“We are actively enrolling participants in our Phase 3 trial of NurOwn® in ALS (Amyotrophic lateral sclerosis) and in our Phase 2 trial of NurOwn in Progressive MS (Multiple Sclerosis) in several of the preeminent U.S. medical institutions,” commented Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. He added, “We anticipate approximately 150 patients will be enrolled in our investigational trials for the treatment of ALS by the end of this month and we are working diligently to finalize enrollment of all 200 patients during the Third Quarter of 2019. We are also moving forward with several clinical centers of excellence that will oversee our investigational studies for the treatment of Progressive MS and we will update the community as sites formally contract with BrainStorm and begin patient enrollment. Finally, I am pleased, not only with the success of patient enrollments, I am excited to announce that the team at BrainStorm expanded the Company’s proprietary cellular technology platform to include NurOwn-derived exosomes for potential development across a broad range of Central Nervous System (CNS) disorders. We have a team of highly respected scientists advancing our understanding of stem cells and how they may one day offer breakthrough treatments for numerous unmet medical needs.”
First Quarter 2019 and Recent Corporate Highlights:
Financial Results for the Three Months Ended March 31, 2019
For further details on BrainStorm’s financials, including financial results for the three months ended March 31, 2019, refer to form 10Q filed with the SEC.
About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com
Safe-Harbor 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. 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
Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com Investors: Michael Levitan Solebury Trout Phone: 646-378-2920 mlevitan@soleburytrout.com
The accompanying notes are an integral part of the consolidated financial statements.
Source: BrainStorm Cell Therapeutics Inc.
Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460
Contacts
Corporate:
Uri Yablonka
Chief Business Officer
| March 31, 2 0 1 9 U.S. $ in thousands | March 31, 2 0 1 9 U.S. $ in thousands | March 31, 2 0 1 9 U.S. $ in thousands | December 31, 2 0 1 8 U.S. $ in thousands | December 31, 2 0 1 8 U.S. $ in thousands | December 31, 2 0 1 8 U.S. $ in thousands | |
|---|---|---|---|---|---|---|
| ASSETS | Unaudited | Unaudited | Unaudited | Audited | Audited | Audited |
| Current Assets: | ||||||
| Cash and cash equivalents | $ 3,238 | $ 942 | ||||
| Short-term deposit (Note 4) | 2,987 | 6,122 | ||||
| Account receivable | 795 | 2,009 | ||||
| Prepaid expenses and other current assets (Note 5) | 1,237 | 1,197 | ||||
| Total current assets | 8,257 | 10,270 | ||||
| Long-Term Assets: | ||||||
| Prepaid expenses and other long-term assets (Note 5) | 32 | 307 | ||||
| ROU assets | 2,951 | - | ||||
| Property and Equipment, Net | 611 | 651 | ||||
| Total long-term assets | 3,594 | 958 | ||||
| Total assets | $ 11,851 | $ 11,228 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Accounts payable | $ 5,029 | $ 4,548 | ||||
| Accrued expenses | 2,246 | 1,042 | ||||
| Deferred grant income (Note 7) | 511 | - | ||||
| Other accounts payable | 694 | 622 | ||||
| Total current liabilities | 8,480 | 6,212 | ||||
| Long-Term Liabilities: | ||||||
| Lease liability | 3,045 | - | ||||
| Total long-term liabilities | 3,045 | - | ||||
| Total liabilities | $ 11,525 | $ 6,212 | ||||
| Stockholders' Equity: | ||||||
| Stock capital: (Note 8) | 11 | 11 | ||||
| Common stock of $0.00005 par value - Authorized: 100,000,000 shares at each of March 31, 2019 and December 31, 2018; Issued and outstanding: 21,490,610 and 20,757,816 shares at March 31, 2019 and December 31, 2018, respectively. | ||||||
| Additional paid-in-capital | 98,325 | 94,620 | ||||
| Receipts on account of shares | 1,040 | 4,408 | ||||
| Accumulated deficit | (99,050) | (94,023) | ||||
| Total stockholders' equity | 326 | 5,016 | ||||
| Total liabilities and stockholders' equity | $ 11,851 | $ 11,228 |
| 2 0 1 9 U.S. $ in thousands | 2 0 1 9 U.S. $ in thousands | 2 0 1 9 U.S. $ in thousands | 2 0 1 8 U.S. $ in thousands | 2 0 1 8 U.S. $ in thousands | 2 0 1 8 U.S. $ in thousands | |
|---|---|---|---|---|---|---|
| Operating expenses: | Operating expenses: | |||||
| Research and development, net | Research and development, net | $ 3,456 | 3,456 | 3,456 | $ 977 | 977 |
| General and administrative | General and administrative | 1,472 | 1,472 | 1,472 | 1,330 | 1,330 |
| Operating loss | Operating loss | (4,928) | (4,928) | (4,928) | (2,307) | (2,307) |
| Financial expenses (income), net | Financial expenses (income), net | 99 | 99 | 99 | (9) | (9) |
| Net loss | Net loss | $ (5,027 | (5,027) | (5,027) | $ (2,298 | (2,298) |
| Basic and diluted net loss per share from continuing operations | Basic and diluted net loss per share from continuing operations | $ (0.24 | (0.24) | (0.24) | $ (0.12 | (0.12) |
| 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 | 20,917,329 | 20,917,329 | 20,917,329 | 19,047,350 | 19,047,350 |
BrainStorm Cell Therapeutics Inc.
Phone: 646-666-3188
uri@brainstorm-cell.com
Investors:
Michael Levitan
Solebury Trout
Phone: 646-378-2920
mlevitan@soleburytrout.com
The accompanying notes are an integral part of the consolidated financial statements.