Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine
company developing MultiStem® (invimestrocel) cell therapy for
critical care indications, announced financial results for the
three and six months ended June 30, 2023 and provided a business
update.
Second Quarter 2023 and Recent Corporate and Operational
Highlights:
- Nominated healthcare executive and strategy consultant Neema
Mayhugh, Ph.D. to the Company’s Board of Directors
- Surpassed two-thirds patient enrollment in the MASTERS-2
clinical trial with MultiStem for ischemic stroke
- Completed Memorandum of Understanding with Healios to provide
consulting support with PMDA to explore the feasibility of adding
Japanese patients to MASTERS-2 trial
- Presented as a finalist for the Biomedical Advanced Research
and Development Authority’s (BARDA) “Just Breathe” program for a
proposed clinical trial with MultiStem for acute respiratory
distress syndrome (ARDS) and other COVID-19 co-morbidities
- Initiated enrollment of cohort 3 in the MATRICS-1 clinical
trial with MultiStem for trauma using 3-D bioreactor manufactured
clinical product
- Raised $3.7 million through a registered direct offering with
institutional investors
- Continued reducing expenses to conserve cash and heightened
focus on execution of MASTERS-2 trial
- Maintained operating expenses below $2.5 million per month
- Participated in several industry conferences to build awareness
of Athersys and share MultiStem clinical and manufacturing
progress, including:
- The American Society for Neural Therapy and Repair Annual
Conference
- Cellular Therapies and Transfusion Medicine in Trauma and
Critical Care Conference
- Pharma Manufacturing World Summit
- Allogeneic Cell Therapies Summit
- American Thoracic Society’s Respiratory Innovation Summit
Management Commentary
“The second quarter of 2023 was marked by improved execution on
all fronts, from continuing to maintain low operating expenses to
improved enrollment in our ongoing clinical trials, including the
start of cohort 3 enrollment in our MATRICS-1 trauma trial
following a positive DSMB review. We also implemented the MASTERS-2
protocol changes agreed upon with the U.S. FDA in more than 60% of
our trial sites with the remainder expected to be completed by the
end of August. These protocol modifications now reflect the full
potential benefit of MultiStem for patients with acute,
moderate-to-severe ischemic stroke as well as the evolving standard
of care. In addition, the FDA approved our request to conduct an
unblinded interim analysis to evaluate whether the study size is
sufficiently powered to achieve statistical significance. We look
forward to sharing these results in early October,” said Daniel
Camardo, Chief Executive Officer of Athersys.
Second Quarter Results
There was $48.8 thousand of revenue for the second quarter of
2023 compared with $2.3 million for the second quarter of 2022,
which included the delivery of services under the arrangement with
Healios. As of September 30, 2022, services under this arrangement
were largely complete and were limited to close-out activities.
Research and development expenses were $10.6 million for the
second quarter of 2023 compared with $20.8 million for the
comparable period in 2022. The decrease reflects our restructuring
plan which resulted in reduced clinical trial expenses which
includes personnel, manufacturing, and other costs.
General and administrative expenses were $2.3 million for the
second quarter of 2023 compared with $5.2 million for the
comparable period in 2022, with the decrease primarily due to the
restructuring.
Net loss for the second quarter of 2023 was $(12.9) million, or
$(0.62) per share, compared with a net loss of $(23.6) million, or
$(2.28) per share, for the comparable period in 2022.
Cash and cash equivalents were $1.8 million as of June 30, 2023,
compared with $9.0 million as of December 31, 2022.
About MultiStem®
MultiStem® (invimestrocel) cell therapy is a patented
regenerative medicine product in clinical development that has
shown the ability to promote tissue repair and healing in a variety
of ways, such as through the production of therapeutic factors in
response to signals of inflammation and tissue damage. MultiStem
therapy’s potential for multidimensional therapeutic impact
distinguishes it from traditional biopharmaceutical therapies
focused on a single mechanism of benefit. The therapy represents a
unique "off-the-shelf" stem cell product that can be manufactured
in a scalable manner, may be stored for years in frozen form, and
is administered without tissue matching or the need for immune
suppression. Based upon its efficacy profile, its novel mechanisms
of action, and a favorable and consistent tolerability demonstrated
in clinical studies, we believe that MultiStem therapy could
provide a meaningful benefit to patients, including those suffering
from serious diseases and conditions with unmet medical need.
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, 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 MultiStem cell therapy toward
commercialization. Investors and others should note that we may
post information about the Company on our website at
www.athersys.com and/or on our accounts on Twitter, Facebook,
LinkedIn or other social media platforms. It is possible that the
postings could include information deemed to be material
information. Therefore, we encourage investors, the media and
others interested in the Company to review the information we post
on our website at www.athersys.com and on our social media
accounts. Follow Athersys on Twitter at www.twitter.com/athersys.
Information that we may post about the Company on our website
and/or on our accounts on Twitter, Facebook, LinkedIn or other
social media platforms may contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve risks and uncertainties. You should not place
undue reliance on forward-looking statements contained on our
website and/or on our accounts on Twitter, Facebook, LinkedIn or
other social media platforms, and we undertake no obligation to
publicly update forward-looking statements, whether as a result of
new information, future events or otherwise.
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, expected timetable for
any results of our trials or analyses, 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. In addition, 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 are the risk that we will be
unable to raise capital to fund our operations in the near term and
long term, including our ability to obtain funding through public
or private equity offerings, debt financings, collaborations and
licensing arrangements or other sources, on terms acceptable to us
or at all, and to continue as a going concern. The following risks
and uncertainties 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: our ability to
raise capital to fund our operations in the near term and long
term, including our ability to obtain funding through public or
private equity offerings, debt financings, collaborations and
licensing arrangements or other sources, on terms acceptable to us
or at all, and to continue as a going concern; whether we receive a
grant from BARDA; our collaborators’ ability and willingness to
continue to fulfill their obligations under the terms of our
collaboration agreements and generate sales related to our
technologies; the possibility of unfavorable results from ongoing
and additional clinical trials involving MultiStem; the risk that
positive results in a clinical trial may not be replicated in
subsequent or confirmatory trials or success in an early stage
clinical trial may not be predictive of results in later stage or
large scale clinical trials; our ability to successfully license
our SIFU technology; our ability to regain and maintain compliance
with the Nasdaq continued listing requirements; the timing and
nature of results from MultiStem clinical trials, including the
MASTERS-2 Phase 3 clinical trial evaluating the administration of
MultiStem for the treatment of ischemic stroke; our ability to meet
milestones and earn royalties under our collaboration agreements,
including the success of our collaboration with Healios; the
success of our MACOVIA clinical trial evaluating the administration
of MultiStem for the treatment of ARDS induced by COVID-19 and
other pathogens, and the MATRICS-1 clinical trial being conducted
with The University of Texas Health Science Center at Houston
evaluating the treatment of patients with serious traumatic
injuries; the availability of product sufficient to meet our
clinical needs and potential commercial demand following any
approval; 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 or us, such as due
to material supply constraints, contamination, operational
restrictions due to COVID-19 or other public health emergencies,
labor constraints, regulatory issues or other factors that 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 neurological, inflammatory and immune, cardiovascular
and other critical care 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; 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; the success of our competitors and the
emergence of new competitors; and the risks mentioned elsewhere in
our Annual Report on Form 10-K for the year ended December 31, 2022
under Item 1A, “Risk Factors” and our other filings with the SEC.
You should not place undue reliance on forward-looking statements,
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
(In thousands)
June 30,
2023
December 31,
2022
(Unaudited)
(Note)
Assets
Cash and cash equivalents
$
1,803
$
9,038
Accounts receivable from Healios, billed
and unbilled
664
716
Prepaid expenses, deposits and other
1,225
3,781
Operating right-of-use assets, net
38
7,846
Property and equipment, net
4,644
4,214
Deposits and other
2,114
2,136
Total assets
$
10,477
$
27,731
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other current liabilities
$
10,805
$
37,164
Deferred revenue - Healios
7,862
8,685
Operating lease liabilities
8,390
534
Warrant liability
—
5,199
Advance from Healios
5,199
—
Note Payable
15,640
—
Total stockholders' equity
(37,419
)
(23,851
)
Total liabilities and stockholders'
equity
$
10,477
$
27,731
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
June 30,
2023
2022
Revenues
Contract revenue from Healios
$
49
$
2,316
Total revenues
49
2,316
Costs and expenses
Research and development
10,649
20,794
General and administrative
2,345
5,162
Depreciation
43
618
Total costs and expenses
13,037
26,574
Loss from operations
(12,988
)
(24,258
)
Other income, net
64
610
Net loss and comprehensive loss
$
(12,924
)
$
(23,648
)
Net loss per share, basic and diluted
$
(0.62
)
$
(2.28
)
Weighted average shares outstanding, basic
and diluted
20,700
10,383
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230816907178/en/
Athersys Ellen Gurley Manager of Corporate Communications
and Investor Relations ir@athersys.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
Athersys (NASDAQ:ATHX)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Athersys (NASDAQ:ATHX)
Historical Stock Chart
Von Mai 2023 bis Mai 2024