Athersys, Inc. (Nasdaq:ATHX) today announced its financial results
for the three months ended September 30, 2017.
Highlights of the third quarter of 2017 and
recent events include:
- Our partner in Japan, HEALIOS K.K. (Healios), resumed
enrollment in the TREASURE stroke clinical trial, following a
temporary suspension related to placebo product;
- Entered into agreement with Nikon CeLL innovation Co., Ltd.
(Nikon) to prepare for manufacturing of MultiStem® cell therapy for
future commercialization in Japan by Healios;
- Awarded Regenerative Medicine Advanced Therapy designation
(RMAT) from U.S. Food and Drug Administration (FDA) for MultiStem
ischemic stroke program under the landmark 21st Century Cures
Legislation, which is intended to expedite the development and
regulatory review process and lead to accelerated U.S.
approval;
- Received Final Scientific Advice positive opinion for stroke
program from European Medicines Device Agency (EMA), establishing
alignment between European and U.S. regulators about potential for
product approval following a successful MASTERS-2 study;
- Progressed discussions with multiple parties regarding
collaboration and business opportunities associated with stroke
program;
- Included in Deloitte’s Technology Fast 500™, a ranking of the
500 fastest growing technology, media, telecommunications, life
sciences and energy tech companies in North America;
- Recognized revenues of $0.4 million for quarter ended September
30, 2017 and net loss of $7.2 million, or $0.06 net loss per share;
and
- Maintained a stable balance sheet with cash and cash
equivalents of $28.2 million at the end of the third quarter.
“Over the past year, we have submitted extensive data and
information to the FDA, EMA and other regulators who have conducted
a rigorous review of the results from the MASTERS-1 trial and the
other information we have provided for their consideration,”
commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys.
“In response, we have received multiple important regulatory
designations, including the Fast Track designation from the FDA
earlier this year and, more recently, the RMAT designation, as well
as the positive opinion from EMA. These actions provide
tangible evidence of the support we have received from regulators
following their careful review of the clinical data and
information, and the potential this program has for redefining
clinical care for patients that have suffered a debilitating
ischemic stroke.
“We are pleased that Healios’ stroke study has
resumed, following the resupply of placebo. In addition to
our support for the ongoing TREASURE study and continued
preparations for the MASTERS-2 study, we are laying the groundwork
for commercialization in anticipation of clinical success. An
important recent step was the establishment of a collaboration with
Nikon to prepare for commercial manufacturing to support initial
commercialization of MultiStem therapy for stroke in Japan.
We are also engaged in related activities to support manufacturing
scale-up and commercial supply.”
Dr. Van Bokkelen continued, “We have also
advanced our discussions with potential business partners to
support development and commercialization activities, particularly
related to our lead stroke program, and we are currently engaged in
active negotiations, discussions and other activities regarding
specific proposals with certain companies. As we have
conveyed previously, we are intent on establishing one or more
partnerships that balance our partner’s contribution of
capabilities and resources, commitment to the program, and
appropriate recognition of the value of the commercial
opportunity. Though we are currently focused on several
possible options, we cannot provide guidance about the precise
nature, scope and size of any potential partnership while this
process is ongoing. Needless to say, this remains an
important priority and objective for the company and our
shareholders.”
Third Quarter
Results
Revenues increased to $0.4 million for the three
months ended September 30, 2017, compared to $0.3 million for the
three months ended September 30, 2016, due to an increase of $0.1
million in grant revenues. Our grant revenues fluctuate from period
to period based on the timing of grant-related activities and the
award and expiration of new grants. Research and development
expenses increased to $5.4 million for the three months ended
September 30, 2017 from $5.3 million in the comparable period in
2016. The $0.1 million increase is primarily comprised of an
increase in preclinical and clinical development costs of $0.8
million partially offset by decreases in internal research supplies
of $0.4 million, sponsored research costs of $0.2 million and
travel costs of $0.1 million.
General and administrative expenses increased to
$2.1 million for the three months ended September 30, 2017 from
$1.8 million in the comparable period in 2016. The $0.3
million increase was due primarily to increases in personnel costs
of $0.1 million, stock-based compensation of $0.1 million and other
administrative costs of $0.1 million.
Net loss was $7.2 million in the 2017 third
quarter, compared to net loss of $6.0 million in the comparable
period in 2016. The difference of $1.2 million reflects the
above variances, as well as a non-recurring $0.2 million gain on
the fair value of warrant liabilities and a non-recurring $0.7
million net gain from insurance proceeds related to flood damage,
both of which were recognized in the third quarter of 2016.
Cash used in operating activities was $6.8
million during the 2017 third quarter, compared to cash used of
$5.5 million in the 2016 third quarter. As of September 30, 2017,
we had $28.2 million in cash and cash equivalents, compared to
$14.8 million at December 31, 2016, which includes, among other
things, the impact of the common stock offering in February 2017,
the exercise of warrants to purchase common stock and proceeds from
the issuance of common stock under our equity purchase
facility.
Conference Call
Gil Van Bokkelen, Chairman and Chief Executive
Officer, and William (BJ) Lehmann, President and Chief Operating
Officer, will host a conference call today to review the results as
follows:
Date |
Wednesday, November 8, 2017 |
Time |
4:30 p.m. (Eastern Time) |
Telephone access: U.S. and Canada |
800-273-1254 |
Telephone access: International |
973-638-3440 |
Access code |
96178367 |
Live webcast |
www.athersys.com, under the Investors section |
A replay will be available for on-demand
listening shortly after the completion of the call until 11:59 PM
Eastern Time on November 22, 2017 at the aforementioned URL, or by
dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or
from abroad (404) 537-3406, and entering access code 96178367.
About Athersys
Athersys is an international biotechnology
company engaged in the discovery and development of therapeutic
product candidates designed to extend and enhance the quality of
human life. The Company is developing its MultiStem® cell therapy
product, a patented, adult-derived "off-the-shelf" stem cell
product, initially for disease indications in the neurological,
cardiovascular, and inflammatory and immune disease areas, and has
several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys has forged strategic
partnerships and a broad network of collaborations to further
advance the MultiStem cell therapy toward commercialization.
More information is available at www.athersys.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainties. These
forward-looking statements relate to, among other things, the
expected timetable for development of our product candidates, our
growth strategy, and our future financial performance, including
our operations, economic performance, financial condition,
prospects, and other future events. We have attempted to identify
forward-looking statements by using such words as "anticipates,"
"believes," "can," "continue," "could," "estimates," "expects,"
"intends," "may," "plans," "potential," "should," “suggest,”
"will," or other similar expressions. These forward-looking
statements are only predictions and are largely based on our
current expectations. A number of known and unknown risks,
uncertainties, and other factors could affect the accuracy of these
statements. Some of the more significant known risks that we face
that could cause actual results to differ materially from those
implied by forward-looking statements are the risks and
uncertainties inherent in the process of discovering, developing,
and commercializing products that are safe and effective for use as
human therapeutics, such as the uncertainty regarding regulatory
approval and market acceptance of our product candidates and our
ability to generate revenues, including MultiStem for the treatment
of ischemic stroke, acute myocardial infarction, spinal cord injury
and acute respiratory distress syndrome and other disease
indications, including graft-versus-host disease. These risks may
cause our actual results, levels of activity, performance, or
achievements to differ materially from any future results, levels
of activity, performance, or achievements expressed or implied by
these forward-looking statements. Other important factors to
consider in evaluating our forward-looking statements include: the
success of our collaboration with Healios and others, including our
ability to reach milestones and receive milestone payments, and
whether any products are successfully developed and sold so that we
earn royalty payments; our possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; our
collaborators' ability to continue to fulfill their obligations
under the terms of our collaboration agreements; the success of our
efforts to enter into new strategic partnerships or collaborations
and advance our programs; our ability to raise additional capital;
results from our MultiStem ongoing and planned clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios
TREASURE clinical trial in Japan; the possibility of delays in,
adverse results of, and excessive costs of the development process;
our ability to successfully initiate and complete clinical trials
within the expected time frame or at all; changes in external
market factors; changes in our industry's overall performance;
changes in our business strategy; our ability to protect our
intellectual property portfolio; our possible inability to execute
our strategy due to changes in our industry or the economy
generally; changes in productivity and reliability of suppliers;
and the success of our competitors and the emergence of new
competitors. You should not place undue reliance on forward-looking
statements contained in this press release, and we undertake no
obligation to publicly update forward-looking statements, whether
as a result of new information, future events or otherwise.
ATHX-G
Contact:
William (B.J.) Lehmann,
J.D.
President and Chief Operating
Officer
Tel: (216)
431-9900bjlehmann@athersys.com
Karen Hunady Corporate CommunicationsTel: (216)
431-9900khunady@athersys.com
David Schull Russo Partners, LLCTel: (212)
845-4271 or (858)
717-2310David.schull@russopartnersllc.com
|
(Tables Follow) |
|
Athersys, Inc. |
Condensed Consolidated Balance
Sheets |
(In thousands) |
|
|
|
|
September 30, |
December 31, |
|
2017 |
2016 |
|
(Unaudited) |
(Note) |
Assets |
|
|
Cash and cash
equivalents |
$ |
28,234 |
$ |
14,753 |
Other current
assets |
|
1,738 |
|
1,527 |
Equipment, net |
|
2,265 |
|
2,605 |
Deferred tax
assets |
|
198 |
|
175 |
Total
assets |
$ |
32,435 |
$ |
19,060 |
|
|
|
Liabilities and
stockholders’ equity |
|
|
Accounts payable and
accrued expenses |
$ |
5,860 |
$ |
6,875 |
Deferred revenue |
|
503 |
|
-- |
Warrant
liabilities |
|
-- |
|
1,004 |
Total stockholders’
equity |
|
26,072 |
|
11,181 |
Total
liabilities and stockholders’ equity
|
$ |
32,435 |
$ |
19,060 |
Note: The Condensed
Consolidated Balance Sheet Data has been derived from the audited
financial statements as of that date. |
Athersys, Inc. |
Condensed Consolidated Statements of Operations
and Comprehensive Loss |
(In Thousands, Except Per Share Amounts) |
|
Three months
endedSeptember 30, |
|
2017 |
|
2016 |
|
Revenues |
|
|
Contract revenue |
$ |
179 |
|
$ |
150 |
|
Grant revenue |
|
220 |
|
|
161 |
|
Total revenues |
|
399 |
|
|
311 |
|
|
|
|
Costs and
expenses |
|
|
Research and
development |
|
5,441 |
|
|
5,263 |
|
General and
administrative |
|
2,113 |
|
|
1,830 |
|
Depreciation |
|
177 |
|
|
114 |
|
Total costs and expenses |
|
7,731 |
|
|
7,207 |
|
Gain from insurance
proceeds, net |
|
-- |
|
|
682 |
|
Loss from
operations |
|
(7,332 |
) |
|
(6,214 |
) |
Income from change in
fair value of warrants |
|
-- |
|
|
191 |
|
Other income, net |
|
71 |
|
|
7 |
|
Loss before
income taxes |
|
(7,261 |
) |
|
(6,016 |
) |
Income tax
benefit |
|
18 |
|
|
12 |
|
Net loss and
comprehensive loss |
$ |
(7,243 |
) |
$ |
(6,004 |
) |
Net loss per share –
Basic and Diluted |
$ |
(0.06 |
) |
$ |
(0.07 |
) |
Weighted average shares
outstanding – Basic
|
|
114,515,405 |
|
|
84,928,198 |
|
Weighted average shares
outstanding – Diluted
|
|
114,515,405 |
|
|
85,896,993 |
|
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