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BrainStorm Cell Therapeutics Awarded Buzz of BIO 2020

23 Dec BrainStorm Cell Therapeutics Awarded Buzz of BIO 2020

BrainStorm Cell Therapeutics (NASDAQ: BCLI), a Company focussed on developing autologous cellular therapies for neurodegenerative diseases, has been awarded the Buzz of Bio 2020 in the public therapeutic biotech category. The award recognises the efforts of Brainstorm in the field of neurodegenerative diseases, including progressive multiple sclerosis (MS). The contest shortlists U.S companies that are engaged in groundbreaking, early-stage potential investigational therapies that can save lives as well as bridge the gap between companies and investors by helping them connect.

The awards recognise top biotechnology companies in three categories namely Public Therapeutic, Private Therapeutic and Diagnostics and beyond. BrainStorm was nominated in the Public Therapeutic Biotech category, which requires a Company to be actively involved in developing a human treatment to be reviewed by the U.S Food and Drug Administration.

The Company’s lead program NurOwn (MSC-NTF Cells), intended for treatment of patients with progressive MS, is currently enrolling patients in a phase 2 open-label trail, which is evaluating the safety and efficacy of repeated administration of NurOwn (MSC-NTF Cells). MSC-NTF Cells also known as Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors is the Company’s proprietary, targeted, innovative validated autologous cellular technology platform. The study is enrolling up to 20 adults with either secondary progressive or primary progressive MS at 3 sites in the U.S.

Chaim Lebovits, BrainStorm president and CEO, stated in a press release,

“Thanks to everyone who voted for BrainStorm during the Buzz of BIO competition,” He further added “The entire management team at BrainStorm was very pleased with the results of this competition, and we look forward to presenting to an audience of accredited investors who may benefit from the company’s story. We thank the BIO [Biotechnology Innovation Organization] team for singling out BrainStorm’s NurOwn as a key technology with the potential to improve lives.”

The Company is also being engaged in a phase III trial for treatment of patients with amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics (NASDAQ: BCLI)

Market Cap: $84M; Current Share Price: 3.70 USDChart
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Multiple Sclerosis is one of the diseases that will be covered under the National Neurological Conditions Surveillance System (NNCSS), a system that is being built by the Centers for Disease Control and Prevention (CDC) as part of the 21st Century Cures Act 2016, which has finally received funding in 2019 after being approved by the congress. As part of the initiative, it will collate data on areas of biggest impact for neurologic conditions such as incidence, age, race, ethnicity data, as well as geographic data.

A favorable government and regulatory environment, growing incidences of MS along with advancement in technology will propel the growth in the MS treatment Industry. However delay in diagnosis, prohibitive treatment costs along with adverse side-effects will hamper its growth. The global multiple sclerosis treatment market is expected to grow at a CAGR of 3.5% during forecasted period 2017-2023 according to a report by ResearchAndMarkets.Com which also predicts that the global multiple sclerosis drugs market which was valued at US$ 16.13 Billion in 2016 is expected to reach US$ 27.38 Billion by 2025, expanding at a CAGR of 6.3% from 2017 to 2025.

GlobalData’s report titled ‘Dynamic Market Forecast: Multiple Sclerosis’ projects that the MS market will grow in sales from $19,063M in 2016 to $25,566M in 2026 with a compound annual growth rate (CAGR) of 3%. Multiple Sclerosis affects approximately 1 million individuals in the US and 2.5 million worldwide according to a study. The direct healthcare cost of this illness is estimated to be in excess of $10 billion annually in the U.S alone.

Though the exact cause of this disorder is as yet unknown, some companies are using the rapid advancements in technology to improve diagnosis, understand the cause and alleviate the symptoms that are characteristic of MS Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig’s disease is a progressive neurodegenerative disease, characterized by the atrophy of nerve cells in brain and spinal cord, leading to hardening and scarring in the affected region. As the disease progresses, patients gradually lose the functioning of muscles, including those that control speech, movement and breathing. The disease manifests in two forms, sporadic and familial, with 90 to 95 percent of all cases in the U.S being Sporadic. Familial or the inherited form of the disease constitutes the other 5 to 10 percent.

According to information made available by the ALS association, there are over 16,500 Americans afflicted by this illness and nearly 5000 new cases are diagnosed each year. The life expectancy after diagnosis is merely 2 to 5 years, with an estimated $250,000 being spent on out-of-pocket treatment costs. The Global ALS treatment market is expected to be worth over USD 3.6 billion by 2026, growing at a CAGR of 21.6 percent, from USD 0.75 billion in 2018, according to a report by Data Bridge Market Research.

Image Source: ALS.org

BrainStorm is using its proprietary autologous cellular technology platform (NurOwn®) for creating innovative therapies for neurodegenerative diseases. The Company’s Autologous MSC-NTF cells platform, is capable of targeting disease pathways crucial in neurodegenerative disorders, and is obtained from a patient’s own bone marrow-derived MSC’s. Mesenchymal Stromal Stem Cells are harvested and differentiated in culture, to secrete high levels of Neurotrophic Factors, which are then injected into the patient. These enable the delivery of multiple NTF’s and immunomodulatory cytokines to the damaged areas and trigger a specific biological effect, thereby slowing the progression of the disease.

Image Source: Company

The Company has developed a proprietary method for the production of autologous MSC-NTF cells that involves engineering, producing and purifying autologous MSC-NTF cells and also offers scalability and quality. The treatment involves administering ready-for-injection syringes, containing 100-125 x 106 freshly-harvested autologous MSC-NTF cells, in a volume of 4 mL that are safe and tolerable. The Company has entered into an agreement with Dana-Farber Cancer Institute (Dana-Farber) in Boston, Massachusetts and the City of Hope National Medical Center in Duarte, California for provision of clean room facility for the production of autologous MSC-NTF cells.

BrainStorm has a robust intellectual rights portfolio for its NurOwn® technology platform, through an exclusive, worldwide licensing agreement, which gives it rights to clinical development and commercialization worldwide.

Image Source: Company

In addition, the Company’s pipeline consists of candidates for the treatment of ALS, Huntington’s disease, Parkinson’s disease, and Autism Spectrum Disorder. The Company is also conducting a phase 3 clinical trial in ALS and expects to announce topline data in Q4, 2020.

Risk Assessment

  • BrainStorm is developing therapeutics for markets with large unmet needs in ALS, and MS, two diseases that will rise as the geriatric population goes up further. These present an opportunity to the Company to be a first-in-class autologous stem cell therapy for ALS and other neurodegenerative diseases.
  • The Company has a diverse pipeline of candidates that target various neurodegenerative disorders. A diverse pipeline will help the Company capitalize on emerging opportunities in other areas as well as mitigate the risk in case of a failure or adverse results from its clinical trials.
  • BrianStorm has received a grant of $495K from The National MS Society (NMSS), for its Phase 2 biomarker study of NurOwn in progressive MS, which will help the Company explore key neuroinflammation and neural repair biomarkers in progressive MS.
  • The Company is expanding its patent portfolio, by recently adding additional United States and Japanese patents, for BrainStorm’s NurOwn cellular technology for the treatment of various neurogenerative diseases, which not only offers it protection but also safeguards its clinical developments.
  • Clinical trials are fraught with risk and unpredictable. The success of its clinical trials will help the Company advance its pipeline but it should also be prepared to face any setbacks, in case its ongoing trial fail to meet their endpoints.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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