BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell technologies for neurodegenerative
diseases, today announces financial results for fiscal year ended
December 31, 2019.
“2019 was a tremendous year for BrainStorm, with
significant progress and achievements across all clinical and
operational fronts,” stated Chaim Lebovits, President and Chief
Executive Officer of BrainStorm. “Most importantly, we fully
enrolled our pivotal, double blind, placebo-controlled Phase 3
trial of NurOwn® for the treatment of ALS. We announced the trial
conducted at six major U.S. medical centers of excellence for ALS,
was fully enrolled on October 11, 2019, and on October 28, 2019 the
Data and Safety Monitoring Board (DSMB), completed the second
planned interim safety analysis for the first 106 patients who
received repeat dosing of NurOwn in the Phase 3 trial. The DSMB
concluded the trial should continue as planned without any clinical
protocol changes.” He added, “In addition, one of the most
prestigious peer-reviewed journals, Neurology,
published ‘NurOwn Phase 2 Randomized Clinical Trial in ALS: Safety,
Clinical and BioMarker Results,’ bringing news of our
investigational therapy to the global scientific community. And,
just last week, we were happy to announce that the Company recently
held a high level meeting with the U.S. Food and Drug
Administration (FDA) to discuss potential NurOwn regulatory
pathways for approval in ALS.”
Ralph Kern, MD, MHSc, Chief Operating Officer
and Chief Medical Officer of BrainStorm added, “2019 was also a
very significant year for those who suffer from progressive
Multiple Sclerosis (MS). In February 2019, we announced Cleveland
Clinic would serve as our first contracted site for a Phase 2
open-label, multicenter study of repeated intrathecal
administration of NurOwn (autologous MSC-NTF cells) in participants
with progressive MS (NCT03799718). We enrolled our first patient in
March. We contracted with The Stanford University School of
Medicine, The Keck School of Medicine of the University of Southern
California, and the Mount Sinai Medical Center to further enroll
patients.” Dr. Kern added, “The importance of our research in
progressive MS was acknowledged by a $495,000 grant award from the
National Multiple Sclerosis Society through it’s Fast Forward
Program, and mid-December, the Data Safety Monitoring Board
completed the first, pre-specified interim analysis, of safety
outcomes for 9 participants and after careful review of all
available clinical trial data, the DSMB unanimously concluded that
the study should continue as planned without any protocol
modification. As of December 31, 2019 we have enrolled 10 patients
in the study (50% enrollment completed).”
Fourth Quarter Corporate
Highlights:
- Received notice of US Patent Allowance for NurOwn Cellular
Therapeutic Technology Platform
- Grant of New Japanese Patent for NurOwn
- Presentations at the 30th International Symposium on
ALS/MND
- Phase 2 Biomarker Data Presentation at NEALS 18th Annual
Meeting
- Chaim Lebovits as Keynote Speaker at Cell Series UK 2019
- Presentation at 7th Annual International Stem Cell Meeting
- Presentation at 35th ECTRIMS Congress
- Presentation at Neuromuscular Drug Development Summit
- Presentation at Dawson James Securities 5th Annual Small Cap
Growth Conference
Financial Results for the Year Ended
December 31, 2019 and Recent Updates
- Cash, cash equivalents, and short-term bank deposits were
approximately $0.6 million as of December 31, 2019.
- As of February 14, 2020, we raised gross proceeds of
approximately $18.6 million utilizing the ATM facility.
- Cash, cash equivalents, and short-term bank deposits as of
today were approximately $11.1 million.
- In addition, available funding from non-dilutive CIRM and IIA
grants amounts to approximately $3.4 million.
- Research and development expenses, net, for the year ended
December 31, 2019 were $17.2 million, compared to $8.3 million, net
for year ended December 31, 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 $8.4 million from
$16.3 million for the year ended December 31, 2018 to $24.7 million
for the year ended December 31, 2019.
- General and administrative expenses for the year ended December
31, 2019 and 2018 were $5.79 million and $5.77 million
respectively.
- Net loss for the year ended December 31, 2019 was $23.2
million, or ($1.06) per share, as compared to a net loss of $13.9
million or ($0.70) per share for the year ended December 31,
2018.
- As of February 14, 2019, the Company had 26,230,839 shares and
4,474,868 warrants issued and outstanding.
For further details on BrainStorm’s financials,
including financial results for the year ended December 31, 2019,
refer to the Form 10-K filed with the SEC today.
Conference Call on Tuesday, February
18th @ 8:00 am Eastern Time
The investment community may participate in the
conference call by dialing the following numbers:
Conference ID: |
13698896 |
Toll Free: |
1-877-423-9813 |
Toll/International: |
1-201-689-8573 |
Audio Webcast: |
Link to Webcast |
Those interested in listening to the conference call live via
the internet may do so by visiting the “Investors & Media” page
of BrainStorm’s website at www.ir.brainstorm-cell.com and clicking
on the conference call link.
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: |
13698896 |
Replay Start: |
Tuesday February 18, 2020, 11:00 AM ET |
Replay Expiry: |
Tuesday March 3, 2020, 11:59 PM ET |
About NurOwn®NurOwn® (autologous MSC-NTF cells) represent a
promising investigational 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. NurOwn® is
currently being evaluated in a Phase 3 ALS randomized
placebo-controlled trial and in a Phase 2 open-label multicenter
trial in Progressive MS.
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® Cellular Therapeutic Technology Platform used to
produce autologous MSC-NTF cells through an exclusive, worldwide
licensing agreement as well as through its own patents, patent
applications and proprietary know-how. 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 the 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 BLA filing
for U.S. FDA approval of autologous MSC-NTF cells in ALS.
Brainstorm received U.S. FDA clearance to initiate a
Phase 2 open-label multi-center trial of repeat intrathecal dosing
of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718)
in December 2018 and has been enrolling clinical trial
participants since March 2019. For more information, visit the
company's website.
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:
646-666-3188uri@brainstorm-cell.com
Investor Relations: Preetam Shah, MBA, PhD
Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone:
862-397-8160pshah@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR PR Phone:
+1.646.677.1839sean.leous@icrinc.com
BRAINSTORM CELL THERAPEUTICS
INC.
CONSOLIDATED BALANCE SHEETSU.S. dollars
in thousands(Except share data)
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
U.S. $ in thousands |
ASSETS |
|
|
|
|
|
Current
Assets: |
|
|
Cash and cash equivalents |
$ |
536 |
|
|
$ |
942 |
|
Short-term deposit (Note
9) |
|
33 |
|
|
|
6,122 |
|
Other accounts receivable
(Note 4) |
|
2,359 |
|
|
|
2,009 |
|
Prepaid expenses and other
current assets (Note 5) |
|
432 |
|
|
|
1,197 |
|
Total current
assets |
|
3,360 |
|
|
|
10,270 |
|
|
|
|
Long-Term
Assets: |
|
|
Prepaid expenses and other
long-term assets |
|
32 |
|
|
|
307 |
|
Operating lease right of use
asset (Note 6) |
|
2,182 |
|
|
|
- |
|
Property and Equipment, Net
(Note 7) |
|
960 |
|
|
|
651 |
|
Total Long-Term
Assets |
|
3,174 |
|
|
|
958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets |
$ |
6,534 |
|
|
$ |
11,228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
|
Current
Liabilities: |
|
|
Accounts payable |
$ |
14,677 |
|
|
$ |
4,548 |
|
Accrued expenses |
|
1,000 |
|
|
|
1,042 |
|
Operating lease liability
(Note 6) |
|
1,263 |
|
|
|
- |
|
Other accounts payable |
|
714 |
|
|
|
622 |
|
Total current
liabilities |
|
17,654 |
|
|
|
6,212 |
|
|
|
|
Long-Term
Liabilities: |
|
|
Operating lease liability
(Note 6) |
|
1,103 |
|
|
|
- |
|
Total long-term
liabilities |
|
1,103 |
|
|
|
- |
|
|
|
|
Total
liabilities |
$ |
18,757 |
|
|
$ |
6,212 |
|
|
|
|
Stockholders' Equity
(deficit): |
|
|
Stock capital: (Note 11) |
|
11 |
|
|
|
11 |
|
Common Stock of $0.00005 par
value - Authorized: 100,000,000 shares at December 31, 2019 and
December 31, 2018 respectively; Issued and outstanding: 23,174,228
and 20,757,816 shares at December 31, 2019 and December 31, 2018
respectively. |
|
|
Additional
paid-in-capital |
|
105,042 |
|
|
|
94,620 |
|
Receipts on account of
shares |
|
- |
|
|
|
4,408 |
|
Accumulated deficit |
|
(117,276 |
) |
|
|
(94,023 |
) |
Total stockholders'
equity (deficit) |
|
(12,223 |
) |
|
|
5,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
$ |
6,534 |
|
|
$ |
11,228 |
|
BRAINSTORM CELL THERAPEUTICS
INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSSU.S. dollars in thousands(Except share
data)
|
Year ended |
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
U.S. $ in thousands |
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development, net (Note 12) |
$ |
17,204 |
|
|
$ |
8,293 |
|
General and
administrative |
|
5,797 |
|
|
|
5,770 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(23,001 |
) |
|
|
(14,063 |
) |
|
|
|
Financial expenses (income),
net |
|
252 |
|
|
|
(115 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(23,253 |
) |
|
$ |
(13,948 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(1.06 |
) |
|
$ |
(0.70 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding used in computing basic and diluted net loss per
share |
|
21,906,257 |
|
|
|
19,997,710 |
|
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