Filed Pursuant to Rule 424(b)(5)
Registration No. 333-225517
PROSPECTUS SUPPLEMENT
(To Prospectus dated June 29, 2018)

BRAINSTORM CELL THERAPEUTICS INC.
Up to $45,000,000
Common Stock
This prospectus supplement and the accompanying prospectus relate
to the offer and sale from time to time of shares of our common
stock, par value $0.00005 per share, having an aggregate offering
price of up to $45,000,000. Shares of our common stock to which
this prospectus supplement relates may be offered over a period of
time and from time to time through SVB Leerink LLC and Raymond
James & Associates, Inc., as our distribution agents, which we
refer to as our Distribution Agents, for sale to the public in
accordance with the terms of an Amended and Restated Distribution
Agreement we have entered into with the Distribution Agents. Sales
of shares of our common stock, if any, may be made in transactions
that are deemed to be “at-the-market offerings” as defined in Rule
415 under the Securities Act of 1933, as amended, or the Securities
Act, including sales made directly on or through the Nasdaq Capital
Market, sales made to or through a market maker other than on an
exchange, in transactions at market prices prevailing at the time
of sale or at prices related to such market prices, or any other
method permitted by law. Under the terms of the Amended and
Restated Distribution Agreement, we may also sell our common stock
to either of the Distribution Agents as principals for their own
accounts at prices agreed upon at the time of sale. If we sell our
common stock to the Distribution Agents as principals, we will
enter into a separate terms agreement with the Distribution Agents.
The Distribution Agents are not required to sell any specific
dollar amount or number of securities, but will act as the
Distribution Agents using commercially reasonable efforts
consistent with their normal trading and sales practice, on
mutually agreed upon terms between us and the Distribution Agents.
There is no arrangement for funds to be received in any escrow,
trust or similar arrangement.
We previously sold 2,446,641 shares of common stock for gross
proceeds of approximately $23.11 million of common stock under our
Distribution Agreement we previously entered into with Raymond
James & Associates, Inc. pursuant to a prospectus supplement
dated March 6, 2020. We may offer and sell up to an additional
$45,000,000 of common stock through the Distribution Agents
pursuant to this prospectus supplement. Our common stock is listed
on the Nasdaq Capital Market under the symbol “BCLI.” On September
24, 2020, the last reported sale price of our common stock on the
Nasdaq Capital Market was $14.19 per share.
We will pay the Distribution Agents a commission rate equal to 3.0%
of the gross sales price of all shares sold by them as the
Distribution Agents under the Amended and Restated Distribution
Agreement. In connection with the sale of our common stock on our
behalf, the Distribution Agents will be deemed to be “underwriters”
within the meaning of the Securities Act and the compensation of
the Distribution Agents will be deemed to be underwriting
commissions. We have also agreed to provide rights of
indemnification and contribution to the Distribution Agents with
respect to certain liabilities, including liabilities under the
Securities Act.
Investing in our common stock involves a high degree of risk.
Before deciding whether to invest in our common stock, you should
review carefully the risks and uncertainties that are described in
the “Risk Factors” section beginning on page S-10 of this
prospectus supplement, and in the documents incorporated by
reference herein, including our most recent Annual Report on Form
10-K for the fiscal year ended December 31, 2019 as well as the
risks and uncertainties described in the other documents
incorporated herein by reference.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement and the
accompanying prospectus are truthful or complete. Any
representation to the contrary is a criminal offense.
SVB Leerink |
Raymond James
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The date of this prospectus supplement is September 25, 2020
TABLE OF CONTENTS
Prospectus Supplement
ABOUT THIS PROSPECTUS
SUPPLEMENT
On June 8, 2018, we filed with the Securities and Exchange
Commission (the “SEC”) a registration statement on Form S-3 (File
No. 333-225517) using a shelf registration process relating to the
securities described in this prospectus supplement, which
registration statement was declared effective by the SEC on June
29, 2018. Under this shelf registration process, we may offer and
sell, either individually or in combination, in one or more
offerings, common stock, warrants and units, for total gross
proceeds of up to $100 million.
This document consists of two parts. The first part is the
prospectus supplement, which describes the specific terms of this
offering. The second part is the accompanying prospectus, which
provides more general information, some of which may not apply to
the securities offered by this prospectus supplement.
We urge you to read carefully this prospectus supplement, the
accompanying prospectus and any free writing prospectuses we have
authorized for use in connection with this offering, together with
information incorporated by reference in this prospectus supplement
and the accompanying prospectus, before investing in any of the
securities being offered under this prospectus supplement. You
should rely only on the information contained in, or incorporated
by reference into, this prospectus supplement and the accompanying
prospectus, along with the information contained in any free
writing prospectuses we have authorized for use in connection with
this offering. We have not authorized anyone to provide you with
different or additional information. This prospectus supplement is
an offer to sell only the securities offered hereby, but only under
circumstances and in jurisdictions where it is lawful to do so.
The information appearing in this prospectus supplement, the
accompanying prospectus or any related free writing prospectus is
accurate only as of the date on the front of the document and any
information we have incorporated by reference is accurate only as
of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus supplement, the
accompanying prospectus or any related free writing prospectus, or
any sale of a security. Our business, financial condition, results
of operations and prospects may have changed since those dates.
This prospectus supplement and any free writing prospectus that we
have authorized for use in connection with this offering may add,
update or change the information contained in the accompanying
prospectus and the documents incorporated by reference in this
prospectus supplement and the accompanying prospectus. To the
extent that any statement that we make in this prospectus
supplement or any related free writing prospectus is inconsistent
with statements made in the accompanying prospectus or any
documents incorporated by reference into this prospectus supplement
or the related free writing prospectus, as the case may be, you
should rely on the information in this prospectus supplement or the
related free writing prospectus. If any statement in one of these
documents is inconsistent with a statement in another document
having a later date - for example, a document incorporated by
reference in the accompanying prospectus - the statement in the
document having the later date modifies or supersedes the earlier
statement.
We further note that the representations, warranties and covenants
made by us in the Amended and Restated Distribution Agreement or
any other agreement that is filed as an exhibit to any document
that is incorporated by reference in this prospectus supplement and
in the accompanying prospectus were accurate only as of the date
when made. Moreover, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
In this prospectus supplement, unless otherwise expressly stated or
the context otherwise requires, the terms “we,” “us,” “our,”
“Brainstorm” and the “Company” refer to Brainstorm Cell
Therapeutics Inc. and our subsidiaries on a combined basis, except
that in the description of the securities offered, these terms
refer solely to Brainstorm Cell Therapeutics Inc. and not to any of
our subsidiaries.
WHERE YOU CAN FIND MORE
INFORMATION
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. We file these documents with the
SEC electronically. You can access the electronic versions of these
filings on the SEC’s internet website found at
http://www.sec.gov.
This prospectus supplement and the accompanying prospectus omit
some information contained in the registration statement in
accordance with SEC rules and regulations. You should review the
information and exhibits included in the registration statement for
further information about us and the securities offered by us.
Statements in this prospectus supplement and the accompanying
prospectus concerning any document filed as an exhibit to the
registration statement or otherwise filed with the SEC are not
intended to be comprehensive and are qualified by reference to
these filings. You should review the complete document to evaluate
these statements.
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
The SEC’s rules allow us to “incorporate by reference” information
into this prospectus supplement and the accompanying prospectus,
which means that we can disclose important information to you by
referring you to another document filed separately with the SEC.
The information incorporated by reference is deemed to be part of
this prospectus supplement and the accompanying prospectus, and
later information that we file with the SEC will automatically
update and supersede that information. Any statement contained in a
previously filed document incorporated by reference shall be deemed
to be modified or superseded for purposes of this prospectus
supplement to the extent that a statement contained in this
prospectus supplement modifies or replaces that statement.
We incorporate by reference, as of their respective dates of
filing, the documents listed below and any future filings made by
us with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”)
between the date of this prospectus supplement and the termination
of this offering of the securities described in this prospectus
supplement. We are not, however, incorporating by reference any
documents or portions thereof, whether specifically listed below or
filed in the future, that are not deemed “filed” with the SEC.
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Our Annual Report on Form 10-K
for the year ended December 31, 2019, filed with the SEC on
February 18, 2020; |
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Our Quarterly Reports on Form
10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed
with the SEC on May 7, 2020 and August 5, 2020; |
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Our Current Reports on Form 8-K
filed with the SEC on March 6, 2020, March 13, 2020, March 31, 2020, April 3, 2020, June 26, 2020 and September 3, 2020;
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The description of our common stock contained in our registration
statement on Form 8-A, filed with the SEC on
September 24, 2014, including any amendment or report filed for
the purpose of updating such description.
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You may request a free copy of any of the documents incorporated by
reference in this prospectus supplement by writing or telephoning
us at the following address:
Brainstorm Cell Therapeutics
Inc.
1325 Avenue of Americas, 28th Floor
New York, NY 10019
Attention: Chief Executive Officer
(201) 488-0460
These filings and reports can also be found on our website, located
at http://www.brainstorm-cell.com, by following the links to
“Investor Relations” and “SEC Filings.”
The information contained on (or accessible through) our website
does not constitute a part of this prospectus supplement.
SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus, any free
writing prospectus and the documents incorporated herein and
therein by reference may contain forward-looking statements within
the meaning of the federal securities laws. These forward-looking
statements are intended to qualify for the safe harbor from
liability established by the Private Securities Litigation Reform
Act of 1995. All statements other than statements of historical
fact included in this prospectus supplement, the accompanying
prospectus, any free writing prospectus or the documents
incorporated herein or therein by reference, are forward looking
statements. The words “believe,” “may,” “might,” “could,” “will,”
“aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
“plan” and similar words are intended to identify estimates and
forward-looking statements.
Our forward-looking statements are based on our current assumptions
and expectations about future events and trends, which affect or
may affect our business, strategy, operations, financial
performance or prospects. Although we believe that these estimates
and forward-looking statements are based upon reasonable
assumptions, they are subject to numerous known and unknown risks
and uncertainties and are made in light of information currently
available to us. Many important factors may materially and
adversely affect the assumptions and expectations described in the
forward-looking statements. You should read this prospectus
supplement, the accompanying prospectus, any free writing
prospectus, and the documents we incorporate by reference herein
and therein, completely and with the understanding that our actual
future results may be materially different and worse than what we
expect.
Moreover, we operate in an evolving environment. New risk factors
and uncertainties emerge from time to time and it is not possible
for us to predict all risk factors and uncertainties, nor can we
assess the impact of all factors on our business or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements. We qualify all of our forward-looking
statements by these cautionary statements.
The following factors, among others, could cause our financial and
operational performance to differ materially from that expressed in
such forward-looking statements:
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our need to raise additional
capital; |
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our ability to continue as a
going concern; |
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regulatory approval of our
NurOwn® treatment candidate; |
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the success of our product
development programs and research; |
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regulatory and personnel
issues; |
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development of a global market
for our services; |
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the ability to secure and
maintain research institutions to conduct our clinical
trials; |
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the ability to generate
significant revenue; |
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the ability of our NurOwn®
treatment candidate to achieve broad acceptance as a treatment
option for Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou
Gehrig’s disease) or other neurodegenerative diseases; |
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our ability to manufacture and
commercialize our NurOwn® treatment candidate; |
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obtaining patents that provide
meaningful protection; |
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competition and market
developments; |
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our ability to protect our
intellectual property from infringement by third
parties; |
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health reform
legislation; |
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demand for our
services; |
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currency exchange
rates; |
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product liability claims and
litigation; |
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disruptions in our business
(supply chains, workforce availability, disruptions in partnered
medical centers in the United States and Europe, travel
restrictions) due to the novel strain of coronavirus, SARS-CoV-2
(“COVID-19”) outbreak, including our clinical development
activities; and |
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other risks and uncertainties
detailed from time to time in our SEC filings. |
Estimates and forward-looking statements speak only as of the date
they were made, and, except to the extent required by law, we
undertake no obligation to update or to review any estimate and/or
forward-looking statement because of new information, future events
or other factors. Estimates and forward-looking statements involve
risks and uncertainties and are not guarantees of future
performance. As a result of the risks and uncertainties described
herein and in our other SEC filings, the results and outcomes set
forth in the forward-looking statements discussed in this
prospectus supplement, the accompanying prospectus, any free
writing prospectus, and the documents incorporated by reference
herein and therein, might not occur and our future results and our
performance may differ materially from those expressed in these
forward-looking statements due to, but not limited to, the factors
mentioned above. Because of these uncertainties, you should not
place undue reliance on these forward-looking statements when
making an investment decision.
PROSPECTUS SUPPLEMENT
SUMMARY
This summary highlights selected information contained or
incorporated by reference in this prospectus supplement or the
accompanying prospectus and may not contain all the information
that you need to consider in making your investment decision. To
understand this offering fully, you should carefully read this
prospectus supplement, the accompanying prospectus, any free
writing prospectuses we have authorized for use in connection with
this offering and the documents incorporated by reference herein
and therein carefully. In particular, you should carefully read the
sections titled “Risk Factors” in this prospectus supplement and in
the accompanying prospectus and the documents identified in the
section “Incorporation of Certain Documents by Reference.”
Overview
Company Overview
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Brainstorm Cell Therapeutics Inc.
is a leading biotechnology company committed to the development and
commercialization of best-in-class autologous cellular therapies
for the treatment of neurodegenerative diseases including:
Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou Gehrig’s
disease); Progressive Multiple Sclerosis (“PMS”); Alzheimer's
disease ("AD"); and other neurodegenerative diseases. |
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NurOwn® leverages innovative and proprietary cell culture
methods to induce autologous bone marrow-derived mesenchymal stem
cells ("MSCs") to secrete high levels of neurotrophic factors
("NTFs"), modulate neuroinflammatory and neurodegenerative disease
processes, promote neuronal survival and improve neurological
function. |
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Our wholly owned Israeli subsidiary, Brainstorm Cell
Therapeutics Ltd. (“Israeli Subsidiary”), holds exclusive rights to
commercialize NurOwn® technology through a licensing agreement with
Ramot at Tel Aviv University Ltd. (“Ramot”), the technology
transfer company of Tel Aviv University, Israel. |
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The Israeli Subsidiary was granted
approval by the Israeli Ministry of Health (“MoH”) to treat ALS
patients with NurOwn® under the Hospital Exemption Pathway
(“HE”). |
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NurOwn® has a strong and
comprehensive intellectual property portfolio. |
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NurOwn® was granted Fast Track
designation by the U.S. Food and Drug Administration (“FDA”) and
Orphan Drug status by the FDA and the European Medicines Agency
(“EMA”) for ALS. |
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We have been granted Micro, Small
and Medium-Sized Enterprise (“SME”) status by the European
Medicines Agency's (“EMA”) SME office. |
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We currently employ 43 employees in
the United States and in Israel. Most of the senior management team
is based in the United States, and all of Brainstorm’s ongoing
clinical trial sites for ALS and PMS are in the United States. The
clinical trial sites for Brainstorm's AD trial will be in Europe.
Brainstorm’s R&D center is located in Petach Tikva,
Israel. |
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The outbreak of COVID-19 disease
and its impact: |
The outbreak of COVID-19 disease has currently impacted and may
continue to adversely impact our business, including our
preclinical studies and clinical trials. In December 2019, a novel
strain of coronavirus, surfaced in Wuhan, China. Since then,
COVID-19 has spread to multiple countries, including the United
States, Europe and Israel, where the Company conducts its
operations, as well as its clinical trials for NurOwn®. In response
to the spread of COVID-19 and to ensure safety of employees and
continuity of business operations, we closed our offices in the
United States and limited the number of employees working in our
offices in Israel, with our administrative employees continuing
their work remotely. Though we limited the number of staff in any
given research and development laboratory, our research and
development laboratory in Israel and manufacturing sites in U.S.
remain open.
As of the date of this prospectus supplement, our U.S. Phase 2 PMS
clinical trial has continued with slight delays in the pace of
enrollment due to site access restrictions related to the global
COVID-19 pandemic. Scheduled March and April 2020 new patient
enrollments were deferred to May 2020 due to site closures related
to COVID-19. As of June 2020, all the trial sites were prepared to
continue with the trial and as of August 4, 2020, all 20 study
participants have been enrolled in the study. We are currently
collecting the clinical and biomarker data from treated patients.
Dosing of all participants is expected to be completed in the
fourth quarter of 2020. The Phase 3 ALS clinical trial continued to
provide necessary treatments to study participants despite severe
constraints in the affected healthcare institutions due to
COVID-19. As of July 2, 2020, the study completed dosing of all the
participants in the Phase 3 ALS trial. The Phase 3 ALS trial is
expected to generate top-line data by the end of November 2020. We
recently announced a new clinical program focused on the
development of NurOwn® as a treatment for AD. As part of the newly
announced program, we are planning a multi-national Phase 2
clinical trial in Europe to evaluate the safety and efficacy of
NurOwn® treatment in patients with prodromal to mild AD.
Recent Developments
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We have made significant progress
in the past 12 months advancing the NurOwn® ALS Phase 3 clinical
trial at all 6 U.S. investigative sites (Mass General Hospital,
UMass, Mayo Clinic, CPMC, Cedars Sinai and UC Irvine). This
clinical trial builds upon promising efficacy seen in three prior
early-stage ALS clinical trials, including a U.S. randomized
placebo-controlled Phase 2 trial. Enrollment for NurOwn® ALS Phase
3 trial was completed in October 2019 and dosing of all
participants in the trial was completed as of July 2, 2020. The
trial is expected to generate top-line data by the end of November
2020 to support an FDA Biologics License Applications (“BLA”)
filing. |
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On April 3, 2020, we announced that
our wholly owned subsidiary, Brainstorm Cell Therapeutics Ltd., has
been awarded a non-dilutive grant of approximately $1.5 million by
the Israel Innovation Authority. The grant enables us to continue
development of advanced cellular manufacturing capabilities,
furthers the development of MSC-derived exosomes as a novel
therapeutic platform, and will ultimately enable Brainstorm to
expand its therapeutic pipeline in neurodegenerative disorders. As
of June 30, 2020, we have received $583,000 out of the $1.5 million
awarded. |
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On July 1, 2020, we received a
non-dilutive bonus payment of $700,000 from California Institute
for Regenerative Medicine (“CIRM”) for treating more California
participants than originally proposed in our Phase 3 ALS
trial. |
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On July 2, 2020, we announced the
completion of all dosing of participants in its NurOwn® Phase 3 ALS
clinical trial. |
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On July 8, 2020, we hosted a Key
Opinion Leader webinar to discuss NurOwn® Phase 2 AD Program. The
webinar featured presentations by two lead investigators in our
planned European Phase 2 trial: Philip Scheltens, M.D., Ph.D.,
Professor of Cognitive Neurology and Director of the Alzheimer
Centre at the VU University Medical Center in Amsterdam,
Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology
at the Neurological Institute of the Salpétrière University
Hospital in Paris, France. |
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On July 23, 2020, we announced a
groundbreaking pre-clinical study of NurOwn® derived exosome-based
treatment for COVID-19 Acute Respiratory Disease Syndrome.
Intratracheal administration of exosomes extracted from MSC’s using
NurOwn® technology resulted in statistically significant
improvement in multiple lung parameters in a mouse model. With this
study, we have successfully completed our first milestone in
developing an innovative exosome-based platform-technology for the
treatment severe COVID-19 infection. |
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On August 19, 2020, we announced
the publication of a manuscript titled, “Effects of MSC-NTF cells
on T and B regulatory cell function in ALS” in the journal
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. |
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On August 25, 2020, we announced
the acceptance of a clinical abstract documenting an association
between magnetic resonance imaging (“MRI”) measures and functional
improvement in patients with PMS. The data was presented as a
poster on September 11-13 at the eighth joint virtual meeting of
the Americas Committee for Treatment and Research in Multiple
Sclerosis (“ACTRIMS”) and the European Committee for Treatment and
Research in Multiple Sclerosis (“ECTRIMS”). |
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On September 2, 2020, we announced
the appointment of Anthony P. Waclawski, Ph.D. as Executive Vice
President, Global Head of Regulatory Affairs to further strengthen
its regulatory expertise and capabilities as ALS phase 3 clinical
trial nears completion in Q4. Dr. Waclawski is an industry veteran
and a recognized leader in regulatory affairs with over 35 years of
multinational experience in the FDA regulatory approval process,
including BLAs, New Drug Applications (“NDAs”), and FDA Advisory
Committees. |
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On September 16, 2020, we announced
that the Japanese Patent Office (“JPO”) has granted Brainstorm's
Japanese Patent, number: 6,753,887, titled: “Methods of Generating
Mesenchymal Stem Cells which Secrete Neurotrophic Factors.” |
Prior ATM Facility
On March 6, 2020, we entered into a Distribution Agreement (the
“Prior ATM”) with Raymond James & Associates, Inc. (the
“Agent”) providing for the sale, from time to time through the
Agent, of shares of Common Stock having an aggregate offering
amount of up to $50,000,000. We filed a prospectus supplement on
March 6, 2020, with the “SEC” in connection with the Prior ATM.
During the quarter ended June 30, 2020, we sold an aggregate of
1,162,527 shares of Common Stock pursuant to the Prior ATM at an
average price of $6.57 per share, raising gross proceeds of
approximately $7.64 million. Since its inception on March 6, 2020
through the quarter ended June 30, 2020, we sold an aggregate of
1,499,014 shares of Common Stock at an average price of $6.27 per
share, raising gross proceeds of approximately $9.40 million. From
July 1, 2020 through September 24, 2020, the Company sold an
aggregate of 947,627 additional shares of Common Stock pursuant to
the Prior ATM, at an average price of $14.48 per share, raising
additional gross proceeds of approximately $13.71 million.
Corporate Information
We are incorporated under the laws of the State of Delaware. Our
principal executive offices are located at 1325 Avenue of Americas,
28th Floor, New York, NY 10019, and our telephone number
is (201) 488-0460. We also maintain offices at 12 N State Route 17,
Suite 201, Paramus, NJ 07652, and in Petach Tikva, Israel. We
maintain an Internet website at
http://www.brainstorm-cell.com. The information
contained on (or accessible through) our website is not
incorporated into this prospectus supplement or the accompanying
prospectus.
THE OFFERING
Securities offered |
Shares of common stock, par value $0.00005 per share, having an
aggregate gross sales price of up to $45,000,000.
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Manner of offering |
“At the market” offerings that may be made from time to time
through SVB Leerink LLC and Raymond James & Associates, Inc. as
sales agents. See “Plan of Distribution.”
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Use of proceeds |
We intend to use the proceeds of this offering to fund our
operations, which includes, but is not limited to, advancing the
Company's clinical programs, commercial production of the
investigational therapeutic NurOwn® (whether for ALS or other
indications), regulatory, pre-marketing and commercialization
preparation activities of NurOwn® for ALS, working capital and
general corporate purposes.
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Nasdaq Capital Market symbol |
“BCLI”
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Dividend policy |
We have not previously paid cash dividends on our common stock. It
is our current intention to invest our cash flow and earnings in
the growth of our business and, therefore, we do not plan to pay
cash dividends for the foreseeable future. Investors should not
purchase our common stock with the expectation of receiving cash
dividends.
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Risk factors |
This investment involves a high degree of risk. See “Risk Factors”
beginning on page S-10 of this prospectus supplement and other
information included or incorporated by reference herein, as well
as the risks and uncertainties described in the other documents we
file with the SEC, for a discussion of factors you should carefully
consider before deciding to invest in our common stock.
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Unless otherwise indicated, the number of shares of our common
stock to be outstanding immediately after this offering as shown
above is based on 29,669,855 shares of common stock outstanding as
of June 30, 2020 but excluding the following as of such date:
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1,894,340 shares of common stock issuable upon
the exercise of share options outstanding as of June 30, 2020 at a
weighted average exercise price of $4.13 per share; |
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4,724,868 shares of common stock issuable upon
the exercise of warrants outstanding as of June 30, 2020 at a
weighted average exercise price of $6.29 per share; and |
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1,393,410 shares of common stock reserved for
future issuance under our equity incentive plans as of June 30,
2020. |
RISK FACTORS
An investment in our common stock involves a high degree of
risk. Before you invest in our common stock, you should carefully
consider the risk factors set forth below, those risk factors
related to us and our business described in “Item 1A. Risk Factors”
in Part I of our most recent Annual Report on Form 10-K, as
amended, our most recent Quarterly Report on Form 10-Q, any
subsequently filed Quarterly Reports on Form 10-Q and any
subsequently filed Current Reports on Form 8-K, which are
incorporated herein by reference, and those risk factors that may
be included in any applicable prospectus supplement, together with
all of the other information included in this prospectus
supplement, the accompanying base prospectus and the documents we
incorporate by reference, in evaluating an investment in our common
stock. If any of the risks discussed in the foregoing documents
were to occur, our business, financial condition, results of
operations and cash flows could be materially adversely affected.
Please read “Special Note Regarding Forward-Looking
Statements.”
Risks Relating to this Offering and an Investment in Our Common
Stock
The number of shares of our common stock available for future
sale could adversely affect the market price of our common
stock.
We cannot predict whether future issuances of shares of our common
stock or the availability of shares for resale in the open market
will decrease the market price per share of our common stock. We
may sell shares of our common stock under this prospectus
supplement with an aggregate gross offering price of up to
$45,000,000. We may also sell additional shares of our common stock
in the future under the prospectus which accompanies this
prospectus supplement or in other offerings or other acquisitions
we may undertake. Sales of substantial amounts of shares of our
common stock in the public market, or the perception that such
sales might occur, could adversely affect the market price of our
common stock.
Our management will have broad discretion as to the use of
proceeds from this offering. You may not agree with the manner in
which we use the proceeds and our use of those proceeds may not
yield a favorable return on investment.
We intend to use the net proceeds of this offering to advance the
Company’s clinical programs and for working capital and general
corporate purposes. We have not designated the amount of net
proceeds we will use for any particular purpose and our management
will retain broad discretion to allocate the net proceeds of this
offering. The net proceeds may be applied in ways with which some
investors in this offering may not agree. Moreover, our management
may use the net proceeds for corporate purposes that may not
increase our market value or make us more profitable. In addition,
it may take us some time to effectively deploy the net proceeds
from this offering. Until the net proceeds are effectively
deployed, our return on equity and earnings per share may be
negatively impacted. Management’s failure to use the net proceeds
of this offering effectively could have an adverse effect on our
business, financial condition and results of operations.
Share ownership by our officers and directors and certain
agreements may make it more difficult for third parties to acquire
us or effectuate a change of control that might be viewed favorably
by other stockholders.
As of August 31, 2020, our executive officers and directors
beneficially owned, directly or indirectly, in the aggregate,
approximately 22.1% of our common stock. As a result, if our
executive officers and directors were to oppose a third party’s
acquisition proposal for, or a change in control of, the Company,
our executive officers and directors may have sufficient voting
power to be able to block or at least delay such an acquisition or
change in control from taking place, even if other stockholders
would support such a sale or change of control. In addition, a
number of our executive officers have change of control agreements
which could increase the costs and, therefore, lessen the
attractiveness of an acquisition of the Company to a potential
acquiring party.
We may sell additional shares of common stock in the future
which could result in dilution to our stockholders.
As of August 31, 2020, a total of approximately 68.4 million
authorized but unissued shares of our common stock are available
for future sale and issuance by action of our board of directors
alone, including sales of up to $45,000,000 in value of shares of
our common stock under this prospectus supplement. Accordingly, if
we were to sell additional shares in the future, our stockholders
could suffer dilution in their investment in their shares of our
common stock and in their percentage ownership of the Company.
We may issue additional equity securities, or engage in other
transactions which could dilute our book value or affect the
priority of our common stock, which may adversely affect the market
price of our common stock.
Our board of directors may determine from time to time to raise
additional capital by issuing additional shares of our common stock
or other securities. In addition, we may issue additional
securities in connection with future acquisitions we may make. We
are not restricted from issuing additional shares of common stock,
including securities that are convertible into or exchangeable for,
or that represent the right to receive, common stock. We cannot
predict or estimate the amount, timing, or nature of any future
offerings or issuances of additional stock in connection with
acquisitions, or the prices at which such offerings may be
affected. Such offerings could be dilutive to common stockholders.
New investors also may have rights, preferences and privileges that
are senior to, and that adversely affect, our then-current common
stockholders. Additionally, if we raise additional capital by
making additional offerings of debt or securities, upon liquidation
of the Company, holders of our debt securities, and lenders with
respect to other borrowings, will receive distributions of our
available assets prior to the holders of our common stock.
Additional equity offerings may dilute the holdings of our existing
stockholders or reduce the market price of our common stock, or
both. Holders of our common stock are not entitled to preemptive
rights or other protections against dilution.
A failure to maintain effective internal control over
financial reporting could have a material adverse effect on our
business and stock prices.
Although we are not required to obtain or include in our annual
reports on Form 10-K an attestation report from our independent
registered accountants with respect to the effectiveness of our
internal control over financial reporting, like all other public
companies, our Chief Executive Officer and our Chief Financial
Officer are required, annually, to assess, and disclose their
findings in our annual reports on Form 10-K with respect to, the
effectiveness of our internal control over financial reporting in a
manner that meets the requirements of Section 404(a) of the
Sarbanes-Oxley Act. The rules governing the standards that must be
met for our Chief Executive and Chief Financial Officers to assess
and report on the effectiveness of our internal control over
financial reporting are complex and require significant
documentation, testing and possible remediation, which could
significantly increase our operating expenses.
Additionally, if we are unable to maintain the effectiveness of our
internal control over financial reporting in the future, we may be
unable to report our financial results accurately and on a timely
basis. In such an event, investors and clients may lose confidence
in the accuracy and completeness of our financial statements, as a
result of which our liquidity, access to capital markets, and
perceptions of our creditworthiness could be adversely affected and
the market prices of our common stock could decline. In addition,
we could become subject to investigations by the Nasdaq Capital
Market, the SEC or other regulatory authorities, which could
require us to expend additional financial and management resources.
As a result, an inability to maintain the effectiveness of our
internal control over financial reporting in the future could have
a material adverse effect on our business, financial condition,
results of operations and prospects.
If securities or industry analysts do not publish research or
publish inaccurate or unfavorable research about our business, our
stock price and trading volume could decline.
The trading market for our common stock will depend in part on the
research and reports that securities or industry analysts publish
about us or our business. If one or more of the analysts who cover
us downgrade our stock or publish inaccurate or unfavorable
research about our business, our stock price would likely decline.
If one or more of these analysts cease coverage of our company or
fail to publish reports on us regularly, demand for our stock could
decrease, which might cause our stock price and trading volume to
decline.
The shares of our common stock offered under this prospectus
supplement and the accompanying base prospectus may be sold in
"at-the-market" offerings, and investors who buy shares at
different times will likely pay different prices.
Investors who purchase shares under this prospectus supplement and
the accompanying base prospectus at different times will likely pay
different prices, and so may experience different outcomes in their
investment results. We will have discretion, subject to market
demand, to vary the timing, prices, and numbers of shares sold, and
to determine the minimum sales price for shares sold. Investors may
experience declines in the value of their shares as a result of
share sales made in connection with "at-the-market" offerings at
prices lower than the prices they paid.
The actual number of shares we will issue under the
distribution agreement, at any one time or in total, is
uncertain.
Subject to certain limitations in the Amended and Restated
Distribution Agreement and compliance with applicable law, we and
the Distribution Agents may mutually agree to sell shares of our
common stock under a transaction acceptance at any time throughout
the term of the Amended and Restated Distribution Agreement. The
number of shares that are sold by the Distribution Agents after
agreement on the terms of the transaction acceptance will fluctuate
based on the market price of the shares of our common stock during
the sales period and limits we set with the Distribution Agents.
Because the price per share of each share sold will fluctuate based
on the market price of our shares of common stock during the sales
period, it is not possible to predict the number of shares that
will ultimately be issued.
We do not anticipate paying any cash dividends on our common
stock in the foreseeable future. As a result, you will need to sell
your shares of common stock to receive any income or realize a
return on your investment.
To date, we have not paid any cash dividends on our common stock.
We do not anticipate paying any cash dividends on our common stock
in the foreseeable future. We cannot assure you that we would, at
any time, generate sufficient surplus cash that would be available
for distribution to the holders of our common stock as a
dividend.
USE OF PROCEEDS
We may issue and sell shares of our common stock having aggregate
sale proceeds of up to $45,000,000 from time to time. The amount of
proceeds from this offering will depend upon the number of shares
of our common stock sold and the market price at which they are
sold. There can be no assurance that we will be able to sell any
shares under or fully utilize the Amended and Restated Distribution
Agreement with the Distribution Agents as a source of financing.
Because there is no minimum offering amount required as a condition
to close this offering, the actual total public offering amount,
commissions and proceeds to us, if any, are not determinable at
this time.
We intend to use the proceeds of this offering to fund our
operations, which includes, but is not limited to advancing the
Company’s clinical programs, commercial production of the
investigational therapeutic NurOwn® (whether for ALS or other
indications), regulatory, pre-marketing and commercialization
preparation activities of NurOwn® for ALS, working capital and
general corporate purposes. Our expected use of the net proceeds
from this offering is based upon our present plans and business
condition. As of the date of this prospectus supplement, we cannot
predict with certainty all of the particular uses for the net
proceeds to be received upon the completion of this offering or the
amounts that we will actually spend on the uses set forth above.
The amounts and timing of our actual use of proceeds will vary
depending on numerous factors, including the factors described
under the heading “Risk Factors” beginning on page S-10 and under
the heading “Risk Factors” in the prospectus accompanying this
prospectus supplement and our other SEC filings. As a result,
management will retain broad discretion over the allocation of the
net proceeds from this offering, and investors will be relying on
the judgment of our management regarding the application of the net
proceeds.
DILUTION
If you invest in this offering, your ownership interest will be
diluted immediately to the extent of the difference between the
public offering price per share and the as-adjusted net tangible
book value per share of our common stock after giving effect to
this offering. We calculate net tangible book value per share by
dividing the net tangible book value, which is tangible assets less
total liabilities, by the number of outstanding shares of our
common stock. Dilution represents the difference between the amount
per share paid by purchasers of shares in this offering and the net
tangible book value per share of our common stock immediately after
giving effect to this offering. Our net tangible book value as of
June 30, 2020 was approximately ($9.82 million) or ($0.33) per
share.
After giving effect to the sale of our common stock pursuant to
this prospectus supplement and accompanying prospectus in the
aggregate amount of $45.0 million at an assumed offering price of
$15.09 per share (the last reported sale price of our common stock
on September 18, 2020), and after deducting commissions and
estimated aggregate offering expenses payable by us, our net
tangible book value as of June 30, 2020 would have been $53.47
million, or $1.64 per share of common stock. This represents an
immediate increase in the net tangible book value of $1.31 per
share to our existing stockholders and an immediate dilution in net
tangible book value of $13 per share to investors participating in
this offering. The following table illustrates this per share
dilution:
Assumed
offering price per share |
|
|
|
|
|
$ |
15.09 |
|
Net tangible book value per share as of June 30, 2020 |
|
$ |
0.33 |
|
|
|
|
|
Increase in net tangible book value per share attributable to this
offering |
|
$ |
1.31 |
|
|
|
|
|
As-adjusted net tangible book value per share as of June 30, 2020
after giving effect to this offering |
|
|
|
|
|
$ |
1.64 |
|
Dilution per share to new investors purchasing shares in this
offering |
|
|
|
|
|
$ |
13.00 |
|
The table above assumes for illustrative purposes that an aggregate
of 2,982,107 shares of our common stock are sold pursuant to this
prospectus supplement and the accompanying prospectus at a price of
$15.09 per share (the last reported sale price of our common stock
on September 18, 2020), for aggregate gross proceeds of $45.0
million. The shares sold in this offering, if any, will be sold
from time to time at various prices. An increase of $1.00 per share
in the price at which the shares are sold from the assumed offering
price to $16.09 per share, assuming all of our common stock in the
aggregate amount of $45.0 million is sold at that price, would
result in an adjusted net tangible book value per share after the
offering of $1.65 per share and would increase the dilution in net
tangible book value per share to new investors in this offering to
$13.96 per share, after deducting underwriting commissions and
estimated aggregate offering expenses payable by us. A decrease of
$1.00 per share in the price at which the shares are sold from the
assumed offering price to $14.09 per share, assuming all of our
common stock in the aggregate amount of $45.0 million is sold at
that price, would result in an adjusted net tangible book value per
share after the offering of $1.63 per share and would decrease the
dilution in net tangible book value per share to new investors in
this offering to $12.04 per share, after deducting underwriting
commissions and estimated aggregate offering expenses payable by
us. This information is supplied for illustrative purposes
only.
The above discussion and table are based on 29,669,855 shares of
our common stock issued and outstanding as of June 30, 2020 and
excludes the following:
|
· |
1,894,340 shares of common stock issuable upon
the exercise of share options outstanding as of June 30, 2020 at a
weighted average exercise price of $4.13 per share; |
|
· |
4,724,868 shares of common stock issuable upon
the exercise of warrants outstanding as of June 30, 2020 at a
weighted average exercise price of $6.29 per share; and |
|
· |
1,393,410 shares of common stock reserved for
future issuance under our equity incentive plans as of June 30,
2020. |
DIVIDEND POLICY
We have not declared or paid any cash dividends on our capital
stock since our inception. We currently intend to retain future
earnings, if any, to finance the operation and expansion of our
business and do not anticipate paying any cash dividends in the
foreseeable future. Payment of future dividends, if any, will be at
the discretion of our board of directors and will depend on our
financial condition, results of operations, capital requirements,
restrictions contained in current or future financing instruments,
provisions of applicable law and other factors the board deems
relevant.
MATERIAL U.S. FEDERAL TAX
CONSIDERATIONS FOR
NON-U.S. HOLDERS OF COMMON STOCK
The following is a general discussion of certain material U.S.
federal income tax consequences of the ownership and disposition of
our common stock by a beneficial owner that is a "Non-U.S. Holder."
A Non-U.S. Holder means a beneficial owner of our common stock
that, for U.S. federal income tax purposes, is:
|
· |
a non-resident alien
individual; |
|
· |
a foreign corporation or any other foreign organization taxable as
a corporation for U.S. federal income tax purposes; or
|
|
· |
a foreign estate or
trust, the income of which is not subject to U.S. federal income
tax on a net income basis. |
If an entity that is classified as a partnership for U.S. federal
income tax purposes holds our common stock, the U.S. federal income
tax treatment of a partner will generally depend on the status of
the partner and the activities of the partnership. Partnerships
holding our common stock and partners in such partnerships are
urged to consult their own tax advisers regarding the particular
U.S. federal income tax consequences of holding and disposing of
our common stock.
This discussion is based on the Internal Revenue Code of 1986, as
amended (the "Code"), and administrative pronouncements, judicial
decisions and final, temporary and proposed Treasury Regulations,
any of which may be changed subsequent to the date of this
prospectus supplement, possibly retroactively, so as to result in
U.S. federal income tax consequences different from those discussed
below. We have not sought an opinion of counsel with respect to the
statements made and conclusions reached in this discussion. This
discussion does not address all aspects of U.S. federal income
taxation that may be relevant to Non-U.S. Holders in light of their
particular circumstances, including alternative minimum tax and
Medicare contribution tax consequences. It does not address any tax
consequences arising under U.S. federal estate or gift tax laws or
under the laws of any state, local or foreign jurisdiction and is
limited to Non-U.S. Holders that hold our common stock as a capital
asset within the meaning of Section 1221 of the Code.
This discussion also does not consider any specific facts or
circumstances that may apply
to a Non-U.S. holder and does not address the
special tax rules applicable
to particular Non-U.S. holders, such as:
|
· |
Non-U.S. Holders that own, or have owned, actually or
constructively, more than 5% of our common stock, |
|
· |
tax-exempt, governmental or international organizations; |
|
· |
financial institutions; |
|
· |
brokers or dealers in securities; |
|
· |
regulated investment companies; |
|
· |
“controlled foreign corporations,” “passive foreign investment
companies,” and corporations that accumulate earnings to avoid U.S.
federal income tax; |
|
· |
“qualified foreign pension funds” as defined in
Section 897(I)(2) of the Code and entities all of the
interests of which are held by qualified foreign pension
funds; |
|
· |
persons that hold our common stock as part of a straddle,
hedge, conversion transaction, synthetic security or other
integrated investment; |
|
· |
persons subject to special tax accounting rules as a result of
any item of gross income with respect to our common stock being
taken into account in an applicable financial statement; and |
|
· |
former citizens or long-term residents of the United
States. |
You are urged to consult your tax adviser with respect to the
particular tax consequences to you of owning and disposing of our
common stock, including the consequences under the laws of any
state, local or foreign jurisdiction.
Dividends
In general, any distribution we make to a Non-U.S. Holder with
respect to our common stock that constitutes a dividend for U.S.
federal income tax purposes will be subject to withholding tax at a
rate of 30% of the gross amount, unless the Non-U.S. Holder is
eligible for a reduced rate of withholding tax under an applicable
income tax treaty and the Non-U.S. Holder provides certification of
its eligibility for such reduced rate on a properly completed
applicable Internal Revenue Service ("IRS") Form W-8. A Non-U.S.
Holder that is eligible for a reduced rate of withholding tax under
an income tax treaty may obtain a refund or credit of any excess
amounts withheld by filing an appropriate claim for refund with the
IRS. A distribution will constitute a dividend under U.S. federal
income tax principles to the extent of our current or accumulated
earnings and profits as determined for U.S. federal income tax
purposes. Any distribution not constituting a dividend will reduce
the Non-U.S. Holder's adjusted basis in our common stock and, to
the extent it exceeds the holder's adjusted basis, will be treated
as gain from the sale or exchange of such shares.
If a Non-U.S. Holder is engaged in a trade or business in the
United States, and if dividends paid to the Non-U.S. Holder are
effectively connected with the conduct of this trade or business
(and, if an applicable income tax treaty provides, the dividend is
attributable to a permanent establishment or fixed base maintained
by the Non-U.S. Holder in the United States), the Non-U.S. Holder
will not be subject to the withholding tax discussed above if
certain certification requirements are satisfied but instead will
generally be taxed in the same manner as a U.S. person who holds
our common stock. A Non-U.S. Holder can generally satisfy the
certification requirements by delivering a properly executed IRS
Form W-8ECI to claim an exemption from the withholding tax to the
withholding agent. A corporate Non-U.S. Holder receiving
effectively connected dividends may also be subject to an
additional "branch profits tax" imposed at a rate of 30% (or a
lower treaty rate if applicable). A Non-U.S. Holder may obtain a
refund of any excess amounts withheld under these rules if the
Non-U.S. Holder is eligible for a reduced rate of United States
withholding tax and an appropriate claim for refund is timely filed
with the IRS.
Gain on Disposition of Common Stock
Subject to the discussion below regarding backup withholding, a
Non-U.S. Holder will generally not be subject to U.S. federal
income tax on the gain realized on a sale or other disposition of
our common stock unless:
• the gain is effectively connected with a trade or business of the
Non-U.S. Holder in the United States and, if an applicable income
tax treaty provides, the gain is attributable to a permanent
establishment maintained by the Non-U.S. Holder in the United
States;
• the Non-U.S. Holder is an individual present in the U.S. for an
aggregate of 183 days or more during the taxable year of the
disposition and meets certain other conditions; or
• We are or were a "United States real property holding
corporation," as defined in the Code, at any time within the
five-year period preceding the disposition or the Non-U.S. Holder's
holding period, whichever period is shorter, and our common stock
constitutes a "United States real property interest".
If the gain is described in the first bullet point above, the
Non-U.S. Holder will generally be taxed in the same manner as a
U.S. person on the net gain from the disposition of the common
stock, unless an applicable tax treaty provides otherwise. A
corporate Non-U.S. Holder whose gain from dispositions of our
common stock may be effectively connected with its conduct of a
trade or business in the United States may also be subject to an
additional "branch profits tax" imposed at a rate of 30% (or a
lower treaty rate if applicable). Non-U.S. Holders whose gain from
dispositions of our common stock may be effectively connected with
a trade or business in the United States are urged to consult their
own tax advisers with respect to the U.S. federal income tax
consequences of the ownership and disposition of our common stock,
including the possible imposition of a branch profits tax in the
case of a corporate Non-U.S. Holder.
If the gain is described in the second bullet point above, the
Non-U.S. Holder will generally be taxed at a flat rate of 30% (or a
lower treaty rate if applicable) on its gain derived from the sale
or other disposition, which may be offset by U.S.-source losses
from sales or exchanges of other capital assets recognized during
the year.
With respect to the third bullet point, we believe that we are not,
and we do not anticipate becoming, a United States real property
holding corporation. However, if we were to become a United States
real property holding corporation, any gain recognized on a
disposition of our common stock by a Non-U.S. Holder that did not
own (actually or constructively) more than 5% of our common stock
at any time during the shorter of the period the Non-U.S. Holder
held the shares or the five-year period ending on the date of
disposition would not be subject to U.S. federal income tax,
provided that our common stock is "regularly traded on an
established securities market".
Information Reporting Requirements and Backup
Withholding
Information returns will be filed with the IRS in connection with
payments of dividends and the proceeds from a sale or other
disposition of our common stock. These information reporting
requirements apply regardless of whether withholding was reduced or
eliminated by an applicable tax treaty or withholding was not
required because the dividends were effectively connected with a
trade or business in the United States conducted by the Non-U.S.
Holder. Copies of such information returns may also be made
available to the tax authorities of the country in which a Non-U.S.
Holder resides under the provisions of an applicable income tax
treaty or other agreement with such tax authorities.
U.S. backup withholding will generally apply to the payment of
dividends to Non-U.S. Holders unless such Non-U.S. Holders furnish
to the payor a Form W-8BEN or Form W-8BEN-E (or other applicable
form) or otherwise establish an exemption. Backup withholding is
not an additional tax. The amount of any backup withholding from a
payment to a Non-U.S. Holder will generally be allowed as a credit
against such holder's U.S. federal income tax liability and may
entitle such holder to a refund, provided that the required
information is timely furnished to the IRS.
You are urged to consult your tax adviser regarding the application
of backup withholding and information reporting in your particular
circumstances.
Withholdable Payments to Foreign Financial Entities and Certain
Other Foreign Entities
The Foreign Account Tax Compliance Act ("FATCA") imposes a 30% U.S.
withholding tax on certain payments, including dividends on our
common stock, made to a foreign entity if such entity fails to
satisfy certain disclosure and reporting rules that generally
require (i) in the case of a foreign financial institution, that
the entity identify and provide information in respect of financial
accounts with such entity held (directly or indirectly) by U.S.
persons and U.S.-owned foreign entities, and (ii) in the case of a
non-financial foreign entity, that the entity identify and provide
information in respect of substantial U.S. owners of such entity.
While existing Treasury Regulations would also require withholding
on payments of gross proceeds of the sale or other disposition of
our common stock, recently proposed Treasury Regulations eliminate
this requirement, and the Proposed Regulations may be relied upon
by taxpayers until they are finalized. Various other requirements
and exceptions are provided under FATCA and additional requirements
and exceptions may be provided in subsequent guidance. In addition,
the United States has entered into (and may enter into additional)
intergovernmental agreements ("IGAs") with foreign governments
relating to the implementation of, and information sharing under,
FATCA. IGAs may alter one or more of the FATCA information
reporting rules.
You should consult your tax adviser regarding the possible impact
of these rules on your investment in our common stock, and the
entities through which you hold our common stock, including,
without limitation, the process and deadlines for meeting the
applicable requirements to prevent the imposition of this 30%
withholding tax under FATCA.
PLAN OF DISTRIBUTION
We have entered into an Amended and Restated Distribution Agreement
under which we may issue and sell our common stock having an
aggregate sales price of up to $45,000,000 from time to time
through or to SVB Leerink and Raymond James together the
Distribution Agents. Sales of our common stock, if any, may be made
by means of ordinary brokers' transactions on the Nasdaq Capital
Market or otherwise at market prices, in block transactions or as
otherwise agreed with the Distribution Agents.
The Distribution Agents, as sales agents, are not required to sell
any specific number or dollar amount of common stock but will use
commercially reasonable efforts, consistent with their normal
trading and sales practices, to solicit offers to purchase the
common stock upon entering into a transaction notice with us that
will specify the number of common stock to be sold and such other
matters as may be agreed upon by us and the Distribution Agents.
Subject to the terms and conditions of the Amended and Restated
Distribution Agreement, the Distribution Agents will use
commercially reasonable efforts, consistent with their normal
trading and sales practices, to sell on our behalf all of the
designated common stock pursuant to the terms agreed to with us,
which terms will include the number of common stock to be offered
and any minimum price below which sales may not be made. The
obligation of the Distribution Agents under the Amended and
Restated Distribution Agreement to sell shares pursuant to any
transaction notice is subject to a number of conditions, which the
Distribution Agents reserves the right to waive in their sole
discretion.
The Distribution Agents, in their capacity as sales agents, may
arrange for or make sales at the market in the existing trading
market for our common stock, including sales made to or through a
market maker or through an electronic communications network, or in
any other manner that may be deemed to be an “at-the-market”
offering as defined in Rule 415 promulgated under the Securities
Act. If agreed to in a separate terms agreement, we may also sell
common stock to each of the Distribution Agents as principals, at a
purchase price agreed upon by the Distribution Agents and us. We or
the Distribution Agents may suspend the offering of common stock
upon notice and subject to other conditions.
We will pay the Distribution Agents a commission equal to 3.0% of
the gross sales price of any such shares sold through them as sales
agents, or purchased by them as principals, as set forth in the
Amended and Restated Distribution Agreement. The remaining sales
proceeds, after deducting any transaction fees imposed by any
governmental or self-regulatory organization in connection with the
sales, will equal our net proceeds for the sale of the common
stock. We also have agreed to reimburse the Distribution Agents for
all fees and expenses of counsel for the Distribution Agents, of up
to $50,000, as provided in the Amended and Restated Distribution
Agreement.
Settlement for sales of common stock will occur on the second
business day following the date on which any sales are made in
return for payment of the net proceeds to us. There is no
arrangement for funds to be received in an escrow, trust or similar
arrangement. We will report at least quarterly the number of shares
of common stock sold through the Distribution Agents, as agents, in
at-the-market offerings and the gross and net proceeds to us.
For certain periods before and after any sale transactions under
the Amended and Restated Distribution Agreement, we will not offer
to sell, sell, contract to sell, grant any option to sell or
dispose of, directly or indirectly, any of our common stock or any
securities convertible into or exercisable, redeemable or
exchangeable for such shares or (ii) enter into any swap or other
agreement that transfers, in whole or in part, any of the economic
consequences of ownership of such shares, whether any such
transaction described in clause (i) or, without the prior written
consent of the Distribution Agents, other than the shares to be
sold pursuant to the Amended and Restated Distribution Agreement
and shares issued upon the exercise or conversion of any of our
securities, convertible securities, options or rights outstanding
at the beginning of such period or any grants of options or awards
or securities issued pursuant to existing stock-based compensation
plans.
EXPERTS
The financial statements of the Company as included in our Annual
Report on Form 10-K for the year ended December 31, 2019, are
incorporated herein by reference in reliance on the report of
Brightman, Almagor Zohar & Co., Certified Public Accountants, a
firm in the Deloitte Global Network, an independent registered
public accounting firm, given on the authority of said firm as
experts in auditing and accounting.
LEGAL MATTERS
The validity of the securities being offered hereby will be passed
upon by our legal counsel, Goodwin Procter LLP, Boston,
Massachusetts. Certain legal matters will be passed upon for the
Distribution Agents by Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., New York, N.Y.
PROSPECTUS
BRAINSTORM CELL
THERAPEUTICS INC.
$100,000,000
Common Stock
Warrants
Units
This prospectus relates to common stock, warrants and units that we
may sell from time to time in one or more offerings up to a total
dollar amount of $100,000,000 on terms to be determined at the time
of sale. We will provide specific terms of these securities in
supplements to this prospectus. You should read this prospectus and
any supplement carefully before you invest. This prospectus may not
be used to offer and sell securities unless accompanied by a
prospectus supplement for those securities.
Our common stock is traded on the Nasdaq Capital Market under the
symbol “BCLI.” On June 7, 2018, the last reported sales price
of our common stock was $4.71 per share.
These securities may be sold directly by us, through dealers or
agents designated from time to time, to or through underwriters or
through a combination of these methods. See “Plan of Distribution”
in this prospectus. We may also describe the plan of distribution
for any particular offering of these securities in any applicable
prospectus supplement. If any agents, underwriters or dealers are
involved in the sale of any securities in respect of which this
prospectus is being delivered, we will disclose their names and the
nature of our arrangements with them in a prospectus supplement.
The net proceeds we expect to receive from any such sale will also
be included in a prospectus supplement.
Investing in our securities involves a high degree of risk.
Beginning on page 2, we discuss several “Risk Factors” that
you should consider before investing in our securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is June 29, 2018.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed
with the Securities and Exchange Commission, or the SEC, using a
“shelf” registration process. Under this shelf registration
process, we may sell any combination of the securities described in
this prospectus in one or more offerings up to a total dollar
amount of $100,000,000. This prospectus provides you with a general
description of the securities we may offer. Each time we sell
securities, we will provide a prospectus supplement that will
contain specific information about the securities being offered and
the terms of that offering. The prospectus supplement may also add
to, update or change information contained in this prospectus. You
should read both this prospectus and any prospectus supplement
together with the additional information described under the
heading “Where You Can Find More Information” carefully before
making an investment decision.
You should rely only on the information contained or incorporated
by reference in this prospectus or any applicable prospectus
supplement. We have not authorized any other person to provide you
with different information. If anyone provides you with different
or inconsistent information, you should not rely on it. We are not
making an offer to sell these securities in any jurisdiction where
the offer or sale is not permitted.
You should not assume that the information appearing in this
prospectus or any applicable prospectus supplement is accurate as
of any date other than the date on the front cover of this
prospectus or the applicable prospectus supplement, or that the
information contained in any document incorporated by reference is
accurate as of any date other than the date of the document
incorporated by reference, regardless of the time of delivery of
this prospectus or any prospectus supplement or any sale of a
security. Our business, financial condition, results of operations
and prospects may have changed since such dates.
Unless the context otherwise requires, the terms “Brainstorm,” “the
Company,” “our company,” “we,” “us,” “our” and similar names refer
collectively to Brainstorm Cell Therapeutics Inc. and its
subsidiaries.
ABOUT BRAINSTORM CELL
THERAPEUTICS INC.
Brainstorm Cell Therapeutics Inc. is a biotechnology company
committed to bring innovative Central Nervous System (“CNS”) adult
stem cell therapies to the market to improve the lives of patients
with debilitating neurodegenerative diseases. As a leader in CNS
regenerative cellular medicines, Brainstorm is leveraging NurOwn®,
its proprietary autologous mesenchymal stem cell platform
technology, a strong and expanded IP portfolio, as well as
manufacturing and commercialization capabilities, to address
growing unmet medical needs across a broad range of
neurodegenerative disorders, such as Amyotrophic Lateral Sclerosis
(“ALS”, also known as Lou Gehrig’s disease), Multiple Sclerosis
(“MS”), Parkinson’s disease (“PD”) and Autism Spectrum Disorders
(“ASD”). The NurOwn® proprietary technology is fully licensed
to and developed by Brainstorm Cell Therapeutics Ltd., our
wholly-owned subsidiary (the “Israeli Subsidiary”).
NurOwn® technology is based on an innovative manufacturing
protocol, which induces the differentiation of bone marrow-derived
mesenchymal stem cells (“MSC”) into cells capable of releasing high
levels of multiple neurotrophic factors (“MSC-NTF” cells) for
neuroprotection while maintaining the immunodulatory effects of MSC
cells. These factors are known to be critical for the growth,
survival and differentiation of neurons, they include:
glial-derived neurotrophic factor (“GDNF”); brain-derived
neurotrophic factor (“BDNF”); vascular endothelial growth factor
(“VEGF”); and hepatocyte growth factor (“HGF”). GDNF is one
of the most potent survival factors known for peripheral neurons.
VEGF and HGF have been demonstrated to have important
neuro-protective effects in ALS and in other neurodegenerative
diseases.
Our approach to the treatment of neurodegenerative diseases with
autologous adult stem cells includes a multi-step process that
includes: harvesting of undifferentiated stem cells from the
patient's own bone marrow; processing of cells at the manufacturing
site and cryopreservation to enable multiple treatments from a
single bone marrow sample; and intrathecal (“IT”) injection of
MSC-NTF cells into the same patient by standard lumbar puncture.
This procedure does not require hospitalization and has been shown
to be safe and well tolerated in multiple CNS clinical trials to
date. The ongoing US Phase 3 ALS study is evaluating the
therapeutic potential of repeated dosing (every 2 months).
The proprietary technology and manufacturing processing of NurOwn®
(MSC-NTF cells) for clinical use is conducted in full compliance
with current Good Manufacturing Practice (“cGMP”).
The NurOwn® Transplantation Process includes:
|
· |
Bone marrow
aspiration from patient; |
|
· |
Isolation and propagation of the
mesenchymal stem cells (MSC); |
|
· |
Cryopreservation of
MSC; |
|
· |
Thawing and differentiation of
the MSC into neurotrophic-factor secreting (MSC-NTF; NurOwn®)
cells; and |
|
· |
Autologous transplantation into
the patient’s cerebrospinal fluid by IT injection (lumbar
puncture). |
The ability to induce differentiation of autologous adult
mesenchymal stem cells into MSC-NTF
cells before transplantation is unique to NurOwn®,
making it the first-of-its-kind for the treatment of
neurodegenerative diseases.
The specialized MSC-NTF cells secrete multiple neurotrophic factors
that may lead to:
|
· |
Protection of existing motor neurons; |
|
· |
Promotion of motor neuron repair;
and |
|
· |
Re-establishment of functional
nerve-muscle interaction. |
The NurOwn® approach is autologous, using the patient’s own
bone-marrow derived stem cells for “self-transplantation”. In
autologous transplantation, there is no risk of rejection or
introduction of donor antigens and no need for treatment with
immunosuppressive agents, which can cause severe and/or long-term
side effects. In addition, the use of adult stem cells is free of
ethical controversies associated with the use of embryonic-derived
stem cells in some countries.
NurOwn® is currently in a Phase 3 late stage clinical development
program for the treatment of ALS. It has been granted Fast Track
designation by the U.S. Food and Drug Administration (“FDA”) for
this indication, and has been granted Orphan Status, which provides
the potential for an extended period of exclusivity, in both the
United States and in Europe. We have completed two early stage
clinical trials of NurOwn® in patients with ALS at the Hadassah
Medical Center (“Hadassah”) in Jerusalem as well as a Phase 2
double-blind, placebo-controlled, clinical study at three
prestigious US medical centers, all highly experienced in the
management and investigation of ALS.
We are incorporated under the laws of the State of Delaware. Our
principal executive offices are located at 1745 Broadway, 17th
Floor, New York, NY 10019, and our telephone number is
(201) 488-0460. We maintain a website
at http://www.brainstorm-cell.com. The information on
our website is not incorporated by reference into this prospectus
and should not be considered to be part of this prospectus.
RISK FACTORS
Investing in our securities involves significant risks. Please see
the risk factors under the heading “Risk Factors” in our most
recent Annual Report on Form 10-K, as revised or supplemented by
our Quarterly Reports on Form 10-Q filed with the SEC since the
filing of our most recent Annual Report on Form 10-K, each of which
are on file with the SEC and are incorporated by reference in this
prospectus. Before making an investment decision, you should
carefully consider these risks as well as other information we
include or incorporate by reference in this prospectus and any
prospectus supplement. The risks and uncertainties we have
described are not the only ones facing our company. Additional
risks and uncertainties not presently known to us or that we
currently deem immaterial may also affect our business
operations.
WHERE YOU CAN FIND MORE
INFORMATION
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy any materials
we have filed with the SEC at the SEC’s Public Reference Room at
100 F Street, N.E., Washington, D.C. 20549. You may obtain
information on the operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet
site that contains reports, proxy and information statements, and
other information regarding issuers that file electronically with
the SEC. Our SEC filings are also available to you on the SEC’s
Internet site at www.sec.gov.
This prospectus is part of a registration statement that we filed
with the SEC. This prospectus does not contain all of the
information included in the registration statement, including
certain exhibits and schedules. You can obtain a copy of the
registration statement and exhibits from the SEC at the address
listed above or from the SEC’s Internet site.
Our Internet address
is www.brainstorm-cell.com. The information
on our Internet website is not incorporated by reference in this
prospectus or any prospectus supplement.
SPECIAL NOTE REGARDING
FORWARD-LOOKING INFORMATION
This prospectus and each prospectus supplement includes and
incorporates forward-looking statements within the meaning of the
federal securities laws. These forward-looking statements are based
on management’s beliefs and assumptions. In addition, other written
or oral statements that constitute forward-looking statements are
based on current expectations, estimates and projections about the
industry and markets in which we operate and statements may be made
by or on our behalf. Words such as “may,” “will,” “should,”
“could,” “expects,” “hopes,” “anticipates,” “believes,” “intends,”
“plans,” “estimates,” “predicts,” “likely,” “potential,” or
“continue” or the negative of any of these terms or similar words
and expressions are intended to identify such forward-looking
statements. These statements are not guarantees of future
performance and involve certain risks, uncertainties and
assumptions that are difficult to predict. There are a number of
important factors that could cause our actual results to differ
materially from those indicated by such forward-looking
statements. Forward-looking statements include, but are not
limited to, statements about potential future business operations
and performance, including statements regarding the market
potential for treatment of neurodegenerative disorders such as ALS,
the sufficiency of our existing capital resources for continuing
operations in 2018, the safety and clinical effectiveness of our
NurOwn® technology, our clinical trials of NurOwn® and its related
clinical development, and our ability to develop collaborations and
partnerships to support our business plan. These statements reflect
our views with respect to future events as of the date of this
prospectus and any accompanying prospectus supplement and are based
on assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. These forward-looking statements
represent our estimates and assumptions only as of the date of this
prospectus and any accompanying prospectus supplement and, except
as required by law, we undertake no obligation to update or review
publicly any forward-looking statements, whether as a result of new
information, future events or otherwise after the date of this
prospectus and any accompanying prospectus supplement. We
anticipate that subsequent events and developments will cause our
views to change. We have included important factors in the
cautionary statements included or incorporated in this prospectus
and any accompanying prospectus supplement, particularly under the
heading “Risk Factors,” that we believe could cause actual results
or events to differ materially from the forward-looking statements
that we make. Our forward-looking statements do not reflect the
potential impact of any future acquisitions, merger, dispositions,
joint ventures or investments we may undertake. We qualify all of
our forward-looking statements by these cautionary statements.
INCORPORATION OF CERTAIN
INFORMATION BY REFERENCE
The SEC allows us to “incorporate” into this prospectus information
and reports that we file with the SEC. This means that we can
disclose important information to you by referring to other
documents that contain that information. Any information that we
incorporate by reference is considered part of this prospectus. The
documents and reports that we list below are incorporated by
reference into this prospectus, other than any portion of any such
documents that are not deemed “filed” under the Exchange Act in
accordance with the Exchange Act and applicable SEC rules.
In addition, all documents and reports which we file pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after
the date of this prospectus and prior to the termination of the
offering made hereby are incorporated by reference in this
prospectus as of the respective filing dates of these documents and
reports.
We have filed the following documents with the SEC. These documents
are incorporated herein by reference as of their respective dates
of filing:
|
(2) |
Our
Quarterly Report on Form 10-Q for the quarter ended
March 31, 2018; |
|
(4) |
All
of our filings pursuant to the Exchange Act after the date of
filing the initial registration statement and prior to the
effectiveness of the registration statement; and |
|
(5) |
The
description of our common stock contained in our Registration
Statement on Form 8-A filed on
September 24, 2014, including any amendments or reports filed
for the purpose of updating such description. |
You may request a copy of these documents, which will be provided
to you at no cost, by writing or telephoning us at:
Brainstorm Cell Therapeutics
Inc.
1745 Broadway, 17th Floor
New York, NY 10019
Attention: Chief Executive Officer
(201) 488-0460
Statements contained in documents that we file with the SEC and
that are incorporated by reference in this prospectus will
automatically update and supersede information contained in this
prospectus, including information in previously filed documents or
reports that have been incorporated by reference in this
prospectus, to the extent the new information differs from or is
inconsistent with the old information. Any statement so modified or
superseded will not be deemed to be a part of this prospectus or
any prospectus supplement, except as so modified or superseded.
Because information that we later file with the SEC will update and
supersede previously incorporated information, you should look at
all of the SEC filings that we incorporate by reference to
determine if any of the statements in this prospectus or any
prospectus supplement or in any documents previously incorporated
by reference have been modified or superseded.
USE OF PROCEEDS
We currently intend to use the estimated net proceeds from the sale
of these securities for general corporate purposes, which may
include the following:
|
· |
the research,
development and clinical trials for our treatments; |
|
· |
pursuing
growth initiatives; |
|
· |
any
other purpose that we may specify in any prospectus
supplement. |
We have not yet determined the amount of net proceeds to be used
specifically for any of the foregoing purposes. Accordingly, our
management will have significant discretion and flexibility in
applying the net proceeds from the sale of these securities.
Pending any use, as described above, we intend to invest the net
proceeds in high-quality, short-term, interest-bearing securities.
Our plans to use the estimated net proceeds from the sale of these
securities may change, and if they do, we will update this
information in a prospectus supplement.
THE SECURITIES WE MAY
OFFER
The descriptions of the securities contained in this prospectus,
together with the applicable prospectus supplements, summarize the
material terms and provisions of the various types of securities
that we may offer. We will describe in the applicable prospectus
supplement relating to any securities the particular terms of the
securities offered by that prospectus supplement. If we so indicate
in the applicable prospectus supplement, the terms of the
securities may differ from the terms we have summarized below. We
will also include in the prospectus supplement information, where
applicable, about material United States federal income tax
considerations relating to the securities, and the securities
exchange, if any, on which the securities will be listed.
We may sell from time to time, in one or more offerings:
|
· |
warrants
to purchase common stock or units; |
|
· |
units
comprised of common stock and warrants; or |
|
· |
any
combination of the foregoing securities. |
In this prospectus, we refer to the common stock, warrants and
units collectively as “securities.” The total dollar amount of all
securities that we may issue will not exceed $100,000,000.
This prospectus may not be used to consummate a sale of securities
unless it is accompanied by a prospectus supplement.
DESCRIPTION OF COMMON
STOCK
The following is a summary of all material characteristics of our
common stock as set forth in our certificate of incorporation and
bylaws. The summary does not purport to be complete and is
qualified in its entirety by reference to our certificate of
incorporation and bylaws, and, to the extent applicable, to the
provisions of the Delaware General Corporation Law.
We are authorized to issue 100,000,000 shares of common stock,
$0.00005 par value. As of June 7, 2018, there were
20,249,526 shares of our common stock issued and outstanding, held
by approximately 43 record holders.
The holders of common stock are entitled to one vote per share on
all matters to be voted upon by stockholders, including the
election of directors. The holders of common stock do
not have any cumulative voting, conversion, redemption or
preemptive rights. The holders of common stock are
entitled to receive ratably dividends as may be declared from time
to time by our Board of Directors out of funds legally available
for that purpose. In the event of our liquidation,
dissolution, or winding up, the holders of common stock are
entitled to share ratably in our assets available for distribution
to such holders. All issued and outstanding shares of
common stock are fully paid and non-assessable.
Anti-Takeover Provisions of Delaware Law
We are subject to Section 203 of the Delaware General Corporation
Law, which prohibits a publicly-held Delaware corporation from
engaging in a “business combination,” except under certain
circumstances, with an “interested stockholder” for a period of
three years following the date such person became an “interested
stockholder” unless:
|
· |
before such person became an
interested stockholder, the board of directors of the corporation
approved either the business combination or the transaction that
resulted in the interested stockholder becoming an interested
stockholder; |
|
· |
upon the consummation of the
transaction that resulted in the interested stockholder becoming an
interested stockholder, the interested stockholder owned at least
85% of the voting stock of the corporation outstanding at the time
the transaction commenced, excluding shares held by directors who
also are officers of the corporation and shares held by employee
stock plans; or |
|
· |
at or following the time such
person became an interested stockholder, the business combination
is approved by the board of directors of the corporation and
authorized at a meeting of stockholders by the affirmative vote of
the holders of 66 2/3% of the outstanding voting stock of the
corporation which is not owned by the interested
stockholder. |
The term “interested stockholder” generally is defined as a person
who, together with affiliates and associates, owns, or, within the
three years prior to the determination of interested stockholder
status, owned, 15% or more of a corporation’s outstanding voting
stock. The term “business combination” includes mergers, asset or
stock sales and other similar transactions resulting in a financial
benefit to an interested stockholder. Section 203 makes it more
difficult for an “interested stockholder” to effect various
business combinations with a corporation for a three-year period.
The existence of this provision would be expected to have an
anti-takeover effect with respect to transactions not approved in
advance by our Board of Directors, including discouraging attempts
that might result in a premium over the market price for the shares
of common stock held by stockholders.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American
Stock Transfer & Trust Company LLC.
Nasdaq Capital Market
Our common stock is traded on the Nasdaq Capital Market under the
trading symbol “BCLI.”
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of common stock or units.
Warrants may be issued independently or together with common stock
or units, and the warrants may be attached to or separate from such
securities. We may issue warrants directly or under a warrant
agreement to be entered into between us and a warrant agent. We
will name any warrant agent in the applicable prospectus
supplement. Any warrant agent will act solely as our agent in
connection with the warrants of a particular series and will not
assume any obligation or relationship of agency or trust for or
with any holders or beneficial owners of warrants.
The following is a description of the general terms and provisions
of any warrants we may issue and may not contain all the
information that is important to you. You can access complete
information by referring to the applicable prospectus supplement.
In the applicable prospectus supplement, we will describe the terms
of the warrants and any applicable warrant agreement, including,
where applicable, the following:
|
· |
the title of the
warrants; |
|
· |
the offering price and
aggregate number of warrants offered; |
|
· |
the designation and
terms of the securities with which the warrants are issued and the
number of warrants issued with each such security; |
|
· |
the date on and after
which the warrants and the related securities will be separately
transferable; |
|
· |
any information with
respect to book-entry procedures; |
|
· |
in the case of warrants
to purchase common stock or units, the number of shares of common
stock or units, as the case may be, purchasable upon the exercise
of one warrant and the price at which these securities may be
purchased upon such exercise; |
|
· |
the effect of any
merger, consolidation, sale or other disposition of our business on
the warrant agreement and the warrants; |
|
· |
the terms of any rights
to redeem or call the warrants; |
|
· |
any provisions for
changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants; |
|
· |
the dates on which the
right to exercise the warrants will commence and
expire; |
|
· |
the manner in which the
warrant agreement and warrants may be modified; |
|
· |
a discussion of any
material U.S. federal income tax considerations of holding or
exercising the warrants; |
|
· |
the terms of the
securities issuable upon exercise of the warrants; and |
|
· |
any other specific
terms, preferences, rights or limitations of or restrictions on the
warrants. |
DESCRIPTION OF UNITS
The following description, together with the additional information
we include in any applicable prospectus supplement, summarizes the
material terms and provisions of the units that we may offer under
this prospectus. Units may be offered independently or together
with common stock and warrants offered by any prospectus
supplement, and may be attached to or separate from those
securities.
While the terms we have summarized below will generally apply to
any future units that we may offer under this prospectus, we will
describe the particular terms of any series of units that we may
offer in more detail in the applicable prospectus supplement. The
terms of any units offered under a prospectus supplement may differ
from the terms described below.
We will incorporate by reference into the registration statement of
which this prospectus is a part the form of unit agreement,
including a form of unit certificate, if any, that describes the
terms of the series of units we are offering before the issuance of
the related series of units. The following summaries of material
provisions of the units and the unit agreements are subject to, and
qualified in their entirety by reference to, all the provisions of
the unit agreement applicable to a particular series of units. We
urge you to read the applicable prospectus supplements related to
the units that we sell under this prospectus, as well as the
complete unit agreements that contain the terms of the units.
We may issue units, in one or more series, consisting of common
stock and warrants. Each unit will be issued so that the holder of
the unit is also the holder of each security included in the unit.
Thus, the holder of a unit will have the rights and obligations of
a holder of each included security. The unit agreement under which
a unit is issued may provide that the securities included in the
unit may not be held or transferred separately, at any time, or at
any time before a specified date.
We will describe in the applicable prospectus supplement the terms
of the series of units, including the following:
|
· |
the title of the
units; |
|
· |
the aggregate number of
units; |
|
· |
the price or prices at
which the units will be issued; |
|
· |
the designation and
terms of the units and of the securities comprising the units,
including whether and under what circumstances those securities may
be held or transferred separately; |
|
· |
the effect of any
merger, consolidation, sale or other transfer of our business on
the units and the applicable unit agreement; |
|
· |
the name and address of
any unit agent; |
|
· |
the terms of the
governing unit agreement; |
|
· |
any applicable material
U.S. Federal income tax consequences; and |
|
· |
any provisions for the
issuance, payment, settlement, transfer or exchange of the units or
of the securities comprising the units. |
The provisions described in this section, as well as those
described under “Description of Common Stock,” and “Description of
Warrants,” will apply to each unit and to the common stock and
warrants included in each unit, respectively.
PLAN OF DISTRIBUTION
We may sell the securities being offered hereby in one or more of
the following ways from time to time:
|
· |
through agents to the
public or to investors; |
|
· |
to one or more
underwriters or dealers for resale to the public or to
investors; |
|
· |
in “at the market
offerings,” within the meaning of Rule 415(a)(4) of the Securities
Act, to or through a market maker or into an existing trading
market, or an exchange or otherwise; or |
|
· |
through a combination of
any of these methods of sale. |
The securities that we distribute by any of these methods may be
sold, in one or more transactions, at:
|
· |
a fixed price or prices,
which may be changed; |
|
· |
market prices prevailing
at the time of sale; |
|
· |
prices related to
prevailing market prices; or |
We will set forth in a prospectus supplement the terms of the
offering of our securities, including:
|
· |
the name or names of any
agents or underwriters; |
|
· |
the purchase price of
our securities being offered and the proceeds we will receive from
the sale; |
|
· |
any over-allotment
options under which underwriters may purchase additional securities
from us; |
|
· |
any agency fees or
underwriting discounts and commissions and other items constituting
agents’ or underwriters’ compensation; |
|
· |
any public offering
price; |
|
· |
any discounts or
concessions allowed or reallowed or paid to dealers;
and |
|
· |
any securities exchanges
on which such securities may be listed. |
Underwriters
Underwriters, dealers and agents that participate in the
distribution of the securities may be underwriters as defined in
the Securities Act and any discounts or commissions they receive
from us and any profit on their resale of the securities may be
treated as underwriting discounts and commissions under the
Securities Act. We will identify in the applicable prospectus
supplement any underwriters, dealers or agents and will describe
their compensation. In no event will the aggregate value of
compensation received or to be received by Financial Industry
Regulatory Authority members or independent broker-dealers exceed
8% for the sale of the securities registered hereunder. We may have
agreements with the underwriters, dealers and agents to indemnify
them against specified civil liabilities, including liabilities
under the Securities Act. Underwriters, dealers and agents may
engage in transactions with or perform services for us or our
subsidiaries in the ordinary course of their businesses.
If we use underwriters for a sale of securities, the underwriters
will acquire the securities for their own account. The underwriters
may resell the securities in one or more transactions, including
negotiated transactions, at a fixed public offering price or at
varying prices determined at the time of sale. The obligations of
the underwriters to purchase the securities will be subject to the
conditions set forth in the applicable underwriting agreement. The
underwriters will be obligated to purchase all the securities
offered if they purchase any of the securities offered. We may
change from time to time any initial public offering price and any
discounts or concessions the underwriters allow or reallow or pay
to dealers. We may use underwriters with whom we have a material
relationship. We will describe in the prospectus supplement naming
the underwriters the nature of any such relationship.
If indicated in the applicable prospectus supplement, we will
authorize underwriters or other persons acting as our agents to
solicit offers by particular institutions to purchase securities
from us at the public offering price set forth in such prospectus
supplement pursuant to delayed delivery contracts providing for
payment and delivery on the date or dates stated in such prospectus
supplement. Each delayed delivery contract will be for an amount no
less than, and the aggregate principal amounts of securities sold
under delayed delivery contracts shall be not less nor more than,
the respective amounts stated in the applicable prospectus
supplement. Institutions with which such contracts, when
authorized, may be made include commercial and savings banks,
insurance companies, pension funds, investment companies,
educational and charitable institutions and others, but will in all
cases be subject to our approval. The obligations of any purchaser
under any such contract will be subject to the conditions that
(a) the purchase of the securities shall not at the time of
delivery be prohibited under the laws of any jurisdiction in the
United States to which the purchaser is subject, and (b) if
the securities are being sold to underwriters, we shall have sold
to the underwriters the total principal amount of the securities
less the principal amount thereof covered by the contracts. The
underwriters and such other agents will not have any responsibility
in respect of the validity or performance of such contracts.
Agents
We may designate agents who agree to use their reasonable efforts
to solicit purchases for the period of their appointment or to sell
securities on a continuing basis.
Direct Sales
We may also sell securities directly to one or more purchasers
without using underwriters or agents. We may also make direct sales
through subscription rights distributed to our shareholders on a
pro rata basis, which may or may not be transferable. In any
distribution of subscription rights to shareholders, if all of the
underlying securities are not subscribed for, we may then sell the
unsubscribed securities directly to third parties or may engage the
services of one or more underwriters, dealers or agents, including
standby underwriters, to sell the unsubscribed securities to third
parties.
Trading Markets and Listing of Securities
Unless otherwise specified in the applicable prospectus supplement,
each class or series of securities will be a new issue with no
established trading market, other than our common stock, which is
listed on the Nasdaq Capital Market. We may elect to list any other
class or series of securities on any exchange, but we are not
obligated to do so. It is possible that one or more underwriters
may make a market in a class or series of securities, but the
underwriters will not be obligated to do so and may discontinue any
market making at any time without notice. We cannot give any
assurance as to the liquidity of the trading market for any of the
securities.
Stabilization Activities
In connection with an offering, an underwriter may purchase and
sell securities in the open market. These transactions may include
short sales, stabilizing transactions and purchases to cover
positions created by short sales. Shorts sales involve the sale by
the underwriters of a greater number of securities than they are
required to purchase in the offering. “Covered” short sales are
sales made in an amount not greater than the underwriters’ option
to purchase additional securities from us, if any, in the offering.
If the underwriters have an over-allotment option to purchase
additional securities from us, the underwriters may close out any
covered short position by either exercising their over-allotment
option or purchasing securities in the open market. In determining
the source of securities to close out the covered short position,
the underwriters may consider, among other things, the price of
securities available for purchase in the open market as compared to
the price at which they may purchase securities through the
over-allotment option. “Naked” short sales are any sales in excess
of such option or where the underwriters do not have an
over-allotment option. The underwriters must close out any naked
short position by purchasing securities in the open market. A naked
short position is more likely to be created if the underwriters are
concerned that there may be downward pressure on the price of the
securities in the open market after pricing that could adversely
affect investors who purchase in the offering.
Accordingly, to cover these short sales positions or to otherwise
stabilize or maintain the price of the securities, the underwriters
may bid for or purchase securities in the open market and may
impose penalty bids. If penalty bids are imposed, selling
concessions allowed to syndicate members or other broker-dealers
participating in the offering are reclaimed if securities
previously distributed in the offering are repurchased, whether in
connection with stabilization transactions or otherwise. The effect
of these transactions may be to stabilize or maintain the market
price of the securities at a level above that which might otherwise
prevail in the open market. The impositions of a penalty bid may
also effect the price of the securities to the extent that it
discourages resale of the securities. The magnitude or effect of
any stabilization or other transactions is uncertain. These
transactions may be effected on the Nasdaq Capital Market or
otherwise and, if commenced, may be discontinued at any time.
EXPERTS
The consolidated financial statements as of and for the years ended
December 31, 2017 and 2016, incorporated in this prospectus by
reference from the Company’s Annual Report on Form 10-K filed on
March 8, 2018 for the year ended December 31, 2017, have
been audited by Brightman Almagor Zohar & Co., a member of
Deloitte Touche Tohmatsu Limited, an independent registered public
accounting firm, as stated in their report (which report expresses
an unqualified opinion on the financial statements and includes an
explanatory paragraph regarding the Company's ability to continue
as a going concern), which is incorporated herein by reference, and
has been so incorporated in reliance upon the report of such firm
given upon their authority as experts in accounting and
auditing.
LEGAL MATTERS
Validity of the securities offered by this prospectus will be
passed upon for us by BRL Law Group LLC, Boston,
Massachusetts. As of June 8, 2018, Thomas B. Rosedale,
the Managing Member of BRL Law Group LLC, beneficially and of
record owns 69,090 shares of our common stock.

BRAINSTORM CELL THERAPEUTICS
INC.
Up to $45,000,000
Common Stock
PROSPECTUS
SUPPLEMENT
SVB Leerink |
Raymond James
|
September 25, 2020
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
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