Management to host conference call at
4:30pm EST today
Athersys, Inc. (NASDAQ: ATHX) announced today its financial results
for the period ended September 30, 2018.
Highlights of the third quarter of 2018 and
recent events include:
- Completed enrollment of our Phase
1/2 study evaluating MultiStem® therapy in acute respiratory
distress syndrome (ARDS) patients;
- Commenced enrollment of patients in
the MASTERS-2 Phase 3 registration study for ischemic stroke;
- Continued to support Healios’
ongoing TREASURE study for ischemic stroke in Japan by providing
clinical product;
- Extended to December 6, 2018,
Healios’ option and negotiation period for further expansion of the
collaboration, including an exclusive option for a license to
develop and commercialize MultiStem therapy in China for certain
indications;
- Recognized revenues of $2.3 million
and net loss of $9.7 million, or $0.07 net loss per share, for the
quarter ended September 30, 2018; and
- Cash and cash equivalents were
$48.0 million at the end of the third quarter.
“We had another solid quarter in the third
quarter of 2018 as we advanced key initiatives, reflected by the
completion of enrollment in our exploratory clinical trial
evaluating administration of MultiStem to patients suffering from
ARDS and the initiation of enrollment in the Phase 3 MASTERS-2
study for treating ischemic stroke,” commented Dr. Gil Van
Bokkelen, Chairman & CEO at Athersys. “We are working
collaboratively with Healios in multiple areas, and we further
strengthened our core capabilities.
“In addition, we have maintained a solid balance
sheet as we continue to implement our strategic plan, working
toward the achievement of our key goals on behalf of our
shareholders and the patients we are committed to helping,”
concluded Dr. Van Bokkelen.
Third Quarter
Results
Revenues increased to $2.3 million for the three
months ended September 30, 2018 compared to $0.4 million for the
three months ended September 30, 2017. Our revenues are generally
derived from license fees, manufacturing-related activities for
Healios, royalty and related contract revenue from our
collaborations, and grant revenue.
Research and development expenses increased to
$9.5 million for the three months ended September 30, 2018 from
$5.4 million for the comparable period in 2017. The $4.1 million
increase is primarily associated with increased clinical
development costs of $3.0 million, increased personnel costs of
$0.6 million, increased license fees of $0.2 million and increased
internal research supplies and other of $0.3 million. The $3.0
million increase in our clinical costs during the period is
primarily a result of increased clinical product manufacturing
costs, covered in part by Healios, technology transfer services
associated with planned Japan manufacturing for Healios, process
development activities to support large-scale manufacturing, and
costs related to our MASTERS-2 clinical trial that began enrolling
patients in the third quarter of 2018.
General and administrative expenses increased to
$2.6 million for the three months ended September 30, 2018 from
$2.1 million in the comparable period in 2017. The $0.5 million
increase was due primarily to increases in professional fees,
consulting services, personnel costs and other administrative costs
compared to the same period last year.
Net loss for the third quarter was $9.7 million
in 2018 compared to a net loss of $7.2 million in 2017. The
difference of $2.5 million reflects the above variances, as well as
an increase of $0.2 million in other income.
In the nine months ended September 30, 2018, net
cash used in operating activities was $8.8 million compared to
$17.9 million in the nine months ended September 30, 2017.
The difference reflects in part $15.0 million in license fees paid
by Healios in connection with the collaboration expansion and an
increase in clinical development activity in 2018. Healios is
obligated to make two more license fee payments of $2.5 million
each in December 2018 and March 2019. At September 30, 2018, we had
$48.0 million in cash and cash equivalents, compared to $29.3
million at December 31, 2017.
Conference Call
William (B.J.) Lehmann, President and Chief
Operating Officer, and Laura Campbell, Senior Vice President of
Finance, will host a conference call today to review the results as
follows:
Date |
Tuesday, November 6th, 2018 |
Time |
4:30 p.m. (Eastern Time) |
Telephone access: U.S. and Canada |
800-273-1254 |
Telephone access: International |
973-638-3440 |
Access code |
7396506 |
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 20, 2018 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 7396506.
About Athersys
Athersys is an international biotechnology
company engaged in the development of therapeutic products 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 MultiStem cell therapy
toward commercialization. More information is available at
www.athersys.com. Follow Athersys on Twitter at
www.twitter.com/athersys.
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
therapeutics, including the uncertainty regarding market acceptance
of our product candidates and our ability to generate revenues.
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: our ability to raise capital to fund our operations; the
timing and nature of results from our MultiStem 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
of our product candidates; the possibility of delays, work
stoppages or interruptions in manufacturing by third parties to us,
such as due to material supply constraints, contaminations, or
regulatory issues, which could negatively impact our trials and the
trials of our collaborators; uncertainty regarding market
acceptance of our product candidates and our ability to generate
revenues, including MultiStem cell therapy for the treatment of
stroke, acute respiratory distress syndrome, acute myocardial
infarction and trauma, and the prevention of graft-versus-host
disease and other disease indications; changes in external market
factors; changes in our industry's overall performance; changes in
our business strategy; our ability to protect and defend our
intellectual property and related business operations, including
the successful prosecution of our patent applications and
enforcement of our patent rights, and operate our business in an
environment of rapid technology and intellectual property
development; our possible inability to realize commercially
valuable discoveries in our collaborations with pharmaceutical and
other biotechnology companies; our ability to work with Healios to
reach an agreement for an option in China; our ability to meet
milestones and earn royalties under our collaboration agreements,
including the success of our collaboration with Healios; our
collaborators’ ability to continue to fulfill their obligations
under the terms of our collaboration agreements and generate sales
related to our technologies; the success of our efforts to enter
into new strategic partnerships and advance our programs,
including, without limitation, in North America, Europe and Japan;
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.
Contacts:
William (B.J.)
Lehmann
President and Chief Operating
Officer
Tel: (216) 431-9900bjlehmann@athersys.com
Karen Hunady Corporate Communications &
Investor RelationsTel: (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, |
|
2018 |
2017 |
|
(Unaudited) |
(Note) |
Assets |
|
|
Cash and cash
equivalents |
$ |
47,967 |
$ |
29,316 |
Accounts
receivable |
|
573 |
|
586 |
Accounts
receivable – Healios, billed and unbilled |
|
7,252 |
|
153 |
Contractual right to consideration from Healios |
|
440 |
|
-- |
Other
asset related to Healios |
|
4,220 |
|
-- |
Prepaid
expenses and other |
|
2,183 |
|
1,135 |
Equipment, net |
|
3,002 |
|
2,206 |
Deposits
and other |
|
892 |
|
197 |
Total assets |
$ |
66,529 |
$ |
33,593 |
|
|
|
Liabilities and stockholders’ equity |
|
|
Accounts
payable and accrued expenses |
$ |
13,747 |
$ |
9,312 |
Deferred
revenue |
|
-- |
|
771 |
Advances
from Healios |
|
2,445 |
|
134 |
Total
stockholders’ equity |
|
50,337 |
|
23,376 |
Total liabilities and stockholders’ equity |
$ |
66,529 |
$ |
33,593 |
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(Unaudited) |
(In Thousands, Except Per Share Amounts) |
|
Three months endedSeptember
30, |
|
2018 |
|
2017 |
|
Revenues |
|
|
Contract revenue from
Healios |
$ |
1,906 |
|
$ |
-- |
|
Royalty
and other contract revenue |
|
312 |
|
|
179 |
|
Grant
revenue |
|
103 |
|
|
220 |
|
Total
revenues |
|
2,321 |
|
|
399 |
|
|
|
|
Costs and expenses |
|
|
Research
and development |
|
9,545 |
|
|
5,441 |
|
General
and administrative |
|
2,556 |
|
|
2,113 |
|
Depreciation |
|
196 |
|
|
177 |
|
Total
costs and expenses |
|
12,297 |
|
|
7,731 |
|
Loss from
operations |
|
(9,976 |
) |
|
(7,332 |
) |
Other
income, net |
|
236 |
|
|
89 |
|
Net loss and comprehensive loss |
$ |
(9,740 |
) |
$ |
(7,243 |
) |
Net loss
per share – basic and diluted |
$ |
(0.07 |
) |
$ |
(0.06 |
) |
Weighted
average shares outstanding – basic and diluted |
|
138,930 |
|
|
114,515 |
|
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