"2016 was a highly successful and pivotal year for Brainstorm, with a number of important achievements and significant progress made on clinical, regulatory and operational fronts," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. "We announced positive top-line Phase 2 data of NurOwn® in the treatment of amyotrophic lateral sclerosis (ALS), demonstrating the potential of this therapy to halt or reverse ALS disease progression. Following our End of Phase 2 meeting with the FDA, we are making final preparations to begin a Phase 3 clinical trial, which when successful will position us to bring to ALS patients and their families a much needed and innovative ALS disease modifying therapy."
2016 and Recent Clinical Highlights:
2016 and Recent Corporate Highlights:
Financial Results for the Fourth Quarter Ended December 31, 2016 Net R&D expenses for the fourth quarter of 2016 were $323,000, compared with $826,000 for the fourth quarter of 2015. The decrease was primarily the result of decreased U.S. clinical trial expenses. In the fourth quarter of 2016, general and administrative expenses were $327,000, compared with $571,000 in the same period of 2015. This was driven by decreased consultants expenses and decrease in Delaware Franchise Tax. Net loss for the fourth quarter was $624,000 or ($0.03) per share, versus $1.4 million or ($0.07) per share in the same period of 2015.
Financial Results for the Year Ended December 31, 2016 Research and Development expenses for the year ended December 31, 2016 were $2.3 million, compared to $4.9 million in the same period of 2015, primarily as a result of decreased U.S. clinical trial costs and partially offset by in the costs of activities related to the Israeli clinical trials and costs of materials. General and administrative expenses for the year were $2.8 million, compared to $3.6 million in the same period of 2015, primarily due to a decrease in the cost of our investor relations and public relations activities, our Delaware Franchise tax and rent. This decrease was partially offset by an increase in payroll expenses and consultants. Net loss for the year ended December 31, 2016, was $5.0 million, or ($0.27) per share, compared with a net loss of $8.5 million, or ($0.46) per share, for the year ended December 31, 2015.
As of December 31, 2016, BrainStorm had approximately $10.0 million in cash, cash equivalents and short-term deposits, compared with approximately $16.0 million at December 31, 2015.
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 approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. 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. 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.
CONTACTS
| 2 0 1 6 U.S. $ in thousands | 2 0 1 5 U.S. $ in thousands | |
|---|---|---|
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $ 547 | $ 428 |
| Short-term deposit | 9,443 | 15,527 |
| Account receivable (Note 4) | 306 | 759 |
| Prepaid expenses and other current assets | 148 | 74 |
| Total current assets | 10,444 | 16,788 |
| Long-Term Assets: | ||
| Prepaid expenses and other long-term assets | 25 | 21 |
| Property and Equipment, Net (Note 5) | 297 | 271 |
| Total Long-Term Assets | 322 | 292 |
| Total assets | $ 10,766 | $ 17,080 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current Liabilities: | ||
| Accounts payables | $ 345 | $ 1,169 |
| Accrued expenses | 152 | 1,500 |
| Other accounts payable | 367 | 283 |
| Total current liabilities | 864 | 2,952 |
| Total liabilities | $ 864 | $ 2,952 |
| Stockholders' Equity: | ||
| Stock capital: | 11 | 11 |
| Common stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2016 and December 31, 2015 respectively; Issued and outstanding: 18,687,987 and 18,643,288 shares at December 31, 2016 and December 31, 2015 respectively. | ||
| Additional paid-in-capital | 85,014 | 84,258 |
| Accumulated deficit | (75,123) | (70,141) |
| Total stockholders' equity | 9,902 | 14,128 |
| Total liabilities and stockholders' equity | $ 10,766 | $ 17,080 |
| 2 0 1 6 U.S. $ in thousands | 2 0 1 6 U.S. $ in thousands | 2 0 1 5 U.S. $ in thousands | 2 0 1 5 U.S. $ in thousands | |
|---|---|---|---|---|
| Operating expenses: | Operating expenses: | |||
| Research and development, net | Research and development, net | $ 2,250 | $ 2,250 | $ 4,949 |
| General and administrative | General and administrative | 2,833 | 2,833 | 3,587 |
| Operating loss | Operating loss | (5,083) | (5,083) | (8,536) |
| Financial expenses (income), net | Financial expenses (income), net | (101) | (101) | (48) |
| Taxes on income (Note 10) | Taxes on income (Note 10) | - | - | - |
| Net loss | $ (4,982) | $ (4,982) | $ (8,488) | |
| Basic and diluted net loss per share from continuing operations | Basic and diluted net loss per share from continuing operations | $ (0.27) | $ (0.27) | $ (0.46) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 18,663,162 | 18,663,162 | 18,405,610 |
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
December 31,
2 0 1 6
2 0 1 5
U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents
$ 547
$ 428
Short-term deposit
9,443
15,527
Account receivable (Note 4)
306
759
Prepaid expenses and other current assets
148
Total current assets
10,444
16,788
Long-Term Assets:
Prepaid expenses and other long-term assets
Property and Equipment, Net (Note 5)
297
271
Total Long-Term Assets
322
292
Total assets
$ 10,766
$ 17,080
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payables
$ 345
$ 1,169
Accrued expenses
152
1,500
Other accounts payable
367
283
Total current liabilities
864
2,952
Total liabilities
$ 864
$ 2,952
Stockholders' Equity:
Stock capital:
Common stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2016 and December 31, 2015 respectively; Issued and outstanding: 18,687,987 and 18,643,288 shares at December 31, 2016 and December 31, 2015 respectively.
Additional paid-in-capital
85,014
84,258
Accumulated deficit
(75,123)
(70,141)
Total stockholders' equity
9,902
14,128
Total liabilities and stockholders' equity
$ 10,766
$ 17,080
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands
(Except share data)
Year ended
December 31,
2 0 1 6
2 0 1 5
U.S. $ in thousands
Operating expenses:
Research and development, net
$ 2,250
$ 4,949
General and administrative
2,833
3,587
Operating loss
(5,083)
(8,536)
Financial expenses (income), net
(101)
(48)
Taxes on income (Note 10)
Net loss
$ (4,982)
$ (8,488)
Basic and diluted net loss per share from continuing operations
$ (0.27)
$ (0.46)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share
18,663,162
18,405,610
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-announces-financial-results-for-2016-and-provides-business-update-300431578.html
Contacts
Media:
Uri Yablonka
Brainstorm Cell Therapeutics Inc.
Phone: (646) 666-3188
uri@brainstorm-cell.com
Investors:
Michael Rice
LifeSci Advisors, LLC
Phone: 646-597-6979
mrice@lifesciadvisors.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
December 31,
2 0 1 6
2 0 1 5
U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents
$ 547
$ 428
Short-term deposit
9,443