Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine
company developing MultiStem® (invimestrocel) cell therapy for
critical care indications, announced on Monday, May 15th financial
results for the three months ended March 31, 2023 and provided a
business update.
First Quarter 2023 and Recent Corporate and Operational
Highlights
- Continued reducing expenses to conserve cash and heightened
focus on MASTERS-2 trial, thereby making Athersys more attractive
to potential financial and strategic partners
- Maintained operating expenses below $2.5 million per month
- Raised $3.7 million through a registered direct offering with
institutional investors
- Appointed biotechnology and pharmaceutical executive Joseph
Nolan to the Board of Directors
- Participated in Request for Proposal (RFP) process with the
Biomedical Advanced Research and Development Authority (BARDA) for
a proposed clinical trial with MultiStem for acute respiratory
distress syndrome (ARDS) and other COVID-19 co-morbidities
- Completed DSMB review of cohort 1 & 2 of MATRICS trauma
trial using both cell factory and bioreactor manufactured clinical
product
- Awarded a U.S. patent for the novel SIFU® cryogenic storage
system, the Company’s user-friendly system to improve storage and
handling of cryogenic products in hospital settings
MASTERS-2
- Amended the clinical trial protocol reflecting modifications
proposed during a Type B meeting with the U.S. FDA that best
reflect the potential benefits of MultiStem in treating acute,
moderate-to-severe, ischemic stroke; protocol modifications
include:
- Primary endpoint assessed by shift analysis in modified Rankin
Scale (mRS) score was changed to Day 365, from Day 90
previously
- Shift analysis in mRS score at Day 90 is retained as a key
secondary endpoint
- Eligibility caps on concomitant reperfusion therapy (e.g., tPA,
MR or tPA+MR) were removed to ensure the study population
appropriately reflects the evolving standard of care in ischemic
stroke treatment
- Added the option to conduct an interim analysis for powering to
confirm 300 patient sample size is adequate to achieve statistical
significance with new primary endpoint
Medical Affairs
- Athersys executives participated in several industry
conferences to build awareness of Athersys and share clinical and
manufacturing progress achieved with MultiStem, including:
- Advanced Therapies Week presented by Phacilitate
- 2nd Allogeneic Cell Therapies Summit Europe
- International Stroke Conference 2023
- BioProcess International US West
- The American Society for Neural Therapy and Repair Annual
Conference
- Cellular Therapies and Transfusion Medicine in Trauma and
Critical Care Conference
Management Commentary
“We entered 2023 with greater clarity and confidence on our path
forward with MultiStem, having largely completed a significant
restructuring in the second half of last year that reduced our
operating expenses below $2.5 million per month. In addition,
achieving a successful Type B meeting with the FDA on proposed
MASTERS-2 trial modifications will now more appropriately represent
the regenerative benefits of MultiStem over a longer period and
reflect changes we’ve observed in ischemic stroke standard of care.
We’ve also made meaningful progress with trial enrollment and
advanced conversations with multiple parties exploring business
development opportunities with MultiStem as well as our animal
health franchise and SIFU,” said Dan Camardo, Chief Executive
Officer of Athersys. “We have more work to do, but I’m encouraged
by the progress we’ve made and the catalysts we are working toward
in the coming year.”
First Quarter Results
There was no revenue for the first quarter of 2023 compared with
$2.9 million for the first 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 $4.5 million for the
first quarter of 2023 compared with $20.9 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 $2.8 million for the
first quarter of 2023 compared with $4.1 million for the comparable
period in 2022, with the decrease primarily due to the
restructuring. The Company expects further decreases in general and
administrative expenses.
Net loss for the first quarter of 2023 was $7.8 million, or
$0.43 per share, compared with a net loss of $22.2 million, or
$2.27 per share, for the comparable period in 2022.
Cash and cash equivalents were $3.1 million as of March 31, 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, 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 and our ability to
successfully resolve the payment issues with our primary contract
manufacturer and gain access to our clinical product. 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; our ability to successfully license our SIFU
technology; our ability to successfully resolve the payment issues
with our primary contract manufacturer and gain access to our
clinical product 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 regain 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, 2021
under Item 1A, “Risk Factors” and our other lings 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)
March 31, 2023
December 31,
2022
(Unaudited)
(Note)
Assets
Cash and cash equivalents
$
3,121
$
9,038
Accounts receivable from Healios, billed
and unbilled
716
716
Prepaid expenses, deposits and other
3,999
3,781
Operating right-of-use assets, net
7,591
7,846
Property and equipment, net
4,079
4,214
Deposits and other
2,126
2,136
Total assets
$
21,632
$
27,731
Liabilities and stockholders’
equity
Accounts payable, accrued expenses and
other current liabilities
$
37,844
$
37,164
Operating lease liabilities
8,437
8,685
Warrant liability
1,163
534
Advance from Healios
5,199
5,199
Other long-term liabilities
—
—
Total stockholders' equity
(31,011
)
(23,851
)
Total liabilities and stockholders'
equity
$
21,632
$
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
March 31,
2023
2022
Revenues
Contract revenue from Healios
$
—
$
2,912
Total revenues
—
2,912
Costs and expenses
Research and development
4,467
20,944
General and administrative
2,815
4,099
Depreciation
52
247
Total costs and expenses
7,334
25,290
Loss from operations
(7,334
)
(22,378
)
Other income, net
(477
)
162
Net loss and comprehensive loss
$
(7,811
)
$
(22,216
)
Net loss per share, basic and diluted
$
(0.43
)
$
(2.27
)
Weighted average shares outstanding, basic
and diluted
18,292
9,768
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version on businesswire.com: https://www.businesswire.com/news/home/20230518005552/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)
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