Athersys Reports Second Quarter 2013 Results

Athersys Reports Second Quarter 2013 Results

Management to Host Conference Call at 4:30 pm EDT Today

CLEVELAND, Aug. 13, 2013 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX)
today announced its financial results for the three months ended June 30,

"We are currently evaluating MultiStem^® in two Phase II clinical trials, in
ulcerative colitis and ischemic stroke, and are now moving a third program
into Phase II development," said Gil Van Bokkelen, Ph.D., Chairman and Chief
Executive Officer. "With the recently-awarded SBIR Fast Track grant, we plan
to initiate early next year a Phase II trial administrating MultiStem to
patients who have suffered an acute myocardial infarction (AMI), building on
the promising results demonstrated in our AMI Phase I trial."

Highlights of the second quarter of 2013 and recent events include:

  *Awarded an SBIR Fast Track grant of up to $2.8 million to support Phase II
    clinical trial of MultiStem program for heart attack patients; 
  *Advanced with partner, Pfizer, Phase II clinical study of MultiStem
    administration to patients suffering from ulcerative colitis. Initial
    results from this double blind, placebo-controlled trial are now expected
    in early 2014;
  *Ended the quarter with $18.9 million in cash and cash equivalents,
    compared to $21.3 million for the quarter ended March 31, 2013;
  *RTI Surgical announced the first human implant of map3™ cellular
    allogeneic bone graft, which incorporates MAPC™ technology licensed from
    Athersys; and
  *Published in STEM CELLS Translational Medicine preclinical study results
    demonstrating that Multipotent Adult Progenitor Cells increase the
    long-term survival of organ transplants and appear to alleviate the need
    for long-term immune suppression.

"We are encouraged by the progress in developing MultiStem, our lead platform
and proprietary allogeneic stem cell product, and are pleased to have
increasing clarity with respect to the remaining timeline for the Phase II
ulcerative colitis trial being conducted by Pfizer," added Dr. Van Bokkelen.

"Pfizer has worked closely with Athersys to design and execute the MultiStem
clinical study over the last three years," commented Dr. Ruth McKernan, Chief
Scientific Officer at Neusentis, a Pfizer Research Unit. "We believe this to
be a rigorous, statistically-robust clinical trial, which will provide
important insight into MultiStem's potential for patients with ulcerative
colitis. Due to some challenges with recruitment associated with the volume of
clinical studies in this area, we now look forward to results in early 2014."

"All of these activities underscore our mission to develop and establish
partnerships around therapeutic product candidates that address significant
unmet medical needs in multiple disease areas with an expanding portfolio of
therapeutic product development programs. These programs represent both major
areas of clinical need and substantial commercial opportunities," concluded
Dr. Van Bokkelen.

Second Quarter

For the three months ended June 30, 2013, total revenues were $0.6 million
compared to $2.7 million in the same period in 2012, reflecting a decrease in
contract revenues from our Pfizer collaboration due to the end of the revenue
recognition period in June 2012. Grant revenue remained relatively consistent
for the periods presented.

Research and development expenses were $5.1 million in the second quarter of
2013 compared to $5.0 million in the prior year period.Higher patent legal
fees and personnel costs were partially offset by a decrease in clinical and
preclinical development and sponsored research costs. General and
administrative expenses increased to $1.6 million in the second quarter of
2013 compared to $1.2 million in the prior year period due to increases in
advisory and other external service provider costs, legal and professional
fees, and personnel costs. 

Income of $216,000 was recognized during the quarter ended June 30, 2013 from
the change in the market value of warrant liabilities, compared to expense of
$96,000 during the prior year period. Net loss for the three months ended
June 30, 2013 was $5.9 million compared to a net loss of $3.7 million for the
three months ended June 30, 2012, with the difference largely attributable to
the decrease in Pfizer contract revenues.

As of June 30, 2013, the company had cash and cash equivalents of $18.9
million, compared to $25.5 million at December 31, 2012.Over the six-month
period, cash used for operations and capital investment was offset by $5.8
million in proceeds from equity sales pursuant to the company's equity
purchase agreement.

Conference Call

As previously announced, Gil Van Bokkelen, Chairman and Chief Executive
Officer, and William (B.J.) Lehmann, President and Chief Operating Officer,
will host a conference call today to review the results as follows:

  Date             August 13, 2013
  Time             4:30 p.m. (Eastern Time)
  Telephone access 800-273-1254 (U.S. and Canada)
                  973-638-3440 (International)
  Access code      21897115
  Live webcast, under the Investors section

A replay will be available for on-demand listening shortly after the
completion of the call until 11:59 p.m. (Eastern Time) on August 27, 2013 by
dialing 800-585-8367 or 855-859-2056 (U.S. and Canada), or 404-537-3406, and
entering access code 21897115. The archived webcast will be available for one
year at the aforementioned URL.

About Athersys

Athersys is a clinical stage 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 platform for disease indications in the cardiovascular, neurological,
inflammatory and immune disease areas. The Company currently has several
clinical stage programs involving MultiStem, including for treating
inflammatory bowel disease, ischemic stroke, damage caused by myocardial
infarction, and for the prevention of graft-versus-host disease. Athersys has
also developed a diverse portfolio that includes other technologies and
product development opportunities, and has forged strategic partnerships and
collaborations with leading pharmaceutical and biotechnology companies, as
well as world-renowned research institutions in the United States and Europe
to further develop its platform and products. More information is available at

The Athersys, Inc. logo is available at:

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
market acceptance of our product candidates and our ability to generate
revenues, including MultiStem for the treatment of inflammatory bowel disease,
acute myocardial infarction, stroke and other disease indications, including
lysosomal storage disorders, and the prevention of 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: our ability to raise additional capital;
final results from our MultiStem clinical trials; the possibility of delays
in, adverse results of, and excessive costs of the development process; our
ability to successfully initiate and complete clinical trials; 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 realize commercially valuable
discoveries in our collaborations with pharmaceutical and other biotechnology
companies; our ability to meet milestones under our collaboration agreements;
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 and advance our programs; 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. 

Athersys, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
                                      June 30,           December 31,
                                       2013               2012
                                      (Unaudited)        (Note)
Cash and cash equivalents              $18,897            $ 25,533
Other current assets                   904                776
Equipment, net                         1,396              1,294
Total assets                           $21,197            $ 27,603
Liabilities and stockholders' equity                    
Accounts payable and accrued expenses  $ 4,556            $ 4,478
Warrant liabilities and note payable   4,876              2,878
Total stockholders' equity            11,765             20,247
Total liabilities and stockholders'    $ 21,197           $ 27,603
Note:The Condensed Consolidated Balance Sheet Data at December 31, 2012 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 share and per share amounts)
                                 Three months ended    Six months ended
                                  June 30,              June 30,
                                 2013       2012       2013        2012
Contract revenue                  $ 194      $ 2,270    $ 278       $ 4,733
Grant revenue                     377        387        619         671
Total revenues                    571        2,657      897         5,404
Costs and expenses                                               
Research and development         5,107      5,027      10,683      10,596
General and administrative        1,555      1,162      3,062       2,421
Depreciation                      86         80         171         155
Total costs and expenses          6,748      6,269      13,916      13,172
Loss from operations              (6,177)    (3,612)    (13,019)    (7,768)
Other income (expense), net       15         (5)        32          (760)
Income (expense) from change in   216        (96)       (2,347)     479
fair value of warrants
Net loss                          $(5,946) $(3,713) $(15,334) $(8,049)
Basic and diluted net loss per    $(0.11)  $(0.13)  $(0.28)   $(0.29)
Weighted average shares           56,028,461 29,405,986 54,744,254  27,476,603
outstanding, basic and diluted
Other comprehensive loss:                                        
Other comprehensive (loss) income --        --        --         (28)
Comprehensive loss                $(5,946) $(3,713) $(15,334)  $(8,077)

CONTACT: William (B.J.) Lehmann, J.D.
         President and Chief Operating Officer
         Tel: (216) 431-9900
         Investor Relations:
         Lisa M. Wilson
         In-Site Communications
         Tel: (917) 543-9932

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