BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of cellular therapies for neurodegenerative diseases,
announced today financial results for the first quarter ended March
31, 2020 and recent corporate updates.
“While many companies have been greatly hindered
by the COVID-19 pandemic, Brainstorm, due to the incredible
strength of our clinical trial participants, the amazing teams at
our U.S. investigational sites and the talent and commitment of
each and every team member at BrainStorm, the Phase 3 ALS trial
remains on track for a Q4’20 topline data readout.
Participants in the fully enrolled clinical trial in our 6 United
States medical centers of excellence continue to receive their
scheduled treatments with the necessary safety protocols in place,”
stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell
Therapeutics. He added, “We were able to advance our global
footprint by signing an agreement with a senior, leading EMEA
(European Medicines Agency) regulatory consultant who will advise
us as we approach EMEA Regulatory Institutions to present data for
NurOwn in ALS, and the advancement of NurOwn in other disease
indications. Additionally, we entered into a lease agreement with
the Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Tel
Aviv, Israel, to produce NurOwn in three state-of-the-art
cleanrooms. The new facility will significantly increase the
Company’s manufacturing capacity, allowing us to strategically
enter the European and Israeli markets.”
Dr. Ralph Kern, President and Chief Medical
Officer of Brainstorm Cell Therapeutics said, “The COVID-19
pandemic has resulted in delays in the pace of enrollment for our
Phase 2 Progressive MS clinical trial. Scheduled March and April
2020 new participant enrollments were deferred to May 2020 when the
affected healthcare sites anticipate their access restrictions may
be mitigated. We anticipate that enrollment will continue in 2020
subject to any site access restrictions related to COVID-19.
Additionally, we are collecting clinical and biomarker data from
the treated progressive MS participants and plan to perform an
interim analysis after 50% of participants in the trial have been
treated. Our clinical team has maximized this disruptive time to
re-examine our data and make sure our data is pristine for future
regulatory submissions.” Dr. Kern concluded, “In terms of the
Hospital Exemption Program, the Company has not completed treatment
of all the first 13 patients as non-Israeli patients are unable to
travel to Israel at the present time due to COVID-19 travel
restrictions. The Company is currently collecting HE clinical data
for the patients who already received treatment at the Tel Aviv
Sourasky Medical Center. Once the complete data set for the first
13 treated patients is available, we will perform a detailed
analysis.”
First Quarter 2020 and Recent Corporate
Highlights:
- April 3: Awarded $1.5 Million Non-Dilutive Grant for 2020 by
the Israel Innovation Authority
- April 1: Appoints David Setboun as COO; Dr. Ralph Kern promoted
to President
- March 31: Appoints distinguished economist Dr. Jacob Frenkel as
chairman of the board; appoints Mr. Sankesh Abbhi, a seasoned
executive and entrepreneur in life sciences as new board
member
- March 16: Announced receipt of $2.2 million from CIRM for
meeting prespecified milestones
- March 6: Raised gross proceeds of $10 million financing from
Abbhi Investments, LLC in a registered direct offering
- March 6: Enters common stock ATM distribution agreement for up
to $50 million with Raymond James
- February 11: Announced that the Company and FDA agreed to
potential NurOwn® regulatory pathway for approval in ALS and
committed to work collaboratively, including opportunities to
expedite statistical review of data from the Phase 3 trial.
Scientific and Company
Presentations:
- February 17 - Presentation at Noble Capital Markets’ Sixteenth
Annual Investor Conference
- February 11 - Presentation at BIO CEO & Investor
Conference
- January 24 - Podium presentation at the 10th Annual California
ALS Research Summit
- January 12 - Presentation and participation at the Rare &
Orphan Diseases Panel at the 3rd Annual Neuroscience Innovation
Forum
Financial Results for the Three Months
Ended March 31, 2020
- Cash, cash equivalents, and short-term bank deposits were
approximately $14.5 million at March 31, 2020, compared to $6.2
million at March 31, 2019.
- Research and development expenses, net, for the three months
ended March 31, 2020 were $5.95 million, compared to $3.46 million,
net for the three months ended March 31, 2019. - Excluding
participation from IIA and CIRM under the grants and proceeds
received under the Hospital Exemption regulatory pathway, research
and development expenses increased by $1.94 million from $5.20
million in the first quarter of 2019 to $7.14 million in the first
quarter of 2020
- General and administrative expenses for the three months ended
March 31, 2020 were $2.36 million, compared to $1.47 million in the
three months ended March 31, 2019.
- Net loss for the three months ended March 31, 2020 was $8.1
million, or ($0.32) per share, as compared to a net loss of $5.03
million, or ($0.24) per share for the three months ended March 31,
2019.
For further details on BrainStorm’s financials,
including financial results for the three months ended March 31,
2020, refer to Form 10-Q filed with the SEC on May 7th, 2020
Conference Call and Webcast: Thursday, May
7, 2020 @ 8:30 a.m. Eastern Time
U.S. Toll Free: |
877-407-9205 |
|
|
Toll/International: |
201-689-8054 |
|
|
Webcast Link: |
https://www.webcaster4.com/Webcast/Page/2354/34588 |
A teleconference replay of the conference call will be available
for 14 days on the “Investors & Media” page of BrainStorm’s
website:
Toll Free: |
877-481-4010 |
|
|
Toll/International: |
919-882-2331 |
|
|
Replay Passcode: |
34588 |
|
|
Teleconference Replay Expiration: |
Thursday, May 21, 2020 |
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
Media: Sean Leous Westwicke/ICR PR
Phone: +1.646.677.1839 sean.leous@icrinc.com
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE
SHEETSU.S. dollars in
thousands(Except share data)
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2 0 2 0 |
|
|
2 0 1 9 |
|
|
|
U.S. $ in thousands |
|
ASSETS |
|
Unaudited |
|
|
Audited |
|
|
|
|
Current Assets: |
|
|
Cash and cash equivalents |
$ |
12,471 |
|
$ |
536 |
|
Short-term deposit (Note 4) |
|
2,020 |
|
|
33 |
|
Other accounts receivable |
|
435 |
|
|
2,359 |
|
Prepaid expenses and other current assets (Note 5) |
|
279 |
|
|
432 |
|
Total current assets |
|
15,205 |
|
|
3,360 |
|
|
|
|
Long-Term Assets: |
|
|
Prepaid expenses and other long-term assets |
|
31 |
|
|
32 |
|
Operating lease right of use asset (Note 6) |
|
1,917 |
|
|
2,182 |
|
Property and Equipment, Net |
|
918 |
|
|
960 |
|
Total Long-Term Assets |
|
2,866 |
|
|
3,174 |
|
|
|
|
|
|
|
|
|
|
|
Total assets |
$ |
18,071 |
|
$ |
6,534 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
Current Liabilities: |
|
|
Accounts payable |
$ |
4,571 |
|
$ |
14,677 |
|
Accrued expenses |
|
1,303 |
|
|
1,000 |
|
Operating lease liability (Note 6) |
|
1,208 |
|
|
1,263 |
|
Other accounts payable |
|
1,170 |
|
|
714 |
|
Total current liabilities |
|
8,252 |
|
|
17,654 |
|
|
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
Operating lease liability (Note 6) |
|
808 |
|
|
1,103 |
|
Total long-term liabilities |
|
808 |
|
|
1,103 |
|
|
|
|
|
|
|
|
Total liabilities |
$ |
9,060 |
|
$ |
18,757 |
|
|
|
|
Stockholders' Equity (deficit): |
|
|
Stock capital: (Note 7) |
|
12 |
|
|
11 |
|
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares
at March 31, 2020 and December 31, 2019 respectively;
Issued and outstanding: 28,423,837 and
23,174,228 shares at March 31, 2020
and December 31, 2019 respectively. |
|
|
Additional paid-in-capital |
|
134,389 |
|
|
105,042 |
|
Receipts on account of shares |
|
- |
|
|
- |
|
Accumulated deficit |
|
(125,390) |
|
|
(117,276) |
|
Total stockholders' equity (deficit) |
|
9,011 |
|
|
(12,223) |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
18,071 |
|
$ |
6,534 |
|
|
|
|
|
|
|
|
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 2 0 |
|
|
2 0 1 9 |
|
U.S. $ in thousands |
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net |
$ |
5,948 |
|
$ |
3,456 |
General and administrative |
|
2,360 |
|
|
1,472 |
|
|
|
|
|
|
Operating loss |
|
(8,308) |
|
|
(4,928) |
|
|
|
Financial expenses (income), net |
|
(194) |
|
|
99 |
|
|
|
|
|
|
Net loss |
$ |
(8,114) |
|
$ |
(5,027) |
Basic and diluted net loss per share from continuing
operations |
$ |
(0.32) |
|
$ |
(0.24) |
|
|
|
|
|
|
|
Weighted average number of shares outstanding used in computing
basic and diluted net loss per share |
|
28,423,837 |
|
|
20,917,329 |
|
|
|
|
|
|
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Apr 2024 to May 2024
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From May 2023 to May 2024