STOCK TITAN

Capricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags

Capricor Therapeutics (NASDAQ: CAPR) reported Q2 2025 financial results and provided key updates on its lead candidate Deramiocel. The company has scheduled a Type A meeting with the FDA to discuss the Deramiocel BLA resubmission path, following a Complete Response Letter. All 483 observations from the Pre-License Inspection have been resolved.

Financial highlights include a cash position of $122.8 million, expected to fund operations into Q4 2026. Q2 2025 resulted in a net loss of $25.9 million ($0.57 per share), compared to $11.0 million in Q2 2024. Operating expenses increased to $27.7 million from $15.6 million year-over-year.

The company's HOPE-3 Phase 3 trial completed its 12-month treatment period with topline data expected in Q4 2025. Additionally, the FDA cleared the IND for StealthX™ exosome-based vaccine, with NIAID initiating the Phase 1 clinical trial.

Capricor Therapeutics (NASDAQ: CAPR) ha comunicato i risultati finanziari del Q2 2025 e ha fornito aggiornamenti sul suo principale candidato, Deramiocel. L'azienda ha programmato un incontro di tipo A con la FDA per discutere la strategia di ripresentazione della BLA di Deramiocel, a seguito di una Complete Response Letter. Tutte le 483 osservazioni emerse durante l'ispezione pre-licenza sono state risolte.

I punti finanziari principali includono una posizione di cassa di $122.8 million, stimata sufficiente a finanziare le operazioni fino al Q4 2026. Il Q2 2025 ha registrato una perdita netta di $25.9 million ($0.57 per azione), rispetto a $11.0 million nel Q2 2024. Le spese operative sono salite a $27.7 million dai $15.6 million dell'anno precedente.

Il trial HOPE-3 di fase 3 ha completato il periodo di trattamento di 12 mesi e i dati topline sono attesi nel Q4 2025. Inoltre, la FDA ha autorizzato l'IND per il vaccino a base di esosomi StealthX™, e il NIAID ha avviato la sperimentazione clinica di fase 1.

Capricor Therapeutics (NASDAQ: CAPR) presentó los resultados financieros del Q2 2025 y ofreció actualizaciones clave sobre su candidato principal, Deramiocel. La compañía ha programado una reunión Tipo A con la FDA para analizar la vía de reenvío de la BLA de Deramiocel tras recibir una Complete Response Letter. Se han resuelto las 483 observaciones de la inspección previa a la concesión de la licencia.

Entre los aspectos financieros destaca una posición de efectivo de $122.8 million, que se espera financie las operaciones hasta el Q4 2026. El Q2 2025 registró una pérdida neta de $25.9 million ($0.57 por acción), frente a $11.0 million en el Q2 2024. Los gastos operativos aumentaron a $27.7 million desde $15.6 million interanual.

El ensayo HOPE-3 de fase 3 completó su periodo de tratamiento de 12 meses y se esperan los datos topline en el Q4 2025. Además, la FDA autorizó el IND para la vacuna basada en exosomas StealthX™, y el NIAID inició el ensayo clínico de fase 1.

Capricor Therapeutics (NASDAQ: CAPR)는 2025년 2분기 실적을 발표하고 주요 후보물질 Deramiocel에 대한 주요 업데이트를 제공했습니다. 회사는 Complete Response Letter 이후 Deramiocel의 BLA 재제출 경로를 논의하기 위해 FDA와의 Type A 회의을 예정했습니다. 사전 허가 검사(Pre-License Inspection)에서 제기된 483건의 지적사항은 모두 해결되었습니다.

재무 하이라이트로는 운영자금을 2026년 4분기까지 지원할 것으로 예상되는 $122.8 million의 현금 보유이 있습니다. 2025년 2분기에는 $25.9 million(주당 $0.57)의 순손실을 기록했으며, 이는 2024년 2분기의 $11.0 million과 비교됩니다. 영업비용은 전년 동기 대비 $27.7 million으로 증가했으며, 이전에는 $15.6 million이었습니다.

회사의 HOPE-3 3상 임상시험은 12개월 치료기간을 마쳤고 톱라인 데이터는 2025년 4분기에 발표될 예정입니다. 또한 FDA는 StealthX™ 외소체(엑소좀) 기반 백신의 IND를 승인했으며, NIAID가 1상 임상시험을 개시했습니다.

Capricor Therapeutics (NASDAQ: CAPR) a publié ses résultats financiers du T2 2025 et a fourni des mises à jour clés sur son candidat principal, Deramiocel. La société a programmé une réunion de type A avec la FDA afin de discuter de la voie de resoumission de la BLA de Deramiocel suite à une Complete Response Letter. Les 483 observations issues de l'inspection pré-licence ont été résolues.

Parmi les points financiers, on relève une trésorerie de $122.8 million, jugée suffisante pour financer les opérations jusqu'au T4 2026. Le T2 2025 s'est soldé par une perte nette de $25.9 million ($0.57 par action), contre $11.0 million au T2 2024. Les dépenses d'exploitation ont augmenté à $27.7 million contre $15.6 million sur un an.

L'essai HOPE-3 de phase 3 a achevé sa période de traitement de 12 mois; les données topline sont attendues au T4 2025. De plus, la FDA a autorisé l'IND pour le vaccin à base d'exosomes StealthX™, et le NIAID a lancé l'essai clinique de phase 1.

Capricor Therapeutics (NASDAQ: CAPR) veröffentlichte die Finanzergebnisse für Q2 2025 und gab wesentliche Updates zu seinem Leitkandidaten Deramiocel bekannt. Das Unternehmen hat ein Type-A-Meeting mit der FDA angesetzt, um den Weg für eine erneute Einreichung der Deramiocel-BLA nach einem Complete Response Letter zu besprechen. Alle 483 Beanstandungen aus der Pre-License Inspection wurden behoben.

Zu den finanziellen Eckdaten zählt eine Barmittelposition von $122.8 million, die voraussichtlich die Geschäftstätigkeit bis Q4 2026 finanziert. Im Q2 2025 wurde ein Nettoverlust von $25.9 million ($0.57 je Aktie) verzeichnet, gegenüber $11.0 million im Q2 2024. Die operativen Aufwendungen stiegen auf $27.7 million von $15.6 million im Jahresvergleich.

Die HOPE-3 Phase-3-Studie hat den 12-monatigen Behandlungszeitraum abgeschlossen; Topline-Daten werden für Q4 2025 erwartet. Zudem hat die FDA das IND für den exosomenbasierten Impfstoff StealthX™ freigegeben, und das NIAID hat die Phase-1-Studie initiiert.

Positive
  • FDA accepted all 483 observations from Pre-License Inspection, confirming manufacturing readiness
  • Strong cash position of $122.8M, funding operations into Q4 2026
  • HOPE-3 Phase 3 trial completed 12-month treatment with data expected Q4 2025
  • FDA cleared IND for StealthX™ exosome-based vaccine platform
  • Received Orphan Drug Designation for Becker muscular dystrophy
  • Four-year HOPE-2 OLE data showed continued preservation of cardiac function
Negative
  • Received Complete Response Letter (CRL) for Deramiocel BLA
  • Net loss increased to $25.9M in Q2 2025 from $11.0M in Q2 2024
  • Operating expenses increased 77.7% to $27.7M year-over-year
  • Zero revenue in Q2 2025 compared to $4.0M in Q2 2024

Insights

Capricor working to overcome regulatory setback for Deramiocel with $123M cash runway through Q4 2026 while advancing exosome platform.

Capricor's Q2 2025 results reveal a company navigating regulatory challenges while maintaining strong financial positioning. The most critical development is the upcoming Type A meeting with the FDA in August to discuss the path forward following the Complete Response Letter (CRL) for Deramiocel's BLA. Management is pursuing approval based on existing HOPE-2 trial data, with HOPE-3 results (expected Q4 2025) potentially serving as supportive evidence.

The FDA's acceptance of all 483 observations from the Pre-License Inspection represents a significant regulatory milestone that resolves manufacturing concerns, removing a major hurdle for eventual approval. This development substantially improves Capricor's commercial readiness position.

Financially, Capricor reports $122.8 million in cash as of June 30, 2025, down from $151.5 million at year-end 2024. The 19% cash reduction reflects increased operating expenses, which rose to $27.7 million in Q2 2025 from $15.6 million in Q2 2024 - primarily driven by R&D costs associated with late-stage clinical development and manufacturing scale-up. The current cash position is expected to fund operations into Q4 2026, providing sufficient runway for key catalysts including HOPE-3 data and potential regulatory resubmission.

Revenue dropped to $0 compared to $4.0 million in Q2 2024 due to the completed recognition of milestone payments from partner Nippon Shinyaku. This explains the widened net loss of $25.9 million ($0.57 per share) versus $11.0 million ($0.35 per share) in Q2 2024.

Beyond Deramiocel, Capricor achieved an important milestone with FDA clearance of the IND for its StealthX™ exosome-based vaccine, now entering Phase 1 trials through NIAID funding. This marks the first clinical validation of their exosome platform technology, potentially opening new therapeutic applications and partnership opportunities.

The orphan drug designation for Deramiocel in Becker muscular dystrophy also expands the company's addressable market beyond Duchenne muscular dystrophy, aligning with their broader neuromuscular disease strategy.

Significant regulatory progress despite BLA setback; FDA acceptance of manufacturing site inspection findings strengthens approval pathway.

Capricor's regulatory position shows both challenges and progress. The Complete Response Letter (CRL) for Deramiocel represents a significant regulatory setback, but the company has secured a critical Type A meeting with the FDA to clarify the path forward. This meeting, scheduled for August 2025, will determine whether Capricor can resubmit its BLA using existing data or must incorporate upcoming HOPE-3 results.

The resolution of all 483 observations from the Pre-License Inspection represents a major regulatory achievement. These manufacturing-related observations are often stumbling blocks in the BLA review process, and their resolution eliminates a significant hurdle to approval. This development suggests that manufacturing concerns were likely not the primary reason for the CRL.

The regulatory strategy appears sound - Capricor aims to leverage the existing HOPE-2 dataset while potentially supplementing with HOPE-3 results as confirmatory evidence. The amendment to the HOPE-3 protocol designating left ventricular ejection fraction (LVEF) as the primary endpoint aligns with the cardiac focus of Deramiocel and may strengthen the regulatory case if needed.

The multiple regulatory designations for Deramiocel - Orphan Drug Designation (both FDA and EMA), Regenerative Medicine Advanced Therapy (RMAT) designation, Advanced Therapy Medicinal Product (ATMP) designation, and Rare Pediatric Disease Designation - provide substantial regulatory advantages including potential Priority Review, expedited review timelines, and possibly a Priority Review Voucher upon approval. The new Orphan Drug Designation for Becker muscular dystrophy further expands these benefits.

The FDA clearance of the IND for the StealthX™ exosome-based vaccine is another regulatory milestone, indicating the agency's willingness to advance Capricor's novel technology platform to human testing. The NIAID's involvement through Project NextGen provides additional regulatory validation and potentially accelerated development.

  • Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approval
  • Capricor seeks to resubmit its BLA based on its existing dataset, with HOPE-3 data (expected in Q4 2025) potentially serving as supportive and confirmatory evidence, pending regulatory guidance
  • All 483 observations noted in the Pre-License Inspection have been resolved and accepted by the FDA
  • FDA clears IND for StealthX™ exosome-based vaccine; NIAID has initiated the Phase 1 clinical trial
  • Cash balance of approximately $123 million expected to support planned operations into the fourth quarter of 2026
  • Capricor will host a conference call and webcast today at 4:30 p.m. ET

SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced its financial results for the second quarter ended June 30, 2025, and provided a corporate update.

“We remain steadfast in our mission to deliver the first approved therapy for Duchenne cardiomyopathy—a serious and progressive complication of DMD with no approved treatments,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “While the receipt of a CRL was a setback, we are working diligently to define a clear regulatory path forward, which has been delineated in our Type A briefing document. Our objective remains to gain approval based on our current Biologics License Application (BLA) submission as expeditiously as possible, with the primary evidence being the totality of data from our HOPE-2 trial and its open-label extension. These results provide a compelling foundation for our submission, and we are fully prepared to supplement the BLA with HOPE-3 data as needed, with topline results expected in the fourth quarter of 2025. Our upcoming Type A meeting with the FDA will be a critical step in outlining the approval pathway. Importantly, the FDA has now accepted all 483 observations noted in our Pre-License Inspection (PLI), marking a major milestone in our regulatory progress and commercial manufacturing readiness. We will share additional updates as they become available, including greater clarity on timelines for potential approval and overall commercial readiness.”

Dr. Marbán continued, “Turning to our other programs, the FDA’s clearance of the IND for StealthX™ marks the first clinical entry for our exosome platform and underscores its potential. While this vaccine trial is a meaningful starting point, our broader goal is to advance StealthX™ into therapeutic applications. Our collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) under Project NextGen reflects our belief in the platform’s potential and may lay the foundation for future strategic partnerships. As we continue to grow this platform, we remain focused on disciplined execution and building long-term value for both patients and shareholders alike.”

Second Quarter 2025 and Recent Highlights

  • Upcoming Type A meeting with U.S. FDA: Capricor will meet with the FDA in August 2025 to discuss next steps following receipt of a Complete Response Letter (CRL) for its BLA for Deramiocel. The Company seeks to resubmit the BLA based on its existing dataset and may include data from the ongoing HOPE-3 trial, pending regulatory guidance.
  • HOPE-3 Phase 3 clinical trial progressing: A protocol amendment has been submitted to designate left ventricular ejection fraction (LVEF) as the primary efficacy endpoint. The study remains fully blinded. The 12-month treatment period in HOPE-3 was recently completed and topline data are expected to be available in the fourth quarter of 2025. Our hope is that these data would serve as supportive and confirmatory evidence for the BLA resubmission, if needed. HOPE-3 is a multi-center, 1:1 randomized, double-blind, placebo-controlled trial enrolling approximately 104 ambulatory and non-ambulatory DMD patients.
  • Pre-License Inspection successfully completed: The FDA has recently accepted all of Capricor’s responses to the 483 observations noted in the PLI, reinforcing Capricor’s readiness for commercial manufacturing and supporting the broader regulatory submission.
  • Positive HOPE-2 OLE data presented at PPMD: Four-year results from the study showed continued preservation of cardiac function (LVEF) and slowed skeletal muscle decline (PUL v2.0) in patients treated with Deramiocel. The therapy continues to show a favorable safety profile through four years of treatment.
  • Orphan Drug Designation granted for Becker muscular dystrophy: The FDA granted Orphan Drug Designation for Deramiocel in Becker muscular dystrophy (BMD), aligning with Capricor’s broader neuromuscular strategy. BMD is a related dystrophinopathy caused by mutations in the same gene as DMD. It typically presents later in life with a slower disease progression and affects an estimated 5,000 individuals in the United States. Despite its milder course, many BMD patients develop serious cardiac complications, including cardiomyopathy, which can significantly affect both quality of life and longevity.
  • StealthX™ platform enters the clinic: The FDA cleared the IND for the StealthX™ exosome-based vaccine, selected for evaluation under Project NextGen—a U.S. Department of Health and Human Services initiative aimed at advancing next-generation vaccines. The Phase 1 clinical trial, conducted and funded by NIAID, was initiated in August 2025, with dosing of the first subject expected imminently. This trial marks the first in human use of Capricor’s exosome platform and sets the stage for future therapeutic development.

Second Quarter 2025 Financial Results

Cash position: Cash, cash equivalents and marketable securities totaled approximately $122.8 million as of June 30, 2025, compared to approximately $151.5 million as of December 31, 2024.

Revenues: Revenues for the second quarter of 2025 were $0, compared to approximately $4.0 million for the second quarter of 2024. Additionally, revenues for the first half of 2025 were $0 compared to approximately $8.9 million for the first half of 2024. Capricor’s primary source of revenue was from the ratable recognition of the $40.0 million (upfront and first development milestone payments from Nippon Shinyaku) and the recognition of the $10.0 million second development milestone payment in accordance with our U.S. Distribution Agreement, both of which were fully recognized as of December 31, 2024.

Costs and Expenses: Total operating expenses for the second quarter of 2025 were approximately $27.7 million compared to approximately $15.6 million for the second quarter of 2024. Total operating expenses for the first half of 2025 were approximately $52.7 million compared to approximately $30.7 million for the first half of 2024.

Net loss: The Company reported a net loss of approximately $25.9 million, or $0.57 per share, for the second quarter of 2025, compared to a net loss of approximately $11.0 million, or $0.35 per share, for the second quarter of 2024. The Company reported a net loss of approximately $50.3 million, or $1.10 per share, for the first half of 2025, compared to a net loss of approximately $20.8 million, or $0.66 per share, for the first half of 2024.

Financial Outlook: The Company believes that based on the current operating plan and financial resources, its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into the fourth quarter of 2026. This expectation excludes any additional potential milestone payments under the Commercialization and Distribution Agreements with Nippon Shinyaku, as well as any strategic use of capital not currently in the Company’s base case planning assumptions.

Upcoming Events

The Company plans to participate at the following upcoming investor events:

  • Cantor Fitzgerald Global Healthcare Conference, September 3-5, 2025, New York, NY
  • 2025 Wells Fargo Healthcare Conference, September 3-5, 2025, Boston, MA
  • H.C. Wainwright Annual Global Investment Conference, September 8-10, 2025, New York, NY
  • Cell & Gene Therapy Meeting on the Mesa 2025, October 6-8, 2025, Phoenix, AZ
  • 4th Annual Roth Healthcare Opportunities Conference, October 9, 2025, New York, NY
  • Maxim Growth Summit, October 22-23, 2025, New York, NY

Conference Call and Webcast

To participate in the conference call, please dial 1-800-717-1738 (Domestic) or 1-646-307-1865 (International) and reference the conference ID: 90328. Participants can use guest dial-in numbers above and be answered by an operator or click the Call me™ link for instant telephone access to the event. To participate via a webcast, please click here. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in dystrophiopathies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing, rather than a pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of Duchenne Muscular Dystrophy (DMD) from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval. For Becker Muscular Dystrophy (BMD), Deramiocel has also received Orphan Drug Designation from the FDA.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Deramiocel, an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown Deramiocel to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. Deramiocel is currently in late-stage development for the treatment of Duchenne Muscular Dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics to potentially treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on FacebookInstagram and Twitter.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission on May 14, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Capricor has entered into an agreement for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204

Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755


CAPRICOR THEAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
        
 Three months ended June 30, Six months ended June 30,
  2025   2024   2025   2024 
        
REVENUE       
Revenue$-  $3,971,438  $-  $8,878,315 
        
TOTAL REVENUE -   3,971,438   -   8,878,315 
        
OPERATING EXPENSES       
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 
        
TOTAL OPERATING EXPENSES 27,719,134   15,562,657   52,702,082   30,735,436 
        
LOSS FROM OPERATIONS (27,719,134)  (11,591,219)  (52,702,082)  (21,857,121)
        
OTHER INCOME (EXPENSE)       
Other income 14,991   -   27,476   - 
Investment income 1,793,352   591,437   2,522,894   1,063,266 
Loss on disposal of fixed assets -   -   (150,673)  - 
        
TOTAL OTHER INCOME (EXPENSE) 1,808,343   591,437   2,399,697   1,063,266 
        
NET LOSS (25,910,791)  (10,999,782)  (50,302,385)  (20,793,855)
        
OTHER COMPREHENSIVE INCOME (LOSS)       
Net unrealized gain (loss) on marketable securities (424,353)  (152,714)  360,619   (80,826)
        
COMPREHENSIVE LOSS$(26,335,144) $(11,152,496) $(49,941,766) $(20,874,681)
        
Net loss per share, basic and diluted$(0.57) $(0.35) $(1.10) $(0.66)
Weighted average number of shares, basic and diluted 45,709,071   31,841,964   45,673,075   31,598,296 
        


CAPRICOR THEAPEUTICS, INC.
SUMMARY BALANCE SHEETS
 
 June 30, 2025
(unaudited)
 December 31, 2024
Cash, cash equivalents and marketable securities$122,800,681  $151,515,877 
Total assets$133,569,011  $170,481,086 
    
Total liabilities$28,591,955  $25,018,750 
    
Total stockholders' equity - 45,711,975 and 45,582,288 common shares issued and   
outstanding at June 30, 2025 and December 31, 2024, respectively 104,977,056   145,462,336 
Total liabilities and stockholders' equity$133,569,011  $170,481,086 
    

FAQ

What were Capricor's (CAPR) key financial results for Q2 2025?

Capricor reported a net loss of $25.9 million ($0.57 per share), cash position of $122.8 million, and operating expenses of $27.7 million. The company had no revenue compared to $4.0 million in Q2 2024.

What is the status of Capricor's Deramiocel BLA submission?

Capricor received a Complete Response Letter and has scheduled a Type A meeting with the FDA in August 2025 to discuss resubmission. All 483 observations from Pre-License Inspection have been resolved.

When will Capricor's HOPE-3 Phase 3 trial results be available?

The HOPE-3 trial has completed its 12-month treatment period and topline data is expected in Q4 2025. The trial enrolled approximately 104 DMD patients.

How long can Capricor's current cash position support operations?

The company's $122.8 million cash position is expected to support operations into the fourth quarter of 2026, excluding potential milestone payments from Nippon Shinyaku.

What progress has Capricor made with its StealthX™ platform?

The FDA cleared the IND for StealthX™ exosome-based vaccine, and NIAID initiated a Phase 1 clinical trial in August 2025, marking the first human use of Capricor's exosome platform.

What were the results from Capricor's HOPE-2 OLE study?

Four-year results showed continued preservation of cardiac function (LVEF) and slowed skeletal muscle decline (PUL v2.0) in Deramiocel-treated patients, with a favorable safety profile.
Capricor Therapeutics Inc

NASDAQ:CAPR

CAPR Rankings

CAPR Latest News

CAPR Latest SEC Filings

CAPR Stock Data

353.78M
38.03M
16.8%
41.05%
21.44%
Biotechnology
Pharmaceutical Preparations
Link
United States
BEVERLY HILLS