents, and marketable securities. Management estimates these funds are sufficient to support operations and capital expenditures into the **fourth quarter of 2026**[173](index=173&type=chunk)[197](index=197&type=chunk) Financial Performance Summary (Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $0 | $8.9 million | | R&D Expenses | $41.0 million | $23.6 million | | G&A Expenses | $11.7 million | $7.1 million | | Net Loss | ($50.3 million) | ($20.8 million) | [Company Overview and Product Pipeline](index=39&type=section&id=Company%20Overview%20and%20Product%20Pipeline) Capricor, a clinical-stage biotech, focuses on cell and exosome therapies, with lead candidate deramiocel receiving an FDA CRL and StealthX™ entering Phase 1 trials - The company's lead program, **deramiocel**, is an **allogeneic cell therapy** for treating cardiomyopathy in **DMD patients**. Its therapeutic effect is primarily mediated by secreted exosomes that are immunomodulatory, anti-inflammatory, and anti-fibrotic[155](index=155&type=chunk) - Following a rolling BLA submission in December 2024, the FDA granted Priority Review but later issued a **CRL** in **July 2025**, requesting **additional clinical data** to demonstrate substantial evidence of effectiveness[157](index=157&type=chunk)[159](index=159&type=chunk) - The company's **StealthX™ exosome platform** is being developed for vaccines and other therapies. A **Phase 1 trial** for its COVID-19 vaccine, sponsored by NIAID under Project NextGen, initiated in **August 2025**[170](index=170&type=chunk)[171](index=171&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) The company reported no revenue for Q2 2025, with R&D expenses increasing **76%** to **$22.0 million** and G&A expenses rising **85%** to **$5.7 million** due to higher operational costs - The company recognized **no clinical development income** in Q2 2025, as the **$50.0 million** in development milestone payments from the U.S. Distribution Agreement with Nippon Shinyaku had been fully recognized by the end of 2024[180](index=180&type=chunk) Research & Development Expenses Breakdown (Three Months Ended June 30) | Category | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Compensation & personnel | $7,510,545 | $3,596,825 | 109% | | DMD program (deramiocel) | $9,838,927 | $5,965,495 | 65% | | Stock-based compensation | $1,930,467 | $852,472 | 126% | | **Total R&D Expenses** | **$22,047,254** | **$12,504,769** | **76%** | General & Administrative Expenses Breakdown (Three Months Ended June 30) | Category | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Compensation & personnel | $2,139,615 | $837,474 | 155% | | Stock-based compensation | $1,716,687 | $1,300,321 | 32% | | Other corporate expenses | $1,043,895 | $328,363 | 218% | | **Total G&A Expenses** | **$5,671,880** | **$3,057,888** | **85%** | [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) Capricor held **$122.8 million** in liquidity as of June 30, 2025, projected to fund operations into **Q4 2026**, despite increased cash usage in operating activities Liquidity and Capital Resources Summary (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,241 | $11,287 | | Marketable securities | $99,559 | $140,229 | | Working capital | $95,729 | $142,359 | - Cash used in operating activities increased to **$26.6 million** for the six months ended June 30, 2025, compared to **$13.6 million** for the same period in 2024, primarily due to a higher net loss[201](index=201&type=chunk) - In February 2025, the company elected to convert its approximately **$3.4 million** CIRM grant award into a loan. The terms are under discussion, and accrued interest could reach up to approximately **$7.1 million**[220](index=220&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=64&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risk primarily stems from interest rate sensitivity on its **$122.8 million** cash and marketable securities portfolio, with minimal impact from rate changes due to short-term investments - The company's market risk is primarily from interest rate sensitivity on its **$122.8 million** portfolio of cash, cash equivalents, and marketable securities[248](index=248&type=chunk) - The investment policy focuses on **high credit quality issuers** and **short-term maturities** to mitigate default and market risk. The company does not currently hedge interest rate exposure[249](index=249&type=chunk) [Item 4. Controls and Procedures](index=66&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were **effective** at the **reasonable assurance level**[251](index=251&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the quarter ended June 30, 2025[252](index=252&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=67&type=section&id=Item%201.%20Legal%20Proceedings) The company faces new legal challenges, including a securities class action filed July 17, 2025, and a derivative action filed August 1, 2025, both alleging federal securities law violations or fiduciary duty breaches - A putative **securities class action** was filed on **July 17, 2025**, against the company and its CEO, alleging violations of U.S. federal securities laws[255](index=255&type=chunk) - A **derivative action** was filed on **August 1, 2025**, against the company's Board of Directors, alleging breaches of fiduciary duties[256](index=256&type=chunk) [Item 1A. Risk Factors](index=67&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the potential for significant costs and management distraction from recently filed securities class action and derivative lawsuits, which could harm the business - A new risk factor has been identified concerning the costs and management distraction associated with defending against the recently filed **securities class action** and **derivative claims**[258](index=258&type=chunk) [Item 5. Other Information](index=67&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the second quarter of 2025 - No directors or executive officers adopted or terminated any **Rule 10b5-1 trading arrangements** during the three months ended June 30, 2025[262](index=262&type=chunk)

Corporate Update and Recent Highlights The company advanced its Deramiocel regulatory path, initiated clinical trials for its StealthX™ platform, and achieved commercial manufacturing readiness [Deramiocel Program Update](index=1&type=section&id=Deramiocel%20Program%20Update) The company is advancing the regulatory pathway for Deramiocel with the FDA while reporting positive long-term clinical data - **A Type A meeting with the U.S. FDA is scheduled for August 2025** to discuss the Deramiocel BLA path forward after receiving a Complete Response Letter (CRL)[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The company aims to resubmit the BLA based on HOPE-2 data, with **HOPE-3 topline data expected in Q4 2025** as potential support[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - **Four-year HOPE-2 extension data showed continued preservation of cardiac function** (LVEF) and slowed skeletal muscle decline in patients treated with Deramiocel[7](index=7&type=chunk) - The FDA granted **Orphan Drug Designation for Deramiocel in Becker muscular dystrophy** (BMD)[13](index=13&type=chunk) [StealthX™ Platform Update](index=1&type=section&id=StealthX%E2%84%A2%20Platform%20Update) The StealthX™ exosome platform entered the clinical stage with FDA clearance and the initiation of a Phase 1 vaccine trial - **The FDA cleared the IND for the StealthX™ exosome-based vaccine**, marking its first-in-human use[3](index=3&type=chunk)[5](index=5&type=chunk)[13](index=13&type=chunk) - A **Phase 1 clinical trial was initiated in August 2025**, conducted and funded by NIAID as part of the Project NextGen initiative[3](index=3&type=chunk)[13](index=13&type=chunk) [Manufacturing and Commercial Readiness](index=1&type=section&id=Manufacturing%20and%20Commercial%20Readiness) Capricor successfully resolved all FDA Pre-License Inspection observations, confirming its commercial manufacturing readiness - **All 483 Pre-License Inspection observations have been resolved and accepted by the FDA**, a key manufacturing milestone[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) Second Quarter 2025 Financial Results The company reported zero revenue and a wider net loss for Q2 2025, while maintaining a cash runway into late 2026 [Key Financial Metrics](index=3&type=section&id=Key%20Financial%20Metrics) The company reported zero revenue and a wider net loss in Q2 2025 due to increased operating expenses and prior milestone recognition Quarterly Financial Performance | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $0 | $4.0M | -100% | | Total Operating Expenses | $27.7M | $15.6M | +77.8% | | Net Loss | ($25.9M) | ($11.0M) | +135.5% | | Net Loss Per Share | ($0.57) | ($0.35) | +62.9% | Half-Year Financial Performance | Financial Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $0 | $8.9M | -100% | | Total Operating Expenses | $52.7M | $30.7M | +71.6% | | Net Loss | ($50.3M) | ($20.8M) | +141.9% | | Net Loss Per Share | ($1.10) | ($0.66) | +66.7% | [Financial Position and Outlook](index=3&type=section&id=Financial%20Position%20and%20Outlook) The company holds a strong cash position of $122.8 million, sufficient to fund operations into the fourth quarter of 2026 - **Cash and equivalents totaled $122.8 million** as of June 30, 2025, compared to $151.5 million at year-end 2024[8](index=8&type=chunk) - The current cash balance is expected to **fund operations into the fourth quarter of 2026**[5](index=5&type=chunk)[12](index=12&type=chunk) Company and Product Information This section details the company's focus on rare disease therapeutics, its lead candidate Deramiocel, and its StealthX™ platform [About Deramiocel (CAP-1002)](index=5&type=section&id=About%20Deramiocel) Deramiocel is an allogeneic cell therapy for dystrophinopathies that has received multiple special regulatory designations - Deramiocel is an allogeneic cardiosphere-derived cell (CDC) therapy with **immunomodulatory and anti-fibrotic actions**[17](index=17&type=chunk) - The therapy holds multiple key regulatory designations, including **Orphan Drug, RMAT, and Rare Pediatric Disease designations**[18](index=18&type=chunk) [About Capricor Therapeutics](index=5&type=section&id=About%20Capricor%20Therapeutics) Capricor Therapeutics is a biotechnology company developing cell and exosome-based therapies for rare diseases - Capricor is a biotechnology company focused on **cell and exosome-based therapeutics for rare diseases**[19](index=19&type=chunk) - The company's pipeline is led by **Deramiocel for DMD** and the **StealthX™ exosome platform** for vaccines and targeted delivery[19](index=19&type=chunk) Financial Statements This section presents the company's unaudited consolidated statements of operations and summary balance sheets for the period [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) The statement of operations shows zero revenue and a higher net loss for the three and six months ended June 30, 2025 Unaudited Consolidated Statements of Operations and Comprehensive Loss | (In thousands, except per share data) | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue** | **$0** | **$3,971** | **$0** | **$8,878** | | **Operating Expenses** | | | | | | Research and development | $22,047 | $12,505 | $40,963 | $23,606 | | General and administrative | $5,672 | $3,058 | $11,739 | $7,130 | | **Total Operating Expenses** | **$27,719** | **$15,563** | **$52,702** | **$30,735** | | **Loss from Operations** | **($27,719)** | **($11,591)** | **($52,702)** | **($21,857)** | | **Net Loss** | **($25,911)** | **($11,000)** | **($50,302)** | **($20,794)** | | **Net Loss Per Share** | **($0.57)** | **($0.35)** | **($1.10)** | **($0.66)** | [Summary Balance Sheets](index=8&type=section&id=SUMMARY%20BALANCE%20SHEETS) The balance sheet reflects a decrease in cash and total assets, resulting in lower stockholders' equity as of June 30, 2025 Unaudited Summary Balance Sheets | (In thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $122,801 | $151,516 | | **Total Assets** | **$133,569** | **$170,481** | | **Total Liabilities** | **$28,592** | **$25,019** | | **Total Stockholders' Equity** | **$104,977** | **$145,462** | | **Total Liabilities and Stockholders' Equity** | **$133,569** | **$170,481** |

Core Insights - Capricor Therapeutics is focused on developing therapies for Duchenne cardiomyopathy and has faced regulatory challenges but is working on a clear path forward for approval [2][4] - The company has made significant progress with its exosome platform, StealthX™, which has received FDA clearance for clinical trials [4][6] - Financial results indicate a net loss for the second quarter of 2025, with revenues dropping to zero compared to the previous year [8][10] Corporate Update - Capricor aims to resubmit its Biologics License Application (BLA) for Deramiocel based on existing data, with additional data from the HOPE-3 trial expected in Q4 2025 [4][5] - The FDA has accepted all observations from the Pre-License Inspection, marking a milestone in regulatory progress [4][5] - The company is preparing for a Type A meeting with the FDA to discuss the approval pathway [4][5] Financial Performance - Cash position as of June 30, 2025, was approximately $122.8 million, down from $151.5 million at the end of 2024 [7][26] - Revenues for Q2 2025 were $0, a decrease from approximately $4.0 million in Q2 2024, and for the first half of 2025, revenues were also $0 compared to approximately $8.9 million in the first half of 2024 [8][10] - Total operating expenses for Q2 2025 were approximately $27.7 million, up from $15.6 million in Q2 2024 [9][10] Clinical Development - The HOPE-3 Phase 3 clinical trial is ongoing, with topline data expected in Q4 2025 [5][6] - The FDA has cleared the IND for the StealthX™ exosome-based vaccine, marking its first clinical entry [4][6] - Orphan Drug Designation has been granted for Deramiocel in Becker muscular dystrophy, expanding its therapeutic strategy [5][6]

DEADLINE: September 15, 2025 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/capricor-loss-submission-form/? id=160430&from=4 NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of CAPR during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead p ...

Core Viewpoint - The complaint alleges that Capricor and its executives violated federal securities laws by making false or misleading statements regarding the drug deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2] Group 1: Company Conduct - Capricor allegedly provided investors with overly positive statements about its ability to obtain a Biologics License Application (BLA) from the FDA while concealing adverse facts related to the safety and efficacy data from its Phase 2 HOPE-2 trial [2] - On July 11, 2025, Capricor received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and the need for additional clinical data [3] Group 2: Market Reaction - Following the announcement of the CRL, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, reflecting a significant decline in investor confidence [4]

Core Viewpoint - Capricor Therapeutics is advancing its lead cell therapy candidate, Deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) and has scheduled a Type A meeting with the FDA to discuss its regulatory path for the Biologics License Application (BLA) [1][4][7] Financial Results and Corporate Update - The release of Capricor's financial results for the second quarter ended June 30, 2025, has been rescheduled to August 11, 2025, after market close [2][3] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to review the financial results and provide a corporate update [2][3] Company Overview - Capricor Therapeutics focuses on developing cell and exosome-based therapeutics for rare diseases, with Deramiocel being a key product candidate showing immunomodulatory and anti-fibrotic effects in muscular dystrophies [4] - The company is also utilizing its proprietary StealthX™ platform for preclinical development in areas such as vaccinology and targeted delivery of therapeutics [4] Commercialization Agreement - Capricor has entered into an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of Deramiocel for DMD in the United States and Japan, pending regulatory approval [7]