BrainStorm Announces Financial Results for the Second Quarter of 2019 and Provides a Corporate Update
August 13 2019 - 7:30AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today financial results for the second quarter
ended June 30, 2019 and recent corporate updates.
“We continue to actively enroll patients 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. “We anticipate completing enrollment
in our Phase 3 ALS study during the second week of October 2019 and
expect top-line results by eleven months after completion of
enrollment. Over the past few months, we were excited to add the
support of Stanford University School of Medicine and the Keck
School of Medicine of the University of Southern California as
additional sites currently enrolling patients in our Phase 2
Progressive MS study. We continue to appreciate the support of our
shareholders and patient advocacy groups as we advance the
development of NurOwn® to fill the unmet medical need for patients
with ALS and Progressive MS.”
Second Quarter 2019 and Recent Corporate
Highlights:
- By the end of July 2019, 170
patients enrolled in the Company's phase 3 ALS randomized, double
blind, placebo-controlled, repeat-dose clinical trial. By the
second week of October we expect to finalize enrollment of all 200
patients.
- In July 2019, the BrainStorm
management team was invited to a special high-level meeting with
FDA senior management and I AM ALS, a grass roots ALS advocacy
group advocating for an ALS cure.
- The Company added two additional
clinical sites to enroll patients in its Phase 2 open-label,
multicenter study of repeated intrathecal administration of
autologous MSC-NTF (NurOwn) cells in participants with progressive
MS.
- On May 31, 2019, Dr. Ralph Kern,
Chief Operating Officer and Chief Medical Officer, presented a
poster of the Company’s “Phase 2 Open-Label, Multicenter Study of
Repeated Intrathecal Administration of Autologous MSC-NTF cells in
Progressive Multiple Sclerosis (MS)” at the Annual Meeting of the
Consortium of Multiple Sclerosis Centers, in Seattle, WA.
- On May 16, 2019, Chaim Lebovits,
President and Chief Executive Officer, lead a roundtable discussion
titled “Stem Cells for Neurological Applications” at
the World Advanced Therapy and Regenerative Medicine Congress
in London, England.
Financial Results for the Three Months
Ended June 30, 2019
- Cash, cash equivalents, and
short-term bank deposits were $2.7 million at June 30, 2019,
compared to $6.23 million at March 31, 2019.
- Cash, cash equivalents (including short-term bank deposits) and
cash commitments (including the remaining commitments from the
CIRM and IIA grants) amounted to approximately $6.5 million.
- As of August 6, 2019, Cash, cash equivalents, and short-term
bank deposits were $4.5 million.
- Research and development expenses,
net, for the three months ended June 30, 2019 were $3.55 million,
compared to $1.5 million, net for the three months ended June 30,
2018.
- Excluding participation from IIA
and CIRM under the grants and proceeds received under the hospital
exemption regulatory pathway, research and development expenses
increased by $3.23 million from $3.3 million in the second quarter
of 2018 to $6.53 million in the second quarter of 2019
- Additional proceeds from Hospital
Exemption is expected it the upcoming quarter.
- General and administrative expenses
for the three months ended June 30, 2019 were $1.3 million,
compared to $1.6 million in the three months ended June 30,
2018.
- Net loss for the three months ended
June 30, 2019 was $4.9 million, or ($0.23) per share, as compared
to a net loss of $3.1 million, or ($0.16) per share for the three
months ended June 30, 2018.
For further details on BrainStorm’s financials,
including financial results for the three months ended June 30,
2019, refer to Form 10-Q filed with the SEC on August 13, 2019.
Conference Call and Webcast: Tuesday,
August 13, 2019 @ 8:00 a.m. Eastern Time
U.S. Toll Free |
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1-877-423-9813 |
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Toll/International: |
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1-201-689-8573 |
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Conference Call ID: |
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13693394 |
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Webcast Link: |
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http://public.viavid.com/player/index.php?id=135728 |
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Replays, Available through August 27,
2019:U.S. Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13693394
Replay Start: Tuesday August 13, 2019, 11:00 AM
ETReplay 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
Investors: Michael
Levitan Solebury Trout Phone:
646-378-2920 mlevitan@soleburytrout.com
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE
SHEETSU.S. dollars in thousands(Except share
data)
|
June 30, |
|
December 31, |
|
2 0 1 9 |
|
2 0 1 8 |
|
U.S. $ in thousands |
ASSETS |
Unaudited |
|
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 |
|
|
|
|
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, |
|
2 0 1 9 |
|
2 0 1 8 |
|
2 0 1 9 |
|
2 0 1 8 |
|
Unaudited |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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