"2015 continues to be a year of important advances in our clinical and corporate programs," stated BrainStorm's CEO, Chaim Lebovits. "Specifically, we are making significant progress in the ongoing development program of our lead development candidate, NurOwn®, for the treatment of patients with amyotrophic lateral sclerosis (ALS). Of particular note, in August, we completed enrollment in the Phase II clinical, being conducted at three major academic medical centers in the U.S. We have now completed dosing of all patients, and the DSMB overseeing this trial identified no safety concerns in their recent review. We are pleased to have achieved these milestones and anticipate reporting top-line results from the trial prior to the end of the second quarter of 2016."
"At the end of September, I was proud to be appointed to the position of Chief Executive Officer of BrainStorm, expanding the role I have played at the Company since 2007," commented Mr. Lebovits. "This is a very important time in the history of BrainStorm, and I am honored to be leading the Company into the next phase of its development."
"Moving forward," continued Mr. Lebovits, "we are excited about the potential of our NurOwn technology to improve treatment options for patients with ALS. Our strong financial position, including our robust cash reserves, should provide the financial flexibility for BrainStorm to achieve its planned clinical milestones, including completion of the Phase 2 trial of NurOwn, as well as other product and development stage initiatives."
Third Quarter 2015 and Recent Highlights
- Completed enrollment in Phase II, randomized, double-blind, placebo-controlled multicenter clinical trial of NurOwn in ALS.
- Successful completion of Data and Safety Monitoring Board review of Phase II clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS).
- Appointment of Chaim Lebovits at Chief Executive Officer, building on strategic and operational experience, and history of leadership at BrainStorm.
Financial Results for the Third Quarter Ended September 30, 2015
- Research and development expenses for the three months ended September 30, 2015 were $1,503,000, compared to $1,572,000 in the third quarter of 2014.
- General and administrative expenses for the three months ended September 30, 2015 were approximately $1,068,000, compared to $858,000 in the third quarter of 2014.
- Loss from operation for the three months ended September 30, 2015 was $2,571,000 compared to $2,430,000 in the third quarter of 2014.
- Net loss for the three months ended September 30, 2015 was $2,603,000, or $0.14 per share, compared to a net loss of $2,421,000, or $0.16 per share in the third quarter of 2014.
- As of September 30, 2015, the Company had cash, cash equivalents, and short-term deposits of approximately $17.2 million, compared to $8.5 million at December 31, 2014.
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.
Forward-looking statements
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. These forward-looking statements 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: Investors:
Uri Yablonka Michael Rice
Chief Operating Officer LIFESCI ADVISORS, LLC
BRAINSTORM CELL THERAPEUTICS INC. Phone: (646) 597-6979
201-488-0460 mrice@lifesciadvisors.com
uri@brainstorm-cell.com
| September 30, 2 0 1 5 Unaudited | December 31, 2 0 1 4 Audited | |
|---|---|---|
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $ 710 | $ 4,251 |
| Short-term deposit | 16,441 | 4,290 |
| Account receivable | 823 | 1,005 |
| Prepaid expenses | 117 | 52 |
| Total current assets | 18,091 | 9,598 |
| Property and Equipment, Net | 268 | 313 |
| Total Assets | $ 18,359 | $ 9,911 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current Liabilities: | ||
| Accounts payables | $ 335 | $ 1,542 |
| Accrued expenses | 2,308 | 1,347 |
| Other accounts payable | 195 | 224 |
| Total Current Liabilities | 2,838 | 3,113 |
| Long-Term-Liabilities: | ||
| Warrants issued to investors | - | 123 |
| Total Long-Term Liabilities | - | 123 |
| Total Liabilities | 2,838 | 3,236 |
| Stockholders' Equity: | ||
| Stock capital: | 13 | 11 |
| Common stock of $0.00005 par value - Authorized: 100,000,000 and 800,000,000 shares at September 30, 2015 and December 31, 2014 respectively; Issued and outstanding: 18,480,957 and 15,281,497shares at September 30, 2015 and December 31, 2014 respectively. | ||
| Additional paid-in-capital | 84,265 | 68,317 |
| Accumulated deficit | (68,757) | (61,653) |
| Total Stockholders' Equity | 15,521 | 6,675 |
| Total Liabilities and Stockholders' Equity | $ 18,359 | $ 9,911 |
| Nine months ended September 30, 2015 Unaudited | Nine months ended September 30, 2014 Unaudited | Three months ended September 30, 2 0 1 5 Unaudited | Three months ended September 30, 2 0 1 4 Unaudited | |
|---|---|---|---|---|
| Operating costs and expenses: | ||||
| Research and development, net | $ 4,123 | $ 3,129 | $ 1,503 | $ 1,572 |
| General and administrative | 3,016 | 1,626 | 1,068 | 858 |
| Operating loss | (7,139) | (4,755) | (2,571) | (2,430) |
| Financial (income) expenses, net | (35) | 1,761 | 32 | (9) |
| Net loss | $ (7,104) | $ (6,516) | $ (2,603) | $ (2,421) |
| Basic and diluted net loss per share from continuing operations | $ (0.39) | $ (0.50) | $ (0.14) | $ (0.16) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 18,354,580 | 13,122,133 | 18,480,957 | 15,158,411 |
| Nine months ended September 30, 2015 Unaudited | Nine months ended September 30, 2014 Unaudited | Three months ended September 30, 2 0 1 5 Unaudited | Three months ended September 30, Unaudited | Three months ended September 30, 2 0 1 4 Unaudited | |
|---|---|---|---|---|---|
| Cash flows from operating activities: | |||||
| Net loss | $ (7,104) | $ (6,516) | $ (2,603) | $ (2,421) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||
| Depreciation and amortization of deferred charges | 73 | 80 | 26 | 30 | |
| Expenses related to shares and options granted to service providers | 108 | 186 | - | 76 | |
| Amortization of deferred stock-based compensation related to options granted to employees and directors | 955 | 578 | 287 | 280 | |
| Decrease (increase) in accounts receivable and prepaid expenses | 119 | 405 | (552) | 341 | |
| Increase (decrease) in trade payables | (1,207) | 1,076 | (420) | 547 | |
| Increase (decrease) in other accounts payable and accrued expenses | 932 | (13) | 732 | 66 | |
| Revaluation of warrants | 7 | 1,724 | - | (38) | |
| Total net cash used in operating activities | $ (6,117) | $ (2,480) | $ (2,530) | $ (1,119) |
| Nine months ended September 30, 2015 Unaudited | Nine months ended September 30, 2014 Unaudited | Three months ended September 30, 2 0 1 5 Unaudited | Three months ended September 30, 2 0 1 4 Unaudited | |
|---|---|---|---|---|
| Cash flows from investing activities: | ||||
| Purchase of property and equipment | $ (28) | $ (94) | $ (12) | $ - |
| Changes in short-term deposit | (12,151) | (1,600) | 1,953 | (1,600) |
| Investment in lease deposit | (2) | 1 | (2) | (6) |
| Total net cash used in investing activities | $ (12,181) | $ (1,693) | $ 1,939 | $ (1,606) |
| Cash flows from financing activities: | ||||
| Proceeds from issuances of common stock through equity warrants and options exercises | 2,348 | 685 | - | 470 |
| Proceeds from issuance of Common stock, net | - | 9,554 | - | (104) |
| Proceeds from equity offering through issuances of equity warrants and common stock through the exercise of previously issued equity warrants | 12,409 | - | - | - |
| Redemption of warrants in cash | - | (600) | - | - |
| Total net cash provided by financing activities | $ 14,757 | 9,639 | $ - | 366 |
| Increase (decrease) in cash and cash equivalents | (3,541) | 5,466 | (591) | (2,359) |
| Cash and cash equivalents at the beginning of the period | $ 4,251 | $ 3,503 | $ 1,301 | $ 11,328 |
| Cash and cash equivalents at end of the period | $ 710 | $ 8,969 | $ 710 | $ 8,969 |
| Non-cash financing activities: | ||||
| Stock issued for warrants exchange | - | 1,633 | - | - |
| Warrants liability classified as equity | 130 | 42 | - | - |
| Total non-cash financing activities | $ 130 | $ 1,675 | - | $ - |