Toll/International: 1-412-317-6671
Replay Pin Number: 13693394
Replay Start: Tuesday August 13, 2019, 11:00 AM ET Replay Expiry: Tuesday August 27, 2019, 11:59 PM ET
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, including statements regarding future clinical trial enrollment and data, 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, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; 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
| June 30, 2 0 1 9 U.S. $ in thousands | June 30, 2 0 1 9 U.S. $ in thousands | June 30, 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 | $ 1,126 | $ 942 | ||||
| Short-term deposit | 1,575 | 6,122 | ||||
| Account receivable | 1,917 | 2,009 | ||||
| Prepaid expenses and other current assets | 917 | 1,197 | ||||
| Total current assets | 5,535 | 10,270 | ||||
| Long-Term Assets: | ||||||
| Prepaid expenses and other long-term assets | 31 | 307 | ||||
| Operating lease right of use asset | 2,699 | - | ||||
| Property and Equipment, Net | 599 | 651 | ||||
| Total long-term assets | 3,329 | 958 | ||||
| Total assets | $ 8,864 | $ 11,228 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Accounts payable | $ 8,765 | $ 4,548 | ||||
| Accrued expenses | 1,020 | 1,042 | ||||
| Other accounts payable | 758 | 622 | ||||
| Total current liabilities | 10,543 | 6,212 | ||||
| Long-Term Liabilities: | ||||||
| Operating lease liability | 2,837 | - | ||||
| Total long-term liabilities | 2,837 | - | ||||
| Total liabilities | $ 13,380 | $ 6,212 | ||||
| Stockholders' Equity: | ||||||
| Stock capital: | 11 | 11 | ||||
| Common stock of $0.00005 par value - Authorized: 100,000,000 shares at each of June 30, 2019 and December 31, 2018; Issued and outstanding: 21,708,442 and 20,757,816 shares at June 30, 2019 and December 31, 2018, respectively. | ||||||
| Additional paid-in-capital | 99,423 | 94,620 | ||||
| Receipts on account of shares | - | 4,408 | ||||
| Accumulated deficit | (103,950) | (94,023) | ||||
| Total stockholders' equity (deficit) | (4,516) | 5,016 | ||||
| Total liabilities and stockholders' equity | $ 8,864 | $ 11,228 |
| Six months ended June 30, 2 0 1 9 Unaudited | Six months ended June 30, 2 0 1 8 Unaudited | Three months ended June 30, 2 0 1 9 Unaudited | Three months ended June 30, 2 0 1 8 Unaudited | |
|---|---|---|---|---|
| Operating expenses: | ||||
| Research and development, net | $ 7,010 | $ 2,458 | $ 3,554 | $ 1,481 |
| General and administrative | 2,775 | 2,936 | 1,303 | 1,606 |
| Operating loss | (9,785) | (5,394) | (4,857) | (3,087) |
| Financial expenses (income), net | 142 | (5) | 43 | 4 |
| Net loss | $ (9,927) | $ (5,389) | $ (4,900) | $ (3,091) |
| Basic and diluted net loss per share from continuing operations | $ (0.47) | $ (0.28) | $ (0.23) | $ (0.16) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 21,312,335 | 19,277,518 | 21,703,001 | 19,505,157 |
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data)
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
BrainStorm Cell Therapeutics Inc.
Phone: 646-666-3188
uri@brainstorm-cell.com
Investors:
Michael Levitan
Solebury Trout
Phone: 646-378-2920
mlevitan@soleburytrout.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands
(Except share data)