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BrainStorm Strengthens Exosome Patent Portfolio: Receives Notice of Allowance for U.S. Patent Covering Its Platform Technology

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BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received a Notice of Allowance from the USPTO for patent application 16/981,757, covering its proprietary exosome technology. The patent protects the composition and method of unique exosomes isolated from MSC-NTF cells, containing specific neurotrophic factors (LIF, VEGFA, GDF-15) and potentially additional proteins or microRNA molecules. The patent is expected to provide protection until April 10, 2039. The company aims to strengthen its position in cellular and exosome-based therapies while focusing on NurOwn development for ALS through an upcoming Phase 3b registrational trial.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) ha ricevuto un Avviso di Concessione dal USPTO per la domanda di brevetto 16/981,757, riguardante la sua tecnologia proprietaria degli esosomi. Il brevetto protegge la composizione e il metodo di esosomi unici isolati dalle cellule MSC-NTF, contenenti fattori neurotrofici specifici (LIF, VEGFA, GDF-15) e eventualmente ulteriori proteine o molecole di microRNA. Il brevetto dovrebbe fornire protezione fino al 10 aprile 2039. L'azienda punta a rafforzare la sua posizione nelle terapie cellulari e basate sugli esosomi, concentrandosi nello sviluppo di NurOwn per la SLA attraverso un imminente trial registrativo di Fase 3b.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) ha recibido un Aviso de Concesión de la USPTO para la solicitud de patente 16/981,757, que cubre su tecnología exclusiva de exosomas. La patente protege la composición y el método de exosomas únicos aislados de células MSC-NTF, que contienen factores neurotróficos específicos (LIF, VEGFA, GDF-15) y potencialmente proteínas adicionales o moléculas de microARN. Se espera que la patente brinde protección hasta el 10 de abril de 2039. La empresa tiene como objetivo fortalecer su posición en terapias celulares y basadas en exosomas mientras se centra en el desarrollo de NurOwn para la ELA a través de un próximo ensayo registrativo de Fase 3b.

BrainStorm Cell Therapeutics (NASDAQ: BCLI)는 USPTO로부터 16/981,757 특허 신청에 대한 허가 통지를 받았습니다. 이는 그들의 독점적인 엑소좀 기술을 다루고 있습니다. 해당 특허는 특정 신경영양인자(LIF, VEGFA, GDF-15)를 포함하고 추가적인 단백질이나 마이크로RNA 분자가 포함될 수 있는 MSC-NTF 세포에서 분리된 독특한 엑소좀의 구성과 방법을 보호합니다. 이 특허는 2039년 4월 10일까지 보호를 제공할 것으로 예상됩니다. 이 회사는 세포 및 엑소좀 기반 치료에서의 입지를 강화하며, 다가오는 3b상 등록시험을 통해 ALS를 위한 NurOwn 개발에 집중할 계획입니다.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) a reçu un Avis de Concession de l'USPTO pour la demande de brevet 16/981,757, couvrant sa technologie exclusive d'exosomes. Le brevet protège la composition et la méthode d'exosomes uniques isolés à partir de cellules MSC-NTF, contenant des facteurs neurotrophiques spécifiques (LIF, VEGFA, GDF-15) et potentiellement d'autres protéines ou molécules de microARN. On s'attend à ce que le brevet offre une protection jusqu'au 10 avril 2039. L'entreprise vise à renforcer sa position dans les thérapies cellulaires et basées sur les exosomes tout en se concentrant sur le développement de NurOwn pour la SLA à travers un prochain essai d'enregistrement de phase 3b.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) hat eine Aufforderung zur Erteilung von einem USPTO für die Patentanmeldung 16/981,757 erhalten, die sich auf ihre proprietäre Exosom-Technologie bezieht. Das Patent schützt die Zusammensetzung und das Verfahren einzigartiger Exosomen, die aus MSC-NTF-Zellen isoliert sind und spezifische neurotrophe Faktoren (LIF, VEGFA, GDF-15) sowie möglicherweise zusätzliche Proteine oder MikroRNA-Moleküle enthalten. Es wird erwartet, dass das Patent bis zum 10. April 2039 Schutz bietet. Das Unternehmen beabsichtigt, seine Position in zellulären und auf Exosomen basierenden Therapien zu stärken, während es sich auf die Entwicklung von NurOwn für ALS durch eine bevorstehende Registierungsstudie der Phase 3b konzentriert.

Positive
  • Patent protection secured until 2039 for proprietary exosome technology
  • Strengthened intellectual property portfolio in cellular and exosome-based therapies
Negative
  • None.

Insights

This patent allowance significantly strengthens BrainStorm's intellectual property position in the competitive exosome therapeutics space. The patent's scope is notably comprehensive, covering both composition and method claims for MSC-NTF-derived exosomes until 2039. The inclusion of specific neurotrophic factors (LIF, VEGFA, GDF-15) in the claims provides robust protection for the company's unique bioreactor-produced exosomes.

However, the commercial value of this patent remains speculative. While it adds to BrainStorm's IP portfolio, the company's $9.8M market cap and focus on NurOwn for ALS suggests this technology may require substantial additional development or partnership arrangements to generate meaningful revenue. The patent's defensive value in preventing competitors from entering this specific technical space may be its primary near-term benefit.

NEW YORK, Dec. 3, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it has received Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) for patent application 16/981,757 which covers its proprietary exosome technology. 

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The patent describes the composition and method of BrainStorm's unique exosomes that are isolated from the secretome of MSC-NTF (mesenchymal stem cells that secrete neurotrophic factors). MSC-NTF -derived exosomes are produced in bioreactors and contain cargo (i.e. active biological molecules) that includes at least one of the following neurotrophic factors (LIF, VEGFA, GDF-15), and may contain additional proteins or microRNA molecules. The exosomes express characteristic exosomal and MSC markers and are isolated in a unique process developed by BrainStorm and comprise a proprietary product. This patent enhances BrainStorm's exosome intellectual property portfolio, further strengthening the company's position as a leader in developing cutting-edge cellular and exosome-based therapies. It is expected to provide protection until April 10, 2039, subject to standard term adjustments.

"This patent strengthens BrainStorm's intellectual property portfolio and highlights our commitment to advancing novel technologies for respiratory and neurodegenerative diseases," said Chaim Lebovits, BrainStorm's President and Chief Executive Officer. "Our primary focus continues to be development of NurOwn for ALS as we prepare to initiate a Phase 3b registrational trial.  We are seeking additional ways to unlock value from our assets and are pursuing strategic collaborations for the exosome platform."

About BrainStorm's Exosome Technology

Exosomes are nano-sized (typically 30–120 nm), cell-derived extracellular vesicles, naturally released by cells, that play a role in intercellular communication and the transport of biological materials. Exosomal cargo provides important regulatory functions for many cell processes, including immunomodulation and neuroprotection. BrainStorm's proprietary exosomes are developed from MSC-NTF cells.  They can serve as nano-carriers to effectively deliver bio-active molecules to target tissues and cells in a non-invasive manner. They have significant therapeutic potential in different therapeutic areas, including respiratory and neurodegenerative diseases, based on their unique biological characteristics, customizable cargo, intrinsic immunomodulatory properties and ability to target specific CNS pathways. 

About BrainStorm Cell Therapeutics Inc.   

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative therapies for debilitating neurodegenerative diseases, leveraging both autologous and allogeneic platforms. The Company holds exclusive worldwide licensing rights for the NurOwn® technology platform, which produces autologous MSC-NTF cells. These cells have received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for amyotrophic lateral sclerosis (ALS). BrainStorm is currently planning the launch of a confirmatory Phase 3b trial in ALS with NurOwn to further evaluate its safety and efficacy. BrainStorm's exosome technology, derived from MSC-NTF cells, represents an allogeneic therapeutic platform, providing customizable, nano-carrier-based solutions for targeted delivery of bioactive molecules. These exosomes exhibit unique immunomodulatory properties and are designed to address critical pathways in neurodegenerative and respiratory diseases. The Company has completed a Phase 3 trial assessing NurOwn in ALS and advanced clinical studies of NurOwn in progressive multiple sclerosis (MS), supported by grants from the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements  

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.             

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm Cell Therapeutic's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm Cell Therapeutic's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm Cell Therapeutic's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm Cell Therapeutic's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm Cell Therapeutic's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

IR:
Michael Wood
Phone: +1 646-597-6983
mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

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SOURCE BrainStorm Cell Therapeutics Inc.

FAQ

What patent did BrainStorm Cell Therapeutics (BCLI) receive in December 2023?

BrainStorm received a Notice of Allowance from the USPTO for patent application 16/981,757, covering its proprietary exosome technology derived from MSC-NTF cells.

How long will BrainStorm's (BCLI) new exosome patent protection last?

The patent is expected to provide protection until April 10, 2039, subject to standard term adjustments.

What neurotrophic factors are included in BrainStorm's (BCLI) patented exosome technology?

The patented exosomes contain at least one of the following neurotrophic factors: LIF, VEGFA, and GDF-15.

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