HACKENSACK, N.J. and PETACH TIKVAH, Israel, May 10, 2016 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced financial results and provided a business update for the first quarter ended March 31, 2016.
"The first quarter of 2016 reflects important accomplishments for BrainStorm, moving us closer to potentially providing a safe and efficacious, much-needed new treatment for patients with Amyotrophic Lateral Sclerosis (ALS)," stated Chaim Lebovits, CEO of BrainStorm. "Patients in our ongoing multicenter Phase 2 trial for our lead therapeutic candidate NurOwn® are now in the final follow up period, dosing having been completed last year. We look forward to announcing top line results around midyear."
"Preparations are now at an advanced stage for our Phase 2 multi dose trial with NurOwn which will be conducted at the Hadassah Medical Center in Jerusalem," continued Mr. Lebovits. "This trial will explore the safety and efficacy of a multi dose treatment with NurOwn, and has been designed to provide guidance for further clinical development as well as giving us additional insight into the treatment effect."
First Quarter 2016 and Recent Highlights
- Lead product NurOwn is currently being investigated in a multicenter, double blind, placebo controlled Phase 2 clinical trial in 48 patients with ALS:
- The trial is being conducted at three clinical sites in the U.S: Massachusetts General Hospital (MGH) in Boston, MA, University of Massachusetts Memorial (UMass) Hospital in Worcester, MA, and Mayo Clinic in Rochester, Minnesota.
- Enrollment and dosing of all patients was completed during 2015, follow up visits on all patients are expected to be complete.
- Top line results are expected around mid-2016.
- In January 2016 the Company entered into a collaborative agreement with Hadassah Medical Center in Jerusalem, Israel, to conduct the planned multi dose Phase 2 trial with NurOwn in ALS:
- Patients will receive three consecutive stem cell transplantations in order to explore the safety and efficacy of a multi dose treatment.
- The multi dose study is designed to provide guidance for further clinical development of NurOwn therapy in ALS.
- Approval for this trial has been received by the Hadassah's Helsinki Committee and the Company is now awaiting the approval of the Israeli MoH.
- In January 2016 a paper was published in JAMA Neurology discussing the outcome of the first in man Phase 1/2 study and Phase 2 dose escalation study with NurOwn in ALS.
- In April 2016 the Company presented at the ISRASTEM 2016 and 6th Israel Stem Cell Society (ISCS) joint annual meeting which took place in Tel Aviv, Israel. Combined results of the prior Phase 1/2 and Phase 2a clinical studies that investigated NurOwn in ALS were presented.
Financial Results for the First Quarter Ended March 31, 2016
- Research and development expenses for the three months ended March 31, 2016 were $986,000, compared to $1,245,000 in the first quarter of 2015.
- General and administrative expenses for the three months ended March 31, 2016 were approximately $826,000, compared to $960,000 in the first quarter of 2015.
- Loss from operation for the three months ended March 31, 2016 was $1,812,000 compared to $2,205,000 in the first quarter of 2015.
- Net loss for the three months ended March 31, 2016 was $1,790,000, or ($0.10) per share, compared to a net loss of $2,236,000, or ($0.12) per share in the first quarter of 2015.
- As of March 31, 2016, the Company had cash, cash equivalents, and short-term deposits of approximately $12.9 million.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to over 60 patients with ALS in clinical trials conducted in Israel and the United States, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial at three major clinical centers in the United States. For more information, visit the Company's website at www.brainstorm-cell.com.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov.
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