BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update
November 14 2019 - 6:00AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell therapies for neurodegenerative
diseases, announced today financial results for the third quarter
ended September 30, 2019 and recent corporate updates.
“On October 11, 2019 we reached a major
corporate milestone by fully enrolling 200 patients in the Phase 3
clinical trial of NurOwn® in ALS (Amyotrophic Lateral Sclerosis).
Additionally, on October 28, we announced that we received
notification from the NurOwn Data Safety Monitoring Board (DSMB)
that after reviewing all of the safety data as of September 30, the
study should continue without any changes in the protocol. The DSMB
indicated they did not identify any significant safety concerns,”
stated Chaim Lebovits, President and Chief Executive Officer of
BrainStorm Cell Therapeutics. He added, “Our Phase 2 trial of
NurOwn in Progressive MS (Multiple Sclerosis) continues to enroll
patients in several of the leading U.S. medical centers and we
anticipate announcing additional investigational centers of
excellence in the near future. The first eight (8) participants
have been enrolled in the study.”
Third Quarter 2019 and Recent Corporate
Highlights:
- October 28, DSMB Recommends ALS
Phase 3 Clinical Trial Continue
- October 11, NurOwn Phase 3 Clinical
Trial Fully Enrolled
- October 7, Notice of US Patent
Allowance for NurOwn Cellular Therapeutics Technology Platform
- September 27, BrainStorm announced
support for FDA Guidelines on ALS Drug Development
- September 25, Convened a Roundtable
Discussion with ALS Advocacy Group Leaders and Members of The US
Congress and their Staff
- September 9, Preetam Shah, Ph.D.,
M.B.A. Appointed Chief Financial Officer
- Key
Presentations:-- November 12, Presentation at 7th Annual
International Stem Cell Meeting-- October 25, Presentation at
Dawson James Securities 5th Annual Conference-- October 24,
Chaim Lebovits, Keynote Speaker at Cell Series UK
2019-- October 23-25, Neuromuscular Drug Development Drug
Summit – Hosted workshop and presented on clinical trial
design-- October 2, North East Amyotrophic Lateral Sclerosis
Annual Meeting - Phase 2 Biomarker Data Poster
Presentation-- September 13, ECTRIMS Late Breaking News
ePoster
Financial Results for the Three Months
Ended September 30, 2019
- Cash, cash equivalents, and
short-term bank deposits were $2.1 million at September 30, 2019,
compared to $2.7 million at June 30, 2019.-- Our total
available funding which includes cash on hand as well as the
remaining non-dilutive CIRM and IIA grants amounts to approximately
$5.9 million
- Research and development expenses,
net, for the three months ended September 30, 2019 were $4.01
million, compared to $1.98 million, net for the three months ended
September 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 $1.59 million from $4.07 million in the third quarter
of 2018 to $5.66 million in the third quarter of 2019
- General and administrative expenses
for the three months ended September 30, 2019 were $1.54 million,
compared to $1.26 million in the three months ended September
2018.
- Net loss for the three months ended
September 2019 was $5.6 million, or ($0.25) per share, as compared
to a net loss of $3.18 million, or ($0.15) per share for the three
months ended September 30, 2018.
For further details on BrainStorm’s financials,
including financial results for the three months ended September
30, 2019, refer to Form 10-Q filed with the SEC on November 14th,
2019.
Conference Call and Webcast: Thursday,
November 14, 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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Webcast Link: |
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https://bit.ly/2XaKWmm |
A webcast replay of the conference call will be
available for 30 days on the “Investors & Media” page of
BrainStorm’s website:
Toll
Free: |
1-844-512-2921 |
Toll/International: |
1-412-317-6671 |
Replay Pin Number: |
13696529 |
Replay Start: |
Thursday, November 14, 2019, 11:00 AM ET |
Replay Expiry: |
Thursday, November 28, 2019, 11:59 PM ET |
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.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 StatementStatements
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
Media: Sean Leous Westwicke/ICR PR
Phone: +1.646.677.1839 sean.leous@icrinc.com
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED BALANCE SHEETSU.S.
dollars in thousands(Except share
data)
|
September 30, |
|
December 31, |
|
2 0 1 9 |
|
2 0 1 8 |
|
U.S. $ in thousands |
|
Unaudited |
|
Audited |
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
2,095 |
|
|
$ |
942 |
|
Short-term deposit (Note 4) |
|
34 |
|
|
|
6,122 |
|
Account receivable |
|
1,924 |
|
|
|
2,009 |
|
Prepaid expenses and other current assets (Note 5) |
|
619 |
|
|
|
1,197 |
|
Total current assets |
|
4,672 |
|
|
|
10,270 |
|
|
|
|
Long-Term Assets: |
|
|
Prepaid expenses and other long-term assets |
|
32 |
|
|
|
307 |
|
Operating lease right of use asset |
|
2,443 |
|
|
|
- |
|
Property and Equipment, Net |
|
664 |
|
|
|
651 |
|
Total long-term assets |
|
3,139 |
|
|
|
958 |
|
|
|
|
Total assets |
$ |
7,811 |
|
|
$ |
11,228 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities: |
|
|
Accounts payable |
$ |
9,144 |
|
|
$ |
4,548 |
|
Accrued expenses |
|
1,975 |
|
|
|
1,042 |
|
Other accounts payable |
|
839 |
|
|
|
622 |
|
Total current liabilities |
|
11,958 |
|
|
|
6,212 |
|
Long-Term Liabilities: |
|
|
Operating lease liability |
|
2,630 |
|
|
|
- |
|
Total long-term liabilities |
|
2,630 |
|
|
|
- |
|
Total liabilities |
$ |
14,588 |
|
|
$ |
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 September 30, 2019 and December 31, 2018; Issued and
outstanding: 22,606,492 and 20,757,816 shares at September 30, 2019
and December 31, 2018, respectively. |
|
|
Additional paid-in-capital |
|
102,796 |
|
|
|
94,620 |
|
Receipts on account of shares |
|
- |
|
|
|
4,408 |
|
Accumulated deficit |
|
(109,584 |
) |
|
|
(94,023 |
) |
Total stockholders' equity)
deficit) |
|
(6,777 |
) |
|
|
5,016 |
|
|
|
|
Total liabilities and stockholders' equity |
$ |
7,811 |
|
|
$ |
11,228 |
|
|
|
|
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS (UNAUDITED)U.S. dollars in
thousands(Except share data)
|
Nine months ended |
|
Three months ended |
|
September 30, |
|
September 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 |
$ |
11,018 |
|
|
$ |
4,433 |
|
|
$ |
4,008 |
|
|
$ |
1,975 |
|
General and administrative |
|
4,318 |
|
|
|
4,193 |
|
|
|
1,543 |
|
|
|
1,257 |
|
|
|
|
|
|
Operating loss |
|
(15,336 |
) |
|
|
(8,626 |
) |
|
|
(5,551 |
) |
|
|
(3,232 |
) |
|
|
|
|
|
Financial expenses (income), net |
|
225 |
|
|
|
(61 |
) |
|
|
83 |
|
|
|
(56 |
) |
|
|
|
|
|
Net loss |
$ |
(15,561 |
) |
|
$ |
(8,565 |
) |
|
$ |
(5,634 |
) |
|
$ |
(3,176 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share from continuing
operations |
$ |
(0.72 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.15 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding used in computing
basic and diluted net loss per share |
|
21,630,007 |
|
|
|
19,754,159 |
|
|
|
22,254,993 |
|
|
|
20,691,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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