Capricor Therapeutics Signs Binding Term Sheet with Nippon Shinyaku for European Expansion and Commercialization of Deramiocel for the Treatment of Duchenne Muscular Dystrophy
Capricor Therapeutics (NASDAQ: CAPR) has entered a binding term sheet with Nippon Shinyaku for the commercialization and distribution of deramiocel in Europe for treating Duchenne muscular dystrophy (DMD). The deal includes a $15 million equity investment at a 20% premium and a $20 million upfront payment upon signing the definitive agreement. Potential milestones could reach $715 million, with Capricor receiving a double-digit percentage of product revenue. This extends Capricor's cash runway into 2026 and brings the total potential milestones from combined distribution agreements to approximately $1.5 billion. Capricor will handle development and manufacturing, while Nippon Shinyaku will manage sales and distribution in Europe.
Capricor Therapeutics (NASDAQ: CAPR) ha stipulato un accordo vincolante con Nippon Shinyaku per la commercializzazione e distribuzione di deramiocel in Europa per il trattamento della distrofia muscolare di Duchenne (DMD). L'accordo prevede un investimento azionario di 15 milioni di dollari con un premio del 20% e un pagamento iniziale di 20 milioni di dollari al momento della firma dell'accordo definitivo. I traguardi potenziali potrebbero raggiungere 715 milioni di dollari, con Capricor che riceverà una percentuale a doppia cifra delle entrate del prodotto. Questo estende la disponibilità di liquidità di Capricor fino al 2026 e porta il totale dei potenziali traguardi derivanti dagli accordi di distribuzione combinati a circa 1,5 miliardi di dollari. Capricor si occuperà dello sviluppo e della produzione, mentre Nippon Shinyaku gestirà le vendite e la distribuzione in Europa.
Capricor Therapeutics (NASDAQ: CAPR) ha firmado un acuerdo vinculante con Nippon Shinyaku para la comercialización y distribución de deramiocel en Europa para el tratamiento de la distrofia muscular de Duchenne (DMD). El acuerdo incluye una inversión de capital de 15 millones de dólares con una prima del 20% y un pago inicial de 20 millones de dólares al firmar el acuerdo definitivo. Las metas potenciales podrían alcanzar 715 millones de dólares, con Capricor recibiendo un porcentaje de dos dígitos de los ingresos del producto. Esto extiende el tiempo de financiación de Capricor hasta 2026 y lleva el total de las metas potenciales de los acuerdos de distribución combinados a aproximadamente 1.5 mil millones de dólares. Capricor se encargará del desarrollo y la fabricación, mientras que Nippon Shinyaku gestionará las ventas y la distribución en Europa.
Capricor Therapeutics (NASDAQ: CAPR)는 Duchenne 근육형성위축증 (DMD) 치료를 위해 유럽에서 deramiocel의 상업화 및 유통을 위해 Nippon Shinyaku와 구속력 있는 계약을 체결했습니다. 이 거래에는 1500만 달러의 지분 투자와 20% 프리미엄에 2000만 달러의 계약 체결 시 선불금이 포함됩니다. 잠재적 마일스톤은 총 7억 1500만 달러에 이를 수 있으며, Capricor는 제품 수익의 두 자릿수 비율을 받을 것입니다. 이는 Capricor의 자금 조달 가능성을 2026년까지 연장하며, 결합된 유통 계약에서 발생할 수 있는 총 잠재적 마일스톤은 약 15억 달러에 달합니다. Capricor는 개발 및 제조를 담당하고, Nippon Shinyaku는 유럽 내 판매 및 유통을 관리할 것입니다.
Capricor Therapeutics (NASDAQ: CAPR) a signé une feuille de termes contraignante avec Nippon Shinyaku pour la commercialisation et distribution de deramiocel en Europe pour le traitement de la dystrophie musculaire de Duchenne (DMD). L'accord inclut un investissement en actions de 15 millions de dollars avec une prime de 20% et un paiement initial de 20 millions de dollars lors de la signature de l'accord définitif. Les jalons potentiels pourraient atteindre 715 millions de dollars, Capricor recevant un pourcentage à deux chiffres des revenus du produit. Cela prolonge la trésorerie de Capricor jusqu'en 2026 et porte le total des jalons potentiels des accords de distribution combinés à environ 1,5 milliard de dollars. Capricor s'occupera du développement et de la fabrication, tandis que Nippon Shinyaku gérera les ventes et la distribution en Europe.
Capricor Therapeutics (NASDAQ: CAPR) hat ein verbindliches Vertragsangebot mit Nippon Shinyaku zur Kommerzialisierung und Distribution von deramiocel in Europa zur Behandlung der Duchenne-Muskeldystrophie (DMD) unterzeichnet. Der Vertrag umfasst eine Aktieninvestition von 15 Millionen Dollar mit einem Aufschlag von 20% und einer Vorauszahlung von 20 Millionen Dollar bei Unterzeichnung des endgültigen Vertrags. Mögliche Meilensteine könnten 715 Millionen Dollar erreichen, wobei Capricor einen Prozentsatz im zweistelligen Bereich vom Produktumsatz erhält. Dadurch wird die finanzielle Laufzeit von Capricor bis 2026 verlängert und die Gesamtsumme der potenziellen Meilensteine aus den kombinierten Vertriebsvereinbarungen auf etwa 1,5 Milliarden Dollar erhöht. Capricor wird das Entwicklung und die Herstellung übernehmen, während Nippon Shinyaku den Verkauf und die Distribution in Europa verwaltet.
- $15 million equity investment at 20% premium
- $20 million upfront payment upon signing definitive agreement
- Potential milestones of up to $715 million
- Double-digit percentage share of product revenue
- Cash runway extended into 2026
- Total potential milestones from combined agreements reach $1.5 billion
- Expansion of deramiocel commercialization into European market
- None.
Insights
This partnership expansion marks a significant milestone for Capricor Therapeutics in their quest to bring deramiocel to DMD patients globally. The
The potential
The deal structure is highly favorable for Capricor. The
The extended cash runway into 2026 provides a substantial financial cushion, reducing near-term funding risks. With potential milestones now totaling approximately
This expansion into Europe is a strategic move for both Capricor and Nippon Shinyaku in the Duchenne muscular dystrophy (DMD) market. DMD, affecting approximately 1 in 3,500 male births worldwide, has treatment options, creating a significant unmet medical need. Deramiocel's potential to address this need could lead to rapid market adoption if approved.
The partnership leverages Nippon Shinyaku's established presence in rare diseases, potentially accelerating market penetration in Europe. However, competition from other emerging therapies and the challenges of navigating different European healthcare systems could impact the commercial success. The upcoming meeting with EMA will be crucial in determining the regulatory pathway and timeline for potential European approval.
-Capricor to Receive
-Upfront Payment and Investment Extends Cash Runway into 2026-
-Potential Milestones from Combined Distribution Agreements Now Total approximately
-Capricor Preparing to Meet with EMA to Discuss European Expansion for Deramiocel-
SAN DIEGO, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced it has entered into a binding term sheet with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company listed on the TYO, for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. The potential transaction covered by the term sheet is similar to the existing Commercialization and Distribution Agreements with Nippon Shinyaku in the United States and Japan with an opportunity for further product reach globally. In addition, Nippon Shinyaku has agreed to purchase approximately
Under the terms of the binding term sheet and further subject to finalization of a Definitive Agreement, which is expected to occur in the fourth quarter of 2024, Capricor will be responsible for the development and manufacturing of deramiocel for potential approval in all countries in the European Union, United Kingdom and several other countries in the region. Nippon Shinyaku will be responsible for the sales and distribution of deramiocel in those territories. Capricor will also receive an upfront payment of
“Our expanded partnership with Nippon Shinyaku into the European region marks a pivotal moment for Capricor as we work together to bring deramiocel to DMD patients worldwide,” said Linda Marbán, Ph.D., Capricor’s Chief Executive Officer. “With the addition of the upfront payment and equity investment, we will be able to extend our runway into 2026 and be well positioned to advance toward potential approval of deramiocel in the United States and beyond. Furthermore, these funds will provide necessary capital for commercial launch preparations, manufacturing scale-up and product development for Europe, as we envision high global demand for deramiocel.”
Dr. Marbán continued, “As previously reported, we held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in August. Since that meeting, we have now had several additional informal meetings with the agency to continue to refine our approval pathway for deramiocel in the United States and we plan to provide further updates as they become available.”
Toru Nakai, President of Nippon Shinyaku, commented, “We look forward to building deramiocel’s commercial footprint around the world and this partnership would allow us to continue to invest in Nippon Shinyaku’s DMD franchise and to potentially advance life-changing therapies for patients in need.”
Contemporaneously with the term sheet, Nippon Shinyaku has also agreed to purchase 2,798,507 shares of common stock at a price of
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a registration statement with the Securities and Exchange Commission for purposes of registering the resale by the investors of the shares of common stock purchased by such investors.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offering of the securities under the resale registration statement will only be by means of a prospectus.
About Deramiocel (CAP-1002)
Deramiocel consists of allogeneic cardiosphere-derived cells (CDCs), a population of stromal cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory, antifibrotic and regenerative actions in dystrophinopathy and heart failure. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile so that they adopt a healing, rather than a pro-inflammatory, phenotype. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 200 human subjects across several clinical trials. Deramiocel for the treatment of DMD has received Orphan Drug Designation and the regulatory pathway for deramiocel is supported by RMAT (Regenerative Medicine Advanced Therapy Designation). In addition, if Capricor were to receive FDA marketing approval for deramiocel for the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (PRV) based on its previous receipt of a rare pediatric disease designation.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years. It is estimated that DMD occurs in approximately one in every 3,500 male births and that the patient population is estimated to be approximately 15,000-20,000 in the United States. DMD pathophysiology is driven by the impaired production of functional dystrophin, which normally functions as a structural protein in muscle. The reduction of functional dystrophin in muscle cells leads to significant cell damage and ultimately causes muscle cell death and fibrotic replacement. Treatment options are limited and there is no cure.
About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (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 (CAP-1002), an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown deramiocel to demonstrate immunomodulatory, antifibrotic, and regenerative actions specifically tailored for dystrophinopathies and heart disease. Deramiocel is currently advancing through Phase 3 clinical 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 Facebook, Instagram 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 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, 2023, as filed with the Securities and Exchange Commission on March 11, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on August 8, 2024. 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 (CAP-1002) for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.
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
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