Company Progressing Neurology and Immunotherapy
Clinical Programs
Asterias Biotherapeutics, Inc. (NYSE American: AST), a
biotechnology company dedicated to developing cell-based
therapeutics to treat neurological conditions associated with
demyelination and cellular immunotherapies to treat cancer, today
reported financial and operational results for the second quarter
ended June 30, 2018, as well as recent corporate progress.
“During the second quarter, we executed on our
primary operational objectives for OPC1 and VAC2, and for the first
time in Asterias’ history we now have two programs in the clinic,
simultaneously,” commented Michael Mulroy, President and Chief
Executive Officer. “Our Phase 1/2a SCiStar study, which
is nearing its conclusion in the next few months, again reaffirmed
OPC1’s positive safety profile, which was demonstrated in the
additional data we reported for Cohorts 3, 4, and 5. We
remain encouraged by the very high rate of cell engraftment we have
seen in the data so far, as well as by the improvement in motor
function for many of the patients. We are now preparing for
discussions with the FDA later this year regarding the design of
the next spinal cord injury trial.
“VAC2 achieved a major milestone in the second
quarter as the first subject in its Phase 1 clinical trial for
non-small cell lung cancer was dosed. Following the positive
outcome from the Safety Review Committee’s review, two additional
patients have been dosed. We continue to work closely with
Cancer Research UK, the trial’s sponsor, and are encouraged by its
commitment to the trial. Cancer Research UK has initiated the
cGMP manufacturing run to manufacture the next lot of VAC2 to be
used in the study. Cancer Research UK has just opened a
second site to support open enrollment following the safety review
meeting that is expected to take place later this quarter.”
“Recently, we have taken some important steps to
further demonstrate the depth of these technology platforms,” added
Mr. Mulroy. “We have initiated pre-clinical collaborations to
evaluate the efficacy of OPC1 to treat stroke and multiple
sclerosis, both demyelinating conditions where there are large,
unmet medical needs. With regard to stroke, we also entered
into an exclusive license agreement with the Regents of the
University of California. Pertaining to our
allogeneic therapeutic vaccine product candidate VAC2, we have held
several KOL meetings focused on additional indications to
potentially pursue. Acute myeloid leukemia (AML) meets much
of our internal criteria and we are considering a study that would
seek to confirm the signal we saw in our previous autologous VAC1
trial as well as examine the safety and efficacy of VAC2 in
combination with an immune checkpoint inhibitor. We plan to
move forward with a pre-IND meeting with the Food and Drug
Administration (FDA) later this year with the goal of filing an
Investigational New Drug (IND) application in the U.S. for VAC2 in
2019,” he concluded.
Second Quarter 2018 and Recent Key
Achievements
OPC1:
OPC1, an oligodendrocyte progenitor cell
population derived from pluripotent stem cells, has been
shown in preclinical testing in animals and in vitro to have three
potentially reparative functions that address the complex
pathologies observed in demyelination disorders, such as spinal
cord injuries, and multiple neurodegenerative diseases, including
multiple sclerosis and white matter stroke. These potential
reparative functions of OPC1 include the production of neurotrophic
factors, the stimulation of vascularization, and the induction of
remyelination of denuded axons, all of which are critical for
survival and regrowth of—and conduction of nerve impulses
through—axons at the injury site. The following operational
achievements have recently occurred for OPC1:
- Asterias reported results from the Company’s ongoing Phase 1/2a
SCiStar study showing six-month (Cohort 5) and 12-month (Cohorts 3
and 4) follow-up data. The data continued to demonstrate that
OPC1 has a positive safety profile and that OPC1 cells are
successfully engrafting in patients, which may have the potential
to improve motor function.
- The Independent Data Monitoring Committee (DMC) for the
Company’s SCiStar Phase 1/2a study of OPC1 in acute spinal cord
injury has completed a regularly scheduled review of the safety
data from all subjects in the five study cohorts and recommended
that the SCiStar study continue according to protocol to its final
data readout.
- Asterias announced exclusive license agreement with The Regents
of the University of California under which Asterias has exclusive
rights in all fields of use for a patent family that claims a
method of improving recovery in a patient that has suffered an
ischemic stroke. This exclusive license agreement is a part of the
Company’s strategy to explore the efficacy of its OPC1 product
candidate in other neurological conditions. The Company has
initiated testing of OPC1 in a second pre-clinical model of
subcortical and white matter ischemia in collaboration with a
leading expert in pre-clinical models of cerebral ischemia and cell
transplantation. The Company has also initiated pre-clinical
testing of OPC1 in multiple sclerosis.
- Asterias expects to request a formal meeting with FDA under the
Regenerative Medicine Advanced Therapy (RMAT) designation
later this month to discuss the continued development of OPC1.
VAC2:
VAC2 is an innovative immunotherapy product that
contains mature dendritic cells derived from pluripotent stem
cells. These non-patient specific (allogeneic) VAC2 cells are
engineered to express a modified form of telomerase, a protein
widely expressed in tumor cells, but rarely found in normal cells.
The modified form of telomerase invokes enhanced stimulation of
immune responses to the protein. Similar to an earlier,
Asterias-sponsored, hematological cancer program using an
autologous approach, the VAC2 dendritic cells instruct the immune
system to generate responses against telomerase and, through this
mechanism, target tumor cells. VAC2’s mode of action is
complementary to and potentially synergistic with other immune
therapies such as checkpoint inhibitors or other immune pathway
inhibitors. The following operational achievements have
recently occurred for VAC2:
- Asterias announced enrollment and dosing of the first subject
in the first-in-human Phase 1 clinical trial of VAC2 in the United
Kingdom. This initial clinical trial, which is being sponsored,
managed and funded by Cancer Research UK, will examine the safety
and tolerability of VAC2 in non-small cell lung cancer as the
study’s primary endpoints.
- Asterias announced positive outcome from a Safety Review
Committee review of the safety and tolerability data generated in
the first clinical trial of VAC2, with recommendation for
continuation of the clinical trial in non-small cell lung
cancer.
- Patients two and three have each been given three of the
scheduled six doses of 10 million VAC2 cells. In August,
Cancer Research UK opened a second site to support enrollment of
the trial.
Second Quarter 2018 Financial Results
Research and development expenses were $3.6
million in the second quarter. General and administrative expenses
were $2.0 million in the second quarter. Total operating expenses
were $5.6 million in the second quarter of 2018, compared to $8.8
million in the second quarter of 2017.
Net loss was $7.0 million, or $0.13 per share,
for the second quarter of 2018 compared to a net loss of $8.7
million, or $0.18 per share, for the second quarter of 2017.
For the quarter ended June 30, 2018, net cash used in operating
activities was $3.2 million compared to $7.0 million for the
quarter ended June 30, 2017.
Cash, cash equivalents, and available-for-sale
securities totaled $14.8 million as of June 30, 2018. The Company
has successfully lowered its quarterly cash burn during the first
half of 2018 and anticipates similar low quarterly cash utilization
for the remainder of 2018.
Conference Call and Webcast Details
The Company will provide an overview of the
second quarter results as well as the recently released SCiStar
data. The conference call is scheduled for 5:00pm ET/2:00pm
PT on Thursday, August 9, 2018. For both "listen-only" participants
and those participants who wish to take part in the
question-and-answer portion of the call, the dial-in number in the
U.S./Canada is 888-599-8686. For international participants outside
the U.S./Canada, the dial-in number is 323-994-2093. For all
callers, refer to Conference ID 7991938. To access the live
webcast, go to
http://asteriasbiotherapeutics.com/inv_events_presentations.php.
A replay of the conference call will be
available for one month beginning about two hours after the
conclusion of the live call, by calling toll-free (from
U.S./Canada) 888-203-1112; international callers dial 719-457-0820.
Use the Conference ID 7991938. Additionally, the archived webcast
will be available at
http://asteriasbiotherapeutics.com/inv_events_presentations.php
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a
biotechnology company dedicated to developing cell-based
therapeutics to treat neurological conditions associated with
demyelination and cellular immunotherapies to treat cancer.
Asterias is presently focused on advancing two clinical-stage
programs which have the potential to address areas of very high
unmet medical need in the fields of neurology and oncology. OPC1
(oligodendrocyte progenitor cells) is currently in a Phase 1/2a
dose escalation clinical trial in spinal cord injury. VAC2
(antigen-presenting allogeneic dendritic cells) is an allogeneic
cancer immunotherapy. The Company's research partner, Cancer
Research UK, has commenced a first-in-human clinical trial of VAC2
in non-small cell lung cancer. Asterias is also sponsoring
pre-clinical work in two conditions with a demyelinating component:
Multiple Sclerosis and White Matter Stroke, and is evaluating other
cancer indications where its immunotherapy platform could provide
therapeutic benefit. Additional information about Asterias can be
found at
www.asteriasbiotherapeutics.com.
FORWARD-LOOKING
STATEMENTSStatements pertaining to future financial and/or
operating and/or clinical research results, future growth in
research, technology, clinical development, and potential
opportunities for Asterias, along with other statements about the
future expectations, beliefs, goals, plans, or prospects expressed
by management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as "will," "believes," "plans,"
"anticipates," "expects," "estimates") should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the businesses of Asterias,
particularly those mentioned in the cautionary statements found in
Asterias' filings with the Securities and Exchange Commission.
Asterias disclaims any intent or obligation to update these
forward-looking statements.
Contacts:Investor
Relations(510) 456-3892InvestorRelations@asteriasbio.comorEVC
Group, Inc.Michael Polyviou/Todd Kehrli(732)
933-2754mpolyviou@evcgroup.com; tkehrli@evcgroup.com
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ASTERIAS BIOTHERAPEUTICS, INC. |
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STATEMENTS OF
OPERATIONS |
(IN THOUSANDS, EXCEPT PER SHARE
DATA) |
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|
Three months ended June 30,
(Unaudited) |
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Six months ended June 30,
(Unaudited) |
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2018 |
|
2017 |
|
2018 |
|
2017 |
REVENUE |
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income |
|
$ |
- |
|
|
$ |
291 |
|
|
$ |
- |
|
|
$ |
2,185 |
|
License
revenue |
|
|
- |
|
|
|
- |
|
|
|
366 |
|
|
|
- |
|
Royalties
from product sales |
|
|
109 |
|
|
|
25 |
|
|
|
221 |
|
|
|
141 |
|
Total
revenue |
|
|
109 |
|
|
|
316 |
|
|
|
587 |
|
|
|
2,326 |
|
Cost of
sales |
|
|
(57 |
) |
|
|
(18 |
) |
|
|
(120 |
) |
|
|
(70 |
) |
Gross
profit |
|
|
52 |
|
|
|
298 |
|
|
|
467 |
|
|
|
2,256 |
|
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EXPENSES |
|
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Research
and development |
|
|
3,617 |
|
|
|
6,984 |
|
|
|
7,243 |
|
|
|
13,582 |
|
General
and administrative |
|
|
1,987 |
|
|
|
1,847 |
|
|
|
3,899 |
|
|
|
6,314 |
|
Total
operating expenses |
|
|
5,604 |
|
|
|
8,831 |
|
|
|
11,142 |
|
|
|
19,896 |
|
|
|
|
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Loss from
operations |
|
|
(5,552 |
) |
|
|
(8,533 |
) |
|
|
(10,675 |
) |
|
|
(17,640 |
) |
|
|
|
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|
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OTHER
INCOME/(EXPENSE) |
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(loss) from change in fair value on warrant liability |
|
|
366 |
|
|
|
(56 |
) |
|
|
1,885 |
|
|
|
2,898 |
|
Loss from
change in fair value of marketable equity securities |
|
|
(1,695 |
) |
|
|
- |
|
|
|
(260 |
) |
|
|
- |
|
Interest
expense, net |
|
|
(95 |
) |
|
|
(114 |
) |
|
|
(201 |
) |
|
|
(239 |
) |
Other
expense, net |
|
|
(6 |
) |
|
|
(25 |
) |
|
|
(43 |
) |
|
|
(34 |
) |
Total
other income (expense), net |
|
|
(1,430 |
) |
|
|
(195 |
) |
|
|
1,381 |
|
|
|
2,625 |
|
|
|
|
|
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|
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|
|
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NET LOSS |
|
$ |
(6,982 |
) |
|
$ |
(8,728 |
) |
|
$ |
(9,294 |
) |
|
$ |
(15,015 |
) |
|
|
|
|
|
|
|
|
|
|
|
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BASIC AND DILUTED NET
LOSS PER SHARE |
|
$ |
(0.13 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
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WEIGHTED AVERAGE SHARES
OUTSTANDING: BASIC AND DILUTED |
|
|
55,138 |
|
|
|
48,511 |
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|
|
54,664 |
|
|
|
48,129 |
|
|
|
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ASTERIAS BIOTHERAPEUTICS, INC. |
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CONDENSED BALANCE
SHEETS |
(IN THOUSANDS, EXCEPT PAR VALUE
AMOUNTS) |
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June 30, 2018
(Unaudited) |
|
December
31, 2017 |
ASSETS |
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CURRENT ASSETS |
|
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|
|
Cash and
cash equivalents |
|
$ |
9,217 |
|
|
$ |
13,166 |
|
Marketable equity securities |
|
|
5,588 |
|
|
|
8,329 |
|
Prepaid
expenses and other current assets |
|
|
1,083 |
|
|
|
1,221 |
|
Total
current assets |
|
|
15,888 |
|
|
|
22,716 |
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
Intangible assets, net |
|
|
14,101 |
|
|
|
15,444 |
|
Property,
plant and equipment, net |
|
|
4,030 |
|
|
|
4,543 |
|
Other
assets |
|
|
324 |
|
|
|
389 |
|
TOTAL ASSETS |
|
$ |
34,343 |
|
|
$ |
43,092 |
|
|
|
|
|
|
|
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LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
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CURRENT
LIABILITIES |
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
1,827 |
|
|
$ |
2,958 |
|
Capital
lease liability, current |
|
|
7 |
|
|
|
7 |
|
Lease
liability, current |
|
|
597 |
|
|
|
556 |
|
Total
current liabilities |
|
|
2,431 |
|
|
|
3,521 |
|
|
|
|
|
|
|
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NONCURRENT
LIABILITIES |
|
|
|
|
|
|
Warrant
liability |
|
|
872 |
|
|
|
2,757 |
|
Capital
lease liability, noncurrent |
|
|
11 |
|
|
|
14 |
|
Deferred
rent |
|
|
325 |
|
|
|
316 |
|
Lease liability,
noncurrent |
|
|
2,632 |
|
|
|
2,941 |
|
TOTAL LIABILITIES |
|
|
6,271 |
|
|
|
9,549 |
|
|
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STOCKHOLDERS’
EQUITY |
|
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|
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|
Preferred
Stock, $0.0001 par value, authorized 5,000 shares; none issued and
outstanding |
|
|
- |
|
|
|
- |
|
Common
Stock, $0.0001 par value, authorized 75,000 Series A Common Stock
and 75,000 Series B Common Stock; 55,509 and 54,051 shares Series A
Common Stock issued and outstanding at June 30, 2018 and December
31, 2017, respectively; no Series B Common Stock issued and
outstanding at June 30, 2018 and December 31, 2017 |
|
|
6 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
155,873 |
|
|
|
152,136 |
|
Accumulated other comprehensive loss |
|
|
- |
|
|
|
(6,498 |
) |
Accumulated deficit |
|
|
(127,807 |
) |
|
|
(112,100 |
) |
Total
stockholders’ equity |
|
|
28,072 |
|
|
|
33,543 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
34,343 |
|
|
$ |
43,092 |
|
|
|
|
|
|
Grafico Azioni Asterias Biotherapeutics, Inc. (AMEX:AST)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Asterias Biotherapeutics, Inc. (AMEX:AST)
Storico
Da Mag 2023 a Mag 2024