NEW YORK, Aug. 5, 2020 /PRNewswire/ -- BrainStorm Cell
Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular
therapies for neurodegenerative diseases, announced today financial
results for the second quarter and first half ended June 30, 2020, and provided a corporate
update.
"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:
- Completed dosing of all patients in the ongoing NurOwn Phase 3
clinical trial in amyotrophic lateral sclerosis (ALS).
- NurOwn is being investigated in a Phase 2 clinical trial in
patients with progressive multiple sclerosis (PMS) which is ongoing
at 5 leading U.S. MS centers. As of August
4, 2020, all 20 study participants have been enrolled in the
study and dosing is expected to be completed by the end of
2020.
- Announced a new clinical program focused on NurOwn as a
treatment for Alzheimer's disease (AD). The Company is planning a
multi-national Phase 2 clinical trial in Europe in patients with prodromal to mild
AD.
- The Alzheimer's disease program and Phase 2 trial were featured
in a Key Opinion Leader (KOL) webinar on July 8.
- Announced groundbreaking pre-clinical study of NurOwn derived
exosome-based treatment for Covid-19 ARDS.
- Granted Small and Medium-Sized Enterprise (SME) status by the
European Medicines Agency
- Announced leasing of three state-of-the-art cleanrooms, at the
Tel Aviv Sourasky Medical Center to increase manufacturing
capability for EU and the local Israeli market
- Awarded $0.5 Million by The ALS
Association and IAMALS for ALS Biomarker Study
- Professor Jacob Frankel
appointed as Chairman of the Board of Directors
- Appointed Stacy R. Lindborg Ph.D. as Executive Vice President,
Head of Global Clinical Research
- Appointed David Setboun as Executive Vice President and Chief
Operating Officer
- Presented new data highlighting NurOwn immunomodulation in
Neurology Journal
- Awarded $1.5 million grant for
2020 by the Israel Innovation Authority
- Received non-dilutive bonus payment of $700,000 from CIRM for treating more California participants than originally
proposed in our Phase 3 ALS clinical trial.
- Joined the Russell 2000® and Russel 3000®
Indexes
Presented at the following Investor Conferences:
- Raymond James Human Health Innovations Conference
- BIO Digital 2020
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
- Cash, cash equivalents, and short-term bank deposits were
approximately $16.2 million as of
June 30, 2020, compared to
$6.2 million on March 31, 2019.
- Research and development expenses, net for the three months
ended June 30, 2020 and 2019 were
$5.69 million and $3.55 million, respectively.
- Excluding participation from IIA and
CIRM under the grants and proceeds received under the hospital
exemption regulatory pathway, research and development expenses
decreased by $520,000 from
$6.54 million in the second quarter
of 2019 to $6.02 million in the
second quarter of 2020.
- General and administrative expenses for the three months ended
June 30, 2020 and 2019 were
$1.71 million and $1.30 million, respectively.
- Net loss for the three months ended June
30, 2020 was $7.39 million, as
compared to a net loss of $4.90
million for the three months ended June 30, 2019.
- Net loss per share for the three months
ended June 30, 2020 and 2019 was
$0.25 and $0.23, respectively.
Conference Call & Webcast
Wednesday, August 5, 2020 at
8am Eastern Time
From the
US: 877-407-9205
International:
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.
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,
|
|
2020
|
|
2019
|
|
U.S. $ in thousands
|
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
|
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,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
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)
|
|
43
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Brainstorm Cell Therapeutics Inc