"Despite the impact of COVID-19 on healthcare access, we completed enrollment and dosing of our Phase 3 ALS clinical trial and expanded our pipeline across new indications," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We want to recognize and thank the relentless dedication of the trial participants, their loved ones, our investigators and the team here at BrainStorm for this outstanding achievement. We expect a topline data readout by the end of November this year."
The application of NurOwn® as a platform technology in neurodegenerative disease has great potential and we are actively investing in clinical trials to evaluate the product in other conditions beyond ALS. The Phase 2 clinical trial ongoing in progressive multiple sclerosis (PMS) is expected to complete dosing by the end of 2020. In addition, we recently unveiled a clinical development program in Alzheimer's disease and are planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France. We believe that leveraging the NurOwn platform and potentially bringing much needed innovative treatment options to patients across multiple diseases will result in value creation for our various stakeholders.
Second Quarter 2020 and Recent Corporate Highlights:
Presented at the following Investor Conferences:
Cash and Liquidity as of July 31, 2020
Total available funding as of July 31, 2020, which includes cash on hand of approximately $34.7 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $37.5 million.
Financial Results for the Three Months Ended June 30, 2020
Conference Call & Webcast
Wednesday, August 5, 2020 at 8am Eastern Time
From the US: 877-407-9205International: 201-689-8054 Webcast: https://bit.ly/2DciAC9
Replays, available through August 19
From the US: 877-481-4010 International: 919-882-2331 Replay Passcode: 36017
About NurOwn
NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.
About BrainStorm Cell Therapeutics Inc.
| June 30, 2020 U.S. $ in thousand s | December 31, 2019 U.S. $ in thousand s | |
|---|---|---|
| ASSETS | Unaudited | Audited |
| Current Assets: | ||
| Cash and cash equivalents | $ 12,153 | $ 536 |
| Short-term deposit (Note 4) | 4,040 | 33 |
| Other accounts receivable | 259 | 2,359 |
| Prepaid expenses and other current assets (Note 5) | 176 | 432 |
| Total current assets | 16,628 | 3,360 |
| Long-Term Assets: | ||
| Prepaid expenses and other long-term assets | 26 | 32 |
| Operating lease right of use asset (Note 6) | 1,649 | 2,182 |
| Property and Equipment, Net | 918 | 960 |
| Total Long-Term Assets | 2,593 | 3,174 |
| Total assets | $ 19,221 | $ 6,534 |
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||
| Current Liabilities: | ||
| Accounts payable | $ 4,604 | $ 14,677 |
| Accrued expenses | 2,022 | 1,000 |
| Operating lease liability (Note 6) | 1,224 | 1,263 |
| Other accounts payable | 990 | 714 |
| Total current liabilities | 8,840 | 17,654 |
| Long-Term Liabilities: | ||
| Operating lease liability (Note 6) | 559 | 1,103 |
| Total long-term liabilities | 559 | 1,103 |
| Total liabilities | $ 9,399 | $ 18,757 |
| Stockholders' Equity (deficit): | ||
| Stock capital: (Note 7) | 12 | 11 |
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at June 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 29,669,855 and 23,174,228 shares at June 30, 2020 and December 31, 2019 respectively. | ||
| Additional paid-in-capital | 142,594 | 105,042 |
| Receipts on account of shares | - | - |
| Accumulated deficit | (132,784) | (117,276) |
| Total stockholders' equity (deficit) | 9,822 | (12,223) |
| Total liabilities and stockholders' equity | $ 19,221 | $ 6,534 |
| Six months ended June 30, 2020 Unaudited | Three months ended June 30, 2019 Unaudited | June 30, 2020 Unaudited | June 30, 2019 Unaudited | June 30, Unaudited | |
|---|---|---|---|---|---|
| Operating expenses: | |||||
| Research and development, net | $ 11,642 | $ 7,010 | $ 7,010 | $ 5,694 | $ 3,554 |
| General and administrative | 4,066 | 2,775 | 2,775 | 1,706 | 1,303 |
| Operating loss | (15,708) | (9,785) | (9,785) | (7,400) | (4,857) |
| Financial expenses (income), net | (200) | 142 | 142 | (6) | 43 |
| Net loss | $ (15,508) | $ (9,927) | $ (9,927) | $ (7,394) | $ (4,900) |
| Basic and diluted net loss per share from continuing operations | $ (0.56) | $ (0.47) | $ (0.25) | $ (0.23) | |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 27,452,750 | 21,312,335 | 21,312,335 | 29,274,130 | 21,703,001 |
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 has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites 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 Statement
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
Investor Relations:
Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (Except share data)
June 30,
December 31,
U.S. $ in thousands
ASSETS
Unaudited
Audited
Current Assets:
Cash and cash equivalents
$ 12,153
$ 536
Short-term deposit (Note 4)
4,040
Other accounts receivable
259
2,359
Prepaid expenses and other current assets (Note 5)
176
432
Total current assets
16,628
3,360
Long-Term Assets:
Prepaid expenses and other long-term assets
Operating lease right of use asset (Note 6)
1,649
2,182
Property and Equipment, Net
918
960
Total Long-Term Assets
2,593
3,174
Total assets
$ 19,221
$ 6,534
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities:
Accounts payable
$ 4,604
$ 14,677
Accrued expenses
2,022
1,000
Operating lease liability (Note 6)
1,224
1,263
Other accounts payable
990
714
Total current liabilities
8,840
17,654
Long-Term Liabilities:
Operating lease liability (Note 6)
559
1,103
Total long-term liabilities
559
1,103
Total liabilities
$ 9,399
$ 18,757
Stockholders' Equity (deficit):
Stock capital: (Note 7)
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at June 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 29,669,855 and 23,174,228 shares at June 30, 2020 and December 31, 2019 respectively.
Additional paid-in-capital
142,594
105,042
Receipts on account of shares
Accumulated deficit
(132,784)
(117,276)
Total stockholders' equity (deficit)
9,822
(12,223)
Total liabilities and stockholders' equity
$ 19,221
$ 6,534
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS(UNAUDITED)
U.S. dollars in thousands
(Except share data)
Six months ended
Three months ended
June 30,
June 30,
Unaudited
Unaudited
Operating expenses:
Research and development, net
$ 11,642
$ 7,010
$ 5,694
$ 3,554
General and administrative
4,066
2,775
1,706
1,303
Operating loss
(15,708)
(9,785)
(7,400)
(4,857)
Financial expenses (income), net
(200)
142
(6)
Net loss
$ (15,508)
$ (9,927)
$ (7,394)
$ (4,900)
Basic and diluted net loss per share from continuing operations
$ (0.56)
$ (0.47)
$ (0.25)
$ (0.23)
Weighted average number of shares outstanding used in computing basic and diluted net loss per share
27,452,750
21,312,335
29,274,130
21,703,001
Contacts
Corporate:
Uri Yablonka
Chief Business Officer
BrainStorm Cell Therapeutics Inc.
Phone: 646-666-3188
uri@brainstorm-cell.com
Investor Relations:
Preetam Shah, MBA, PhD
Chief Financial Officer
BrainStorm Cell Therapeutics Inc.
Phone: +1-862-397-1860
pshah@brainstorm-cell.com
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
June 30,
December 31,
2020
2019
U.S. $ in thousands
ASSETS
Unaudited
Audited
Current Assets: