"2017 was a very productive year for BrainStorm, with significant progress and achievements across clinical, operational and financial fronts," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Most importantly, we began treating patients in our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn® for the treatment of ALS. The trial is being conducted at six leading ALS centers in the U.S., and is supported by a $16 million non-dilutive grant from the California Institute of Regenerative Medicine (CIRM)."
"We met and exceeded expectations in 2017 on the manufacturing and product development fronts," continued Mr. Lebovits. "We contracted with the City of Hope's Center for Biomedicine and Genetics in California, to produce clinical supplies of NurOwn for our US Phase 3 trial. Furthermore we have recently been granted Good Manufacturing Practice (GMP) certification by the Israel Ministry of Health (MoH) for our Israeli contract manufacturing facility. "
"We are building a world class team at BrainStorm and made a number of senior management appointments throughout 2017 including Ralph Z. Kern, MD, MHSc (Chief Operating Officer and Chief Medical Officer), Mary Kay Turner (VP of Patient Advocacy and Government Affairs), and Eyal Rubin (CFO). BrainStorm has also recently elected Senior Kite Pharma executive Anthony Polverino, Ph.D., to its Board of Directors," concluded Mr. Lebovits.
Fourth Quarter and Recent Corporate Highlights:
Financial Results for the Year Ended December 31, 2017
Conference Call on Thursday, March 8 th @ 8:30am Eastern Time Members of BrainStorm's senior management team, including Chaim Lebovits, CEO, and Ralph Kern, M.D., MHSc, COO and CMO, and Eyal Rubin, CFO will host a conference call and live webcast for the investment community on Thursday, March 8 th @ 8:30am Eastern Time. The details are as follows:
Toll Free:
1-800-289-0438
International:
1-323-794-2423
Israel Toll Free:
1-809-212-883
Conference ID:
3071165
Webcast:
https://goo.gl/MnoNzL
Replay: Dial-In – available through March 22, 2018 / Webcast – available through March 7, 2019 :
Toll Free:
1-844-512-2921
Toll/international:
1-412-317-6671
Replay Pin Number:
3071165
Webcast:
https://goo.gl/MnoNzL
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 Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com
| 2 0 1 7 U.S. $ in thousands | 2 0 1 6 U.S. $ in thousands | |
|---|---|---|
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $ 2,483 | $ 547 |
| Short-term deposit (Note 8) | 5,273 | 9,443 |
| Account receivable (Note 4) | 672 | 306 |
| Prepaid expenses and other current assets | 1,195 | 148 |
| Total current assets | 9,623 | 10,444 |
| Long-Term Assets: | ||
| Prepaid expenses and other long-term assets (Note 5) | 1,408 | 25 |
| Property and Equipment, Net (Note 6) | 392 | 297 |
| Total Long-Term Assets | 1,800 | 322 |
| Total assets | $ 11,423 | $ 10,766 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current Liabilities: | ||
| Accounts payables | $ 1,424 | $ 345 |
| Accrued expenses | 817 | 152 |
| Deferred grant income (Note 9) | 2,625 | - |
| Other accounts payable | 677 | 367 |
| Total current liabilities | 5,543 | 864 |
| Total liabilities | $ 5,543 | $ 864 |
| Stockholders' Equity: | ||
| Stock capital: (Note 10) | 11 | 11 |
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2017 and December 31, 2016 respectively; Issued and outstanding: 18,976,169 and 18,687,987 shares at December 31, 2017 and December 31, 2016 respectively. | ||
| Additional paid-in-capital | 85,944 | 85,014 |
| Accumulated deficit | (80,075) | (75,123) |
| Total stockholders' equity | 5,880 | 9,902 |
| Total liabilities and stockholders' equity | $ 11,423 | $ 10,766 |
| 2 0 1 7 U.S. $ in thousands | 2 0 1 7 U.S. $ in thousands | 2 0 1 6 U.S. $ in thousands | 2 0 1 6 U.S. $ in thousands | |
|---|---|---|---|---|
| Operating expenses: | ||||
| Research and development, net (Note 11) | $ 977 | $ 977 | $ 977 | $ 2,250 |
| General and administrative | 4,022 | 4,022 | 4,022 | 2,833 |
| Operating loss | (4,999) | (4,999) | (4,999) | (5,083) |
| Financial expenses (income), net | (47) | (47) | (47) | (101) |
| Taxes on income (Note 12) | - | - | - | - |
| Net loss | $ (4,952) | $ (4,952) | $ (4,952) | $ (4,982) |
| Basic and diluted net loss per share from continuing operations | $ (0.26) | $ (0.26) | $ (0.26) | $ (0.27) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 18,777,348 | 18,777,348 | 18,777,348 | 18,663,162 |
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
December 31,
2 0 1 7
2 0 1 6
U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents
$ 2,483
$ 547
Short-term deposit (Note 8)
5,273
9,443
Account receivable (Note 4)
672
306
Prepaid expenses and other current assets
1,195
148
Total current assets
9,623
10,444
Long-Term Assets:
Prepaid expenses and other long-term assets (Note 5)
1,408
Property and Equipment, Net (Note 6)
392
297
Total Long-Term Assets
1,800
322
Total assets
$ 11,423
$ 10,766
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payables
$ 1,424
$ 345
Accrued expenses
817
152
Deferred grant income (Note 9)
2,625
Other accounts payable
677
367
Total current liabilities
5,543
864
Total liabilities
$ 5,543
$ 864
Stockholders' Equity:
Stock capital: (Note 10)
Common Stock of $0.00005 par value - Authorized: 100,000,000
shares at December 31, 2017 and December 31, 2016
respectively; Issued and outstanding:
18,976,169 and 18,687,987 shares at December 31, 2017
and December 31, 2016 respectively.
Additional paid-in-capital
85,944
85,014
Accumulated deficit
(80,075)
(75,123)
Total stockholders' equity
5,880
9,902
Total liabilities and stockholders' equity
$ 11,423
$ 10,766
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands
(Except share data)
Year ended
December 31,
2 0 1 7
2 0 1 6
U.S. $ in thousands
Operating expenses:
Research and development, net (Note 11)
$ 977
$ 2,250
General and administrative
4,022
2,833
Operating loss
(4,999)
(5,083)
Financial expenses (income), net
(47)
(101)
Taxes on income (Note 12)
Net loss
$ (4,952)
$ (4,982)
Basic and diluted net loss per share from
continuing operations
$ (0.26)
$ (0.27)
Weighted average number of shares
outstanding used in computing basic and
diluted net loss per share
18,777,348
18,663,162
Contacts
Media:
Uri Yablonka
Chief Business Officer
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 7
2 0 1 6
U.S. $ in thousands
ASSETS
Current Assets:
Cash and cash equivalents
$ 2,483
$ 547
Short-term deposit (Note 8)