BrainStorm Announces Financial Results for the First Quarter of 2019 and Provides a Corporate Update
May 10 2019 - 5:00PM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today financial results for the first quarter
ended March 31, 2019 and recent corporate updates.
“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:
- By the end of May 2019 we expect to have enrolled ~150 patients
in the company's phase 3 ALS randomized, double blind,
placebo-controlled, repeat-dose clinical trial. In the coming
months we expect to enroll 18-24 patients per month. By end of
August we expect to finalize enrollment of all 200
patients.
- The Company announced first patient in its Phase 2 open-label,
multicenter study of repeated intrathecal administration of
autologous MSC-NTF cells in participants with progressive MS.
- On January 11, 2019, Dr. Ralph Kern, Chief Operating Officer
and Chief Medical Officer, presented an update on the Phase 3
pivotal trial of the autologous MSC-NTF Cellular Therapy (NurOwn®)
in ALS at the 9th Annual California ALS Research Summit in Irvine,
CA.
- On March 28, 2019, the Company announced that two scientific
abstracts were accepted for presentation at the 71st American
Academy of Neurology (AAN) Annual
Meeting in Philadelphia, PA, May 4-10, 2019. The
scientific abstracts selected by the AAN for presentation provide a
detailed molecular genetics characterization of neurotrophic factor
production by NurOwn® and further correlate cerebrospinal
fluid biomarkers with clinical improvement in the completed Phase 2
ALS study. These findings contribute to our overall understanding
of the mechanism of action of NurOwn® and provide further
evidence linking ALS clinical outcomes to highly relevant disease
biomarkers.
- Strengthened intellectual property estate around NurOwn®:
° In December 2018, the Israel Patent Office granted a patent
titled “Methods of Generating Mesenchymal Stem Cells which Secrete
Neurotrophic Factors.”° In March 2019, the European Patent
Office ("EPO") granted a European-wide patent titled
'Mesenchymal Stem Cells for the treatment of CNS Diseases.' The
European Patent Application published in the European Patent
Bulletin 19/13 on 27 March 2019, under Patent No.
2620493.
- On April 30, 2019, the Company announced that it has expanded
its proprietary cellular technology platform to include
NurOwn®-derived exosomes for potential development across a broad
range of CNS disorders.
Financial Results for the Three Months
Ended March 31, 2019
- Cash, cash equivalents, and short-term bank deposits were $6.23
million at March 31, 2019, compared with $7.8 million at December
31, 2018. ° Cash, cash equivalents (including short-term bank
deposits) and cash commitments (including the remaining commitments
of $3 million from the CIRM grant and
approximately $1 million under the IIA 2018 grant)
amounted to approximately $10.23 million.
- Research and development expenses, net, for the three months
ended March 31, 2019 were $3.46 million, compared to $977,000, net
for the three months ended March 31, 2018.° Excluding
participation from IIA and CIRM under the grants, research and
development expenses increased by $2.03 million from $3.17 in the
first quarter of 2018 to $5.2 million in the first quarter of
2019.
- General and administrative expenses for the three months ended
March 31, 2019 were $1.5 million, in line with the $1.3 million
reported in the three months ended March 31, 2018.
- Net loss for the three months ended March 31, 2019 was $5
million, or ($0.24) per share, as compared to a net loss of $2.3
million, or ($0.12) per share for the three months ended March 31,
2018.
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.comInvestors:
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) |
|
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
|
2 0 1 9 |
|
2 0 1 8 |
|
|
|
|
|
|
|
U.S. $ in thousands |
|
|
|
ASSETS |
|
Unaudited |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIES |
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS (UNAUDITED) |
U.S. dollars in thousands |
(Except share data) |
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2 0 1 9 |
|
2 0 1 8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. $ in thousands |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development, net |
$ |
3,456 |
|
|
$ |
977 |
|
General and administrative |
|
1,472 |
|
|
|
1,330 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(4,928 |
) |
|
|
(2,307 |
) |
|
|
|
|
|
|
|
|
Financial expenses (income), net |
|
99 |
|
|
|
(9 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,027 |
) |
|
$ |
(2,298 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share from continuing
operations |
$ |
(0.24 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding used in computing
basic and diluted net loss per share |
|
20,917,329 |
|
|
|
19,047,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the
consolidated financial statements.
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