BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced financial results for the three months and year ended December 31, 2014.
Tony Fiorino, MD, PhD, Chief Executive Officer of BrainStorm, stated, "We are extremely pleased with the progress we made in 2014, which was very productive from a clinical as well as operational perspective. We saw NurOwn® make significant advances in our amyotrophic lateral sclerosis (ALS) clinical development program, with the completion of our second Israeli clinical trial and the launch of our first US clinical trial, a randomized, double-blind, placebo-controlled phase 2 study. We also laid the groundwork for key manufacturing improvements, expanded our team to the U.S., and completed an uplisting to NASDAQ. With these and many other accomplishments behind us, BrainStorm is well positioned to continue moving NurOwn® forward in 2015."
Major Clinical Highlights for 2014 and early 2015:
- In June 2014, we commenced a U.S. multi-center, randomized, double-blind placebo-controlled phase 2 study of NurOwn® in ALS:
- Enrollment has passed the half-way mark and is expected to complete around mid-year.
- An interim safety look in January revealed no concerns.
- In the third quarter, NurOwn® was granted Fast Track Designation by the FDA to treat ALS.
- In January 2015, we reported positive final results of the Israeli phase 2a trial of NurOwn® in ALS.
- NurOwn produced large, clinically meaningful reductions in the rate of decline of both the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC).
Major Corporate Highlights for 2014 and early 2015:
- In June, we appointed Tony Fiorino, MD, PhD as Chief Executive Officer.
- In June, we raised $10.5 million in a private placement financing.
- In September, we completed a successful uplisting of BrainStorm common shares to NASDAQ.
- In January 2015, the majority of investors from the June 2014 private placement exercised their warrants in exchange for issuance of a new warrant, bringing in $13 million in gross proceeds.
Financial Results for the Quarter Ended December 31, 2014
Net R&D expenses for the fourth quarter of 2014 were $1.6 million, compared with $0.8 million for the fourth quarter of 2013. The increase was primarily the result of increased U.S. clinical trial expenses. In the fourth quarter, general and administrative expenses for 2014 totaled $1.0 million, compared with $0.5 million in 2013. This was driven by increased stock-based compensation, fees associated with uplisting to NASDAQ, and increased payroll. Financial expenses were $0.1 million in the fourth quarter, compared with income of $0.2 million in the fourth quarter of 2013. Net loss was $2.7 million, versus $1.2 million in 2013.
Financial Results for the Year Ended December 31, 2014
Gross R&D expenses for the year totaled $6.1 million compared with $4.0 million for 2013, primarily the result of increased U.S. clinical trial costs partially offset by reduced costs in Israel. Net of support from the Office of the Chief Scientist, R&D expenses for the year were $4.8 million in 2014 and $2.9 million in 2013. General and administrative expenses for 2014 totaled $2.7 million, compared with $2.1 million in 2013. This was driven by increased stock-based compensation, fees associated with uplisting to NASDAQ, and increased payroll. Financial expenses for 2014 totaled $1.8 million as a result of the re-valuation of certain warrants issued to investors in the August 2013 public offering. This compared with income of approximately $144,000 in 2013.
Net loss for the year ended December 31, 2014, was $9.3 million, or $0.68 per share, compared with a net loss of $4.9 million, or $0.46 cents per share, for the year ended December 31, 2013. The weighted average number of shares outstanding at year end 2014 was 13.7 million, compared with 10.7 million shares at year end 2013. As of December 31, 2014, BrainStorm had $8.5 million dollars in cash, cash equivalents and short-term deposits, compared with $3.5 million dollars at year-end 2013.
Conference Call & Webcast
The Company will host a conference call today at 8:30 a.m. EDT/5:30 a.m. PDT to discuss the Company's financial results.
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