Athersys, Inc. (NASDAQ: ATHX) announced today its financial results
for the three months ended March 31, 2019.
Highlights of the first quarter of 2019 and recent events
include:
- Announced positive results from our exploratory clinical study
of MultiStem® cell therapy for treatment of acute respiratory
distress syndrome ("MUST-ARDS"), showing reduced mortality and
greater ventilator-free and ICU-free days in patients with moderate
to severe ARDS;
- The MUST-ARDS study has been selected for presentation at the
American Thoracic Society International Conference on May 20,
2019;
- Our partner in Japan, HEALIOS K.K. ("Healios"), announced its
first patient enrolled in the ONE-BRIDGE study in Japan, evaluating
MultiStem cell therapy treatment of patients who suffer from
pneumonia-induced ARDS;
- Advanced ischemic stroke program, supporting Healios' TREASURE
study and ramping up our MASTERS-2 Phase 3 registrational
study;
- Announced plans to host an investor day in New York City on May
14, 2019 that will highlight the Company's capabilities and
technologies, as well as progress made developing the MultiStem
product platform and future plans;
- Participated in several investor conferences and media
interviews, including "The Stem Cell Podcast" and the "Forbes Book
Podcast" as the featured guest; also featured live on TD
Ameritrade's "The WatchList";
- Launched a revamped website with a simplified design, improved
functionality and enhanced content to help educate our
visitors;
- Recognized revenues of $1.4 million for the quarter ended
March 31, 2019 and net loss of $13.0 million, or $0.09
net loss per share, for the quarter ended March 31, 2019;
and
- Ended the 2019 first quarter with $51.0 million of cash
and cash equivalents.
“We made continued progress in the first quarter of 2019 in
advancing our key initiatives, reflected by the release of results
from our ARDS study and the continued progress of enrollment in our
Phase 3 MASTERS-2 trial and the TREASURE registrational study being
conducted by our partner in Japan for treating ischemic stroke,”
commented Dr. Gil Van Bokkelen, Chairman & CEO at
Athersys. “We are working collaboratively with Healios in multiple
areas, which includes supporting their initiation of the ONE-BRIDGE
study for ARDS, 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.
First Quarter Results
Revenues increased to $1.4 million for the three months
ended March 31, 2019 compared to $1.1 million for the
three months ended March 31, 2018. Our revenues are generally
derived from license fees, manufacturing-related activities for
Healios, other royalty and related contract revenue from our
collaborations, and grant revenue. Revenues from our collaboration
with Healios increased quarter-over-quarter related to our
manufacturing services. Royalty revenues from RTI Surgical, Inc.
have concluded with its discontinuation of distribution of the
licensed product.
Research and development expenses increased to
$11.4 million for the three months ended March 31, 2019
from $8.9 million for the comparable period in 2018. The
$2.5 million increase is primarily associated with increased
clinical trial and manufacturing process development costs of
$1.9 million, increased personnel costs of $0.4 million,
and increased stock compensation costs of $0.1 million.
Included in our clinical costs are costs associated with providing
manufacturing services to Healios, which are invoiced to Healios in
accordance with the collaboration agreements.
General and administrative expenses increased to
$3.1 million for the three months ended March 31, 2019
from $2.7 million in the comparable period in 2018. The
$0.4 million increase was due primarily to increased legal and
professional fees, consulting services, and stock compensation
costs compared to the same period last year.
Net loss for the first quarter was $13.0 million in 2019
compared to a net loss of $10.2 million in 2018. The
difference of $2.8 million reflects the above variances, as
well as a decrease of $0.2 million in other income.
In the three months ended March 31, 2019, net cash used in
operating activities was $5.5 million compared to
$5.7 million in the three months ended March 31, 2018. At
March 31, 2019, we had $51.0 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 |
|
May 8, 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 |
|
6595362 |
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 May 15,
2019 by dialing (800) 585-8367 or (416) 621-4642 and entering
Encore passcode 6595362.
About AthersysAthersys 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 StatementsThis 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
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, 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
(Tables Follow)
|
Athersys, Inc. |
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
March 31, 2019 |
|
December 31, 2018 |
|
(Unaudited) |
|
(Note) |
Assets |
|
|
|
Cash and cash equivalents |
$ |
51,018 |
|
|
$ |
51,059 |
|
Accounts receivable |
11 |
|
|
262 |
|
Accounts receivable from
Healios, billed and unbilled |
2,467 |
|
|
4,728 |
|
Prepaid expenses, deposits and
other |
2,537 |
|
|
2,679 |
|
Equipment, net |
2,882 |
|
|
3,002 |
|
Total
assets |
$ |
58,915 |
|
|
$ |
61,730 |
|
Liabilities and
stockholders’ equity |
|
|
|
Accounts payable, accrued
expenses and other |
$ |
14,970 |
|
|
$ |
12,801 |
|
Deposit from Healios |
2,000 |
|
|
2,000 |
|
Deferred revenue |
1,173 |
|
|
674 |
|
Advance from Healios |
3,984 |
|
|
3,139 |
|
Total stockholders’
equity |
36,788 |
|
|
43,116 |
|
Total liabilities and
stockholders’ equity |
$ |
58,915 |
|
|
$ |
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 |
(Unaudited) |
(In Thousands, Except Per Share Amounts) |
|
|
Three months ended March 31, |
|
2019 |
|
2018 |
Revenues |
|
|
|
Contract revenue from Healios |
$ |
1,441 |
|
|
$ |
348 |
|
Royalty revenue |
— |
|
|
401 |
|
Grant revenue |
4 |
|
|
317 |
|
Total revenues |
1,445 |
|
|
1,066 |
|
Costs and
expenses |
|
|
|
Research and development |
11,415 |
|
|
8,850 |
|
General and
administrative |
3,106 |
|
|
2,655 |
|
Depreciation |
184 |
|
|
186 |
|
Total costs and expenses |
14,705 |
|
|
11,691 |
|
Gain from insurance
proceeds |
— |
|
|
363 |
|
Loss from operations |
(13,260 |
) |
|
(10,262 |
) |
Other income, net |
304 |
|
|
107 |
|
Net loss and
comprehensive loss |
$ |
(12,956 |
) |
|
$ |
(10,155 |
) |
Net loss per share, basic and
diluted |
$ |
(0.09 |
) |
|
$ |
(0.08 |
) |
Weighted average shares
outstanding, basic and diluted |
145,964 |
|
|
126,897 |
|
|
|
|
|
|
|
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