Clinical trial results in Acute Respiratory
Distress Syndrome (ARDS) supported Fast Track designation by FDA
and designation by the Biomedical Advanced Research and Development
Authority (BARDA) as a "Highly Relevant" program for
COVID-19 and other pathogens
Management to host conference call at 4:30
PM EST today
Athersys, Inc. (NASDAQ: ATHX) announced today its fourth quarter
2019 and annual 2019 financial results and recent highlights.
“Throughout all of 2019, we made important progress in our key
clinical programs in stroke and in other areas, as evidenced by the
highly promising clinical results from our ARDS program. Those
results led to the subsequent Fast Track designation from the FDA,”
commented Dr. Gil Van Bokkelen, Chairman and Chief Executive
Officer of Athersys. “The importance of this program has been
reinforced by the recent COVID-19 outbreak, where many patients
have subsequently become critically ill with ARDS, which a recent
World Health Organization analysis has confirmed is the primary
cause of death for these patients. This often fatal syndrome can be
induced by a range of pathogens, including COVID-19, SARS, MERS and
virulent influenza.
“Other than placing patients on a ventilator, there is no
effective treatment for ARDS. In January, in the early stages of
the COVID-19 outbreak, as part of the U.S. Government's COVID-19
CoronaWatch program, we were approached by BARDA in its leadership
role focused on expediting diagnostics, vaccines, antivirals and
therapeutic treatments for these patients. After undergoing
multiple reviews, we are pleased to announce that MultiStem® was
designated as a “Highly Relevant” therapeutic for COVID-19 by
BARDA. We now are working to expedite the further advancement of
the program, which has also shown relevance to certain other areas
of interest for BARDA,” added Dr. Van Bokkelen.
Fourth Quarter 2019 and Recent Highlights:
- Completed our exploratory clinical study of MultiStem cell
therapy for ARDS and announced positive 28-day and one-year
results; MultiStem treated patients reported consistent improvement
in quality of life over the one-year evaluation period and showed
marked improvements in key clinical metrics, including ICU-free
days, ventilator-free days and reduced mortality compared to
placebo, especially in patients with pneumonia-induced ARDS;
- Advanced through Japanese partner, HEALIOS K.K. (Healios), its
ARDS and ischemic stroke programs, with Healios expecting to finish
enrollment of both its ONE-BRIDGE ARDS study and the TREASURE
stroke study this year;
- Athersys' ARDS program received Fast Track designation from the
U.S. Food and Drug Association (FDA);
- Healios ARDS program, using HLCM051 (as MultiStem cell therapy
is designated in Japan), received orphan regenerative medicine
designation from Japan's Ministry of Health, Labour and
Welfare;
- Appointed Mr. Ivor Macleod as our Chief Financial Officer to
help plan and execute our financial strategy as we approach
potential product commercialization and beyond;
- Launched new clinical sites for our MASTERS-2 Phase 3
registration study for ischemic stroke from which we are observing
good enrollment rates;
- Actively engaged in partnering discussions with companies
interested in MultiStem commercialization in Europe and other
regions;
- Recognized revenues of $0.3 million and net loss of $9.9
million, or $0.06 net loss per share, for the quarter ended
December 31, 2019; and
- Ended 2019 with $35.0 million in cash and cash
equivalents.
Other 2019 and Recent Highlights:
- Advanced preparations for planned Phase 2 trauma clinical study
and a Phase 3 ARDS clinical study, following the success of our
ARDS exploratory trial;
- 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;
- Participated in several events throughout the year, including
the American Thoracic Society International Conference in May 2019
and the International Society of Cell and Gene Therapy Conference
in June 2019, among others, which included podium presentations and
panel participation, further establishing the Company as a leader
and significant contributor in the field of cell therapy;
- Expanded our process development and manufacturing efforts,
added diversification in our manufacturing networks and delivered
all the investigational clinical product to Healios to finish the
ONE-BRIDGE and TREASURE studies;
- Added to our talent pool increasing our employee base by 17% in
2019; and
- Entered into a new equity facility during the fourth quarter of
2019 as a follow-on to the existing facility, giving us the ability
to sell up to $100 million of our common stock over a three-year
period, providing access to capital to support operations.
“We remain highly focused on achieving our core goals and are
making excellent progress. Our near-term priorities are to finalize
and implement an alliance with BARDA, establish a high value
collaboration around our critical care programs, and continue to
advance our clinical programs, while we add additional talent and
leadership to the organization and expand our capabilities,”
concluded Dr. Van Bokkelen.
Fourth Quarter 2019 Financial Results
Revenues decreased to $0.3 million for the three months ended
December 31, 2019 compared to $1.5 million for the three months
ended December 31, 2018. Our collaboration revenues are primarily
derived from our Healios arrangement and declined in the fourth
quarter of 2019 as certain services, such as clinical product
supply, were concluded. We expect our collaboration revenues to
vary over time as we contract with Healios to perform manufacturing
services and as we potentially enter into new collaborations.
Research and development expenses decreased to $7.6 million for
the three months ended December 31, 2019 from $10.2 million for the
comparable period in 2018. The $2.6 million decrease is primarily
associated with the conclusion of the manufacturing campaign for
Healios' clinical trials and the reduction in technology transfer
activities associated with planned Japan manufacturing for Healios,
as well as the timing of reagent purchases used for our internal
process development activities.
General and administrative expenses decreased to $2.4 million
for the three months ended December 31, 2019 from $2.8 million in
the comparable period in 2018. The $0.4 million decrease in the
fourth quarter of 2019 was due primarily to lower professional
service fees and lower personnel costs associated with no bonus
accrual for the Company's leadership.
Net loss for the fourth quarter was $9.9 million in 2019
compared to a net loss of $11.3 million in the fourth quarter of
2018. The difference of $1.4 million reflects the above variances,
as well as a decrease of $0.4 million in other income items.
Full Year 2019 Financial Results
Revenues decreased to $5.6 million for the year ended December
31, 2019 from $24.3 million in 2018. Our contract revenues from our
collaboration with Healios decreased $16.8 million year over year,
reflecting the expansion of our collaboration in June 2018 to
include additional licensed indications, and the decline in certain
Healios-funded services in 2019. Included in our 2018 revenues were
royalties and other contract revenues of $1.5 million primarily
related to our collaboration with RTI Surgical, Inc., which has
since ceased distribution of its bone graft product that utilized
our technology.
Research and development expenses increased to $39.0 million for
the year ended December 31, 2019 from $38.7 million for the year
ended December 31, 2018. The increase in research and development
expenses year-over-year of $0.3 million related primarily to
increases in personnel costs of $1.5 million, including stock-based
compensation, consulting costs of $0.6 million, and other costs of
$0.1 million. These increases were partially offset by decreases in
clinical trial and manufacturing process development costs of $1.1
million and license fees of $0.8 million. We expect our research
and development expenses to increase in 2020 primarily related to
our clinical development and manufacturing process development
activities.
General and administrative expenses increased to $11.4 million
in 2019 from $10.4 million in 2018. The $1.0 million increase was
due primarily to increases in legal and professional services,
other outside services and stock compensation expense. We expect
our general and administrative expenses to increase in 2020
primarily related to personnel costs.
Net loss was $44.6 million in 2019 compared to a net loss of
$24.3 million in 2018. The difference of $20.3 million reflects the
above variances, as well as an increase of $0.3 million in other
net expenses.
In the twelve months ended December 31, 2019, net cash used in
operating activities was $35.3 million compared to $13.4 million in
the twelve months ended December 31, 2018. The difference is
primarily associated with license fees paid by Healios in 2018 in
connection with the collaboration expansion, combined with overall
increases in cash usage to fund our clinical development activity
in 2019.
At December 31, 2019, we had $35.0 million in cash and cash
equivalents, compared to $51.1 million at December 31, 2018.
Conference Call
Members of the management team will host a conference call today
to review the results as follows:
Date
March 16, 2020
Time
4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada
(877) 396-3286
Telephone access: International
(647) 689-5528
Encore Password (needed for the replay
only)
9937937
Live webcast
Webcast link
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 on the webcast link at www.athersys.com under the investors section
approximately three 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 March 21,
2020 by dialing (800) 585-8367 or (416) 621-4642 and entering the
conference code 9937937.
The archived webcast will be available for one year at the
aforementioned URL.
About Athersys
Athersys is a 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
successfully finalize and implement an alliance with BARDA and the
terms of any such alliance, 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.
(Tables Follow)
Athersys, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
December 31,
2019
2018
Assets
Cash and cash equivalents
$
35,041
$
51,059
Accounts receivable
17
262
Accounts receivable from Healios, billed
and unbilled
945
4,728
Prepaid expenses, deposits and other
2,781
2,679
Equipment, net
2,882
3,002
Total assets
$
41,666
$
61,730
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other
$
11,924
$
12,801
Accounts payable to Healios
1,068
—
Deposit from Healios
—
2,000
Deferred revenue
65
674
Advance from Healios
5,338
3,139
Total stockholders' equity
23,271
43,116
Total liabilities and stockholders’
equity
$
41,666
$
61,730
Athersys, Inc.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
(In Thousands, Except Per Share
Amounts)
Three months ended
Twelve months ended
December 31,
December 31,
2019
2018
2019
2018
Revenues
Contract revenue from Healios
$
251
$
1,267
$
5,517
$
22,276
Royalty and other contract revenue
—
158
—
1,461
Grant revenue
36
89
116
554
Total revenues
287
1,514
5,633
24,291
Costs and expenses
Research and development
7,634
10,167
39,045
38,656
General and administrative
2,448
2,846
11,378
10,442
Depreciation
190
283
698
855
Total costs and expenses
10,272
13,296
51,121
49,953
Gain from insurance proceeds, net
—
234
—
617
Loss from operations
(9,985
)
(11,548
)
(45,488
)
(25,045
)
Other income, net
62
227
906
762
Net loss and comprehensive loss
$
(9,923
)
$
(11,321
)
$
(44,582
)
$
(24,283
)
Net loss per common share — basic and
diluted
$
(0.06
)
$
(0.08
)
$
(0.29
)
$
(0.18
)
Weighted average shares outstanding —
basic and diluted
157,421
142,315
151,696
136,641
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200316005675/en/
William (B.J.) Lehmann President and Chief Operating Officer
Tel: (216) 431-9900 bjlehmann@athersys.com
Karen Hunady Director of Corporate Communications & Investor
Relations Tel: (216) 431-9900 khunady@athersys.com
David Schull Russo Partners, LLC Tel: (212) 845-4271 or (858)
717-2310 David.schull@russopartnersllc.com
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