Athersys, Inc. (NASDAQ: ATHX) announced today its financial results
for the three months ended June 30, 2019.
Highlights of the second quarter of 2019 and recent events
include:
- Received Fast Track designation from the FDA for our clinical
development program involving administration of MultiStem® cell
therapy for treatment of acute respiratory distress syndrome
(“ARDS”);
- Presented positive results from the MUST-ARDS study at the
American Thoracic Society International Conference in May
2019;
- Announced first patient enrolled in the ONE-BRIDGE study in
Japan being conducted by our partner in Japan, HEALIOS K.K.
(“Healios”), evaluating MultiStem cell therapy treatment of
patients suffering from pneumonia-induced ARDS;
- Advanced our ischemic stroke program, both through support of
Healios' TREASURE study in Japan and increased enrollment in our
MASTERS-2 Phase 3 registrational study;
- Entered into an open market sales agreement with Jefferies LLC,
i.e., an 'at-the-market' equity program, providing additional
flexibility and capital markets access as we progress to important
milestones;
- Hosted a successful investor day in New York City in May 2019
highlighting our capabilities and technologies, as well as progress
made developing the MultiStem product platform;
- Increased our media exposure as we were featured in video,
podcasts and articles in the major publications Fortune and
Forbes;
- Participated in several events at the International Society of
Cell and Gene Therapy Conference in June 2019, including podium
presentations, a panel participation and chairing a session,
further establishing the Company as a leader and significant
contributor in the field of cell therapy;
- Recognized revenues of $4.3 million and net loss of
$9.7 million, or $0.06 net loss per share, for the quarter
ended June 30, 2019; and
- Ended the 2019 second quarter with $44.2 million of cash
and cash equivalents.
“We continue to make steady progress in key areas, including
advancing our Phase 3 clinical program for treating ischemic
stroke, while supporting Healios in the advancement of its TREASURE
study for stroke patients and ONE-BRIDGE study for ARDS patients in
Japan,” commented Dr. Gil Van Bokkelen, Chairman &
CEO at Athersys. “Given our progress in multiple areas, including
the recently announced Fast Track designation and promising results
from our ARDS clinical program, we are exploring partnering
opportunities in several important geographic areas, while we
continue to advance our key initiatives and expand core
capabilities. This includes continuing to advance our manufacturing
activities and initiatives, that we believe will represent a
significant competitive advantage as we move into
commercialization.
“While we advance our programs through clinical development and
toward commercialization, we have also taken prudent and
appropriate steps to maintain a solid balance sheet, ensuring we
have access to additional capital while we continue to maintain a
long-term focus on creating value for our shareholders,” concluded
Dr. Van Bokkelen.
Second Quarter Results
Revenues were $4.3 million for the three months ended
June 30, 2019 compared to $19.4 million for the three
months ended June 30, 2018. Revenues from our collaboration
with Healios were $4.2 million in the second quarter of 2019
compared to $18.8 million for the same period last year, which
included the impact of the June 2018 collaboration expansion.
Royalty revenue from RTI Surgical, Inc. ceased late in 2018 upon
its decision to discontinue distribution of the licensed product.
Our revenues are generally derived from license fees,
manufacturing-related activities for Healios, other contract
revenue from our collaborations and grant revenue.
Research and development expenses increased to
$11.1 million for the three months ended June 30, 2019
from $10.1 million for the comparable period in 2018. The
$1.0 million net increase is associated with increases in
clinical trial and manufacturing process development costs of
$0.7 million, personnel costs of $0.4 million, internal
research supplies of $0.3 million and stock compensation costs
of $0.2 million, with such increases partially offset by a decrease
in license fees of $0.6 million. Included in our clinical expenses
are costs associated with providing manufacturing services to
Healios, which are invoiced to Healios in accordance with our
collaboration agreements.
General and administrative expenses increased to
$2.9 million for the three months ended June 30, 2019
from $2.4 million in the comparable period in 2018. The
$0.5 million increase was due primarily to increased personnel
costs, legal and professional fees, travel costs and stock
compensation costs compared to the same period last year.
Net loss for the second quarter of 2019 was $9.7 million
compared to net income of $6.9 million in the second quarter
of 2018. The variance of $16.6 million is primarily
attributable to the June 2018 expansion of the Healios
collaboration.
In the six months ended June 30, 2019, net cash used in
operating activities was $17.0 million compared to
$1.3 million in the six months ended June 30, 2018, with
2018 being impacted by proceeds from the Healios collaboration
expansion. At June 30, 2019, we had $44.2 million in cash
and cash equivalents, compared to $51.1 million at
December 31, 2018.
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 |
|
August 7, 2019 |
Time |
|
4:30 p.m. (Eastern Time) |
Telephone access: U.S. and Canada |
|
(877) 396-3286 |
Telephone access: International |
|
(647) 689-5528 |
Access code |
|
5087881 |
Live webcast |
|
www.athersys.com, under the Investors section |
We encourage shareholders to listen using the webcast link and
to use the phone line if you intend to ask a question. A replay
will be available at www.athersys.com under the Investors
section approximately two hours after the call has ended.
Shareholders may also call in for on-demand listening shortly after
the completion of the call until 11:59 PM Eastern Time on August
14, 2019 by dialing (800) 585-8367 or (416) 621-4642 and
entering Encore passcode 5087881.
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, inflammatory
and immune, cardiovascular, and other critical care indications 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. 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 Healios’ TREASURE and ONE-BRIDGE
clinical trials 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 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, J.D.President and Chief Operating
OfficerTel: (216) 431-9900bjlehmann@athersys.com
Karen HunadyCorporate Communications & Investor
RelationsTel: (216) 431-9900khunady@athersys.com
David SchullRusso Partners, LLCTel: (212) 845-4271 or (858)
717-2310David.schull@russopartnersllc.com
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|
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Athersys, Inc. |
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
|
|
(Unaudited) |
|
(Note) |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
44,237 |
|
|
$ |
51,059 |
|
Accounts receivable |
|
80 |
|
|
262 |
|
Accounts receivable from
Healios, billed and unbilled |
|
2,908 |
|
|
4,728 |
|
Prepaid expenses, deposits and
other |
|
2,960 |
|
|
2,679 |
|
Equipment, net |
|
3,062 |
|
|
3,002 |
|
Total
assets |
|
$ |
53,247 |
|
|
$ |
61,730 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Accounts payable, accrued
expenses and other |
|
$ |
14,952 |
|
|
$ |
12,801 |
|
Deferred revenue and deposits
from Healios |
|
2 |
|
|
2,674 |
|
Advance from Healios |
|
5,042 |
|
|
3,139 |
|
Total stockholders'
equity |
|
33,251 |
|
|
43,116 |
|
Total liabilities and
stockholders’ equity |
|
$ |
53,247 |
|
|
$ |
61,730 |
|
|
|
|
|
|
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) Income |
(Unaudited) |
(In Thousands, Except Per Share Amounts) |
|
|
|
|
|
Three months ended June 30, |
|
|
2019 |
|
2018 |
Revenues |
|
|
|
|
Contract revenue from Healios |
|
$ |
4,193 |
|
|
$ |
18,755 |
|
Royalty and other contract
revenue |
|
— |
|
|
591 |
|
Grant revenue |
|
69 |
|
|
45 |
|
Total revenues |
|
4,262 |
|
|
19,391 |
|
Costs and
expenses |
|
|
|
|
Research and development |
|
11,139 |
|
|
10,093 |
|
General and
administrative |
|
2,867 |
|
|
2,382 |
|
Depreciation |
|
157 |
|
|
191 |
|
Total costs and expenses |
|
14,163 |
|
|
12,666 |
|
Gain from insurance
proceeds |
|
— |
|
|
20 |
|
(Loss) income from
operations |
|
(9,901 |
) |
|
6,745 |
|
Other income, net |
|
213 |
|
|
188 |
|
Net (loss) income and
comprehensive (loss) income |
|
$ |
(9,688 |
) |
|
$ |
6,933 |
|
Net (loss) income per share,
basic |
|
$ |
(0.06 |
) |
|
$ |
0.05 |
|
Weighted average shares
outstanding, basic |
|
150,163 |
|
|
138,225 |
|
Net (loss) income per share -
diluted |
|
$ |
(0.06 |
) |
|
$ |
0.05 |
|
Weighted average shares
outstanding - diluted |
|
150,163 |
|
|
139,375 |
|
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