BrainStorm Issues 2019 Letter to Shareholders
Dear Valued Shareholders,
2019 was an extraordinary year for
In the second week of October, we announced full enrollment of the 200-patient Phase 3 clinical trial (NCT03280056) evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). This clinical milestone is a key inflection point in the development of NurOwn as an investigational therapeutic and confirming BrainStorm as the leading biotechnology company developing autologous stem cell therapy treating neurogenerative disease.
At the end of 2018, we announced the expansion of our pipeline by introducing a new indication for NurOwn in progressive Multiple Sclerosis (MS). Progressive MS has deeply affected the lives of many and dramatically impacted family members, caregivers and others. Today, there is no U.S.
BrainStorm was recently awarded a grant of
We also expanded our intellectual patent portfolio by obtaining additional
Lastly, we strengthened our executive team by bringing on board Dr.
Our ongoing Phase 3 and Phase 2 clinical programs investigating NurOwn in ALS and progressive MS have received extensive and positive news coverage in the mainstream US media over the last year. I want to make sure that all our investors have an opportunity to read these articles and view these news items. The list of selected articles is listed below. The ABC Nightline segment was broadcast to more than 3 million households across the US and continues to be a major part of a full form documentary that will be broadcast by ABC Nightline and partners in 2020.
What is clear from these news items is that ALS and progressive MS represent significant unmet medical needs and that, despite the limited options currently available, patients are highly motivated to seek out new treatments and physicians recognize the potential of our autologous cellular therapy technology platform.
Approximately 6,000 people in the U.S. are diagnosed with ALS each year and more than 30,000 Americans are currently living with the disease. Worldwide it is estimated that 450,000 patients are living with ALS. Since 1995, only two new pharmaceuticals have been approved, but the medical need remains. NurOwn is the first autologous cellular investigational therapy to have advanced as far in a Phase 3 clinical trial. Progressive MS represents a US and worldwide addressable market opportunity of 500,000 and 1,250,000, individuals, respectively.
Looking ahead to 2020, we are highly focused on generating top-line results for our ALS phase 3 and progressive MS phase 2 trials in the fourth quarter, to initiating the regulatory submission and eventual commercialization of NurOwn in ALS, to further advancing our cellular technology and manufacturing capabilities. We will actively seek additional opportunities to expand our pipeline to address unmet need and to grow as a biotechnology company.
I want to personally thank you for your continued support.
President and CEO
Selected Video Clips:
ALS patients share about their life 5 years after 'Ice Bucket Challenge': Part 1
KTLA Southern California
Selected News Articles:
- ALS News Today – Phase 2 Trial Data on NurOwn Therapy, Supporting Safety And Early Efficacy, Published
- Multiple Sclerosis News Today – NMSS Awards
$495Kto Study Biomarkers in Phase 2 Trial of NurOwn in Progressive MS
- Seeking Alpha – Interview With Chaim Lebovits, CEO Of Brainstorm Cell Therapeutics
- ALS News Today – Phase 3 Trial of NurOwn, Cell Therapy for ALS, Gets Thumbs Up in Safety Review by Independent Board
- ALS News Today – Phase 3 Trial of NurOwn Cell Therapy Fully Enrolls 200 Patients, BrainStorm Announces
- ALS News Today – Advancing Potential ALS Treatments Is Like Accelerating a Glacier
- Money Week – How stem cells are changing the face of medicine
- MedPage Today –
Baby Step Forwardfor ALS Cell Therapy
- Multiple Sclerosis News Today – Progressive MS Phase 2 Trial of NurOwn Stem Cell Therapy Enrolls 1st Patient
Bloomberg– Namesake of ‘Right to Try’ Law Gets ALS Therapy, Says It’s Working
- Multiple Sclerosis New Today – BrainStorm Expands Production of Autologous Stem Cell Therapy NurOwn for Phase 2 Trial in Multiple Sclerosis
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause
Source: BrainStorm Cell Therapeutics Inc.