FREMONT, Calif., March 29, 2016 /PRNewswire/ -- Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company
focused on the emerging field of regenerative medicine, today
reported financial results for the fourth quarter and year ended
December 31, 2015, as well as key
corporate highlights.
"Asterias has three promising clinical-stage therapeutic
programs based on our immunotherapy and pluripotent stem cell
platform technologies. These pioneering cell therapy programs
have the potential to address areas of very high unmet medical need
in the fields of oncology and neurology. We are focused on
continuing to advance all three therapeutic programs through
clinical development," said Steve
Cartt, President and Chief Executive Officer of
Asterias.
The Company recently completed the End-of-Phase 2 meeting with
the U.S. Food and Drug Administration (FDA) for AST-VAC1, the
company's lead clinical program targeting maintenance of
relapse-free-survival in acute myeloid leukemia (AML) patients.
Asterias is planning for the initiation of a single pivotal Phase 3
trial that could support an accelerated development pathway towards
a potential future biologic license application (BLA) filing.
The company's second clinical-stage program, AST-VAC2, will be
investigated in a planned Phase 1/2 trial in non-small cell lung
cancer that will be sponsored, managed and funded by the company's
development partner, Cancer Research UK (CRUK). This study is
expected to begin enrollment in early 2017.
The company's third clinical program, AST-OPC1, has successfully
completed the initial 2 million cell safety cohort and is currently
enrolling patients for the 10 million cell second cohort in a Phase
1/2a clinical trial in complete cervical spinal cord injury. This
trial is being funded in part by a $14.3
million grant from the California Institute of Regenerative
Medicine.
"We look forward to achieving further progress on these
pioneering cell therapy clinical programs, including important
clinical and other development milestones, during the remainder of
2016 and into 2017," Mr. Cartt concluded.
Research and Development Highlights:
Since Asterias released third quarter results in November 2015, the Company has reported the
following progress:
AST-VAC1 (antigen-presenting autologous dendritic
cells)
- Asterias successfully completed an End-of-Phase 2 meeting with
the U.S. FDA for AST-VAC1, its investigational cancer immunotherapy
targeting AML. During the meeting, the FDA indicated general
agreement with Asterias' proposed development plan for registration
of AST-VAC1 through a single Phase 3 trial to support an
accelerated development pathway and BLA filing. In this study,
Asterias will assess the impact of AST-VAC1 compared to placebo on
the duration of relapse-free-survival as the primary endpoint, and
on overall survival as the secondary endpoint in patients who have
achieved complete remission using standard therapies. The Company
currently plans to submit a request for a Special Protocol
Assessment to the FDA to confirm the primary endpoint and other
design elements of this pivotal Phase 3 trial.
- The Phase 2 clinical trial data discussed with FDA was
previously presented at the 2015 ASCO annual meeting. Nineteen AML
patients in complete remission (16 CR1 and 3 CR2) received
AST-VAC1. The duration of relapse-free survival was greater after
AST-VAC1 treatment as compared to that of historical controls.
Eleven of 19 (58%) patients (median follow-up 52 mos.) remained in
remission as of last follow-up. Of the 19 CR patients, seven were ≥
60 years old at the time of AST-VAC1 immunotherapy and were at
high-risk for recurrence. Four of the seven (57%) patients ≥ 60
years old remained relapse free 52 to 59 months post AST-VAC1
immunotherapy. The results suggest that immunotherapy with AST-VAC1
is safe and may extend relapse-free survival even in patients with
high risk AML.
AST-VAC2 (antigen-presenting allogeneic dendritic
cells)
- Asterias completed the transfer of its manufacturing processes
for production of AST-VAC2, the company's innovative immunotherapy
product that contains mature dendritic cells derived from
pluripotent stem cells, to Cancer Research UK (CRUK). To accelerate
clinical development of AST-VAC2, Asterias has an ongoing
partnership with CRUK and Cancer Research Technology, the charity's
development and commercialization arm, to execute the first
clinical trial of AST-VAC2. As part of this partnership, CRUK will
perform cGMP manufacture of AST-VAC2 at its Biotherapeutics
Development Unit, and will submit a Clinical Trial Authorisation
application to the UK regulatory authorities for a Phase 1/2
clinical trial in non-small cell lung cancer. The trial will be
sponsored, managed and funded by CRUK's Centre for Drug
Development. The clinical trial will examine the safety,
immunogenicity and activity of AST-VAC2 and may position the
immunotherapy to be tested for numerous clinical indications.
AST-OPC1 (oligodendrocyte progenitor cells)
- The FDA granted Orphan Drug Designation for AST-OPC1, Asterias'
product development candidate based on its pluripotent stem cell
technology platform, for the treatment of acute spinal cord injury.
Orphan Drug designation is a special status that the FDA may grant
a drug intended to treat a rare disease or condition. Orphan Drug
Designation qualifies the sponsor of the drug certain benefits and
incentives, including seven years of marketing exclusivity
following regulatory approval, and financial incentives such as
potential tax credits for certain activities and waiver of certain
administrative fees.
Corporate Highlights
- In February, pharmaceutical industry veteran Stephen L. Cartt was appointed as President and
Chief Executive Officer of Asterias, and member of the company's
Board of Directors. Mr. Cartt previously served as Chief Operating
Officer of Questcor Pharmaceuticals Inc. until its sale in 2014 to
Mallinckrodt, plc. In addition,
Don M. Bailey was appointed to
Asterias' Board of Directors and named Chairman of the Board of
Directors. Mr. Bailey previously served as President and Chief
Executive Officer of Questcor until its sale in 2014 to
Mallinckrodt, plc.
- In February, Asterias simplified its capital structure through
an asset swap with BioTime, Inc. BioTime acquired from Asterias
shares of capital stock of BioTime subsidiaries Cell Cure
Neurosciences Ltd and OrthoCyte Corporation. Asterias acquired from
BioTime warrants to purchase 3,150,000 shares of Asterias Series A
Common Stock. In addition, the companies entered into a patent
cross-license agreement for pluripotent stem cell-derived cell
therapies and other potential uses, which allows both companies the
freedom to leverage a large patent estate covering the therapeutic
uses of pluripotent stem cell technology.
Fourth Quarter and Full Year 2015 Financial Results
Cash Position and Usage: Asterias had cash and cash
equivalents of $11.2 million as of
December 31, 2015, compared to
$3.1 million as of December 31, 2014. At December 31, 2015, Asterias held approximately
$17 million in available-for-sale
securities. For the fourth quarter, net cash used in operating
activities was $4.0 million.
Revenues: Total revenues were $608,000 for the fourth quarter and $3.6 million for the full year ended December 31, 2015. Revenues are comprised of
grant income as well as royalty revenues on product sales by
licensees. Grant income in 2015 was entirely from the California
Institute for Regenerative Medicine (CIRM). CIRM is disbursing
funds under the grant award to Asterias over four years through
2018 in accordance with a quarterly disbursement schedule, subject
to attainment of certain progress and safety milestones.
R&D Expenses: Research and development expenses were
$5.4 million for the fourth quarter
and $17.3 million for the full year
ended December 31, 2015, compared to
$5.4 million and $13.3 million for the comparable periods in
2014.
G&A Expenses: General and administrative expenses
were $2.8 million for the fourth
quarter and $7.9 million for the full
year of 2015, compared to $1.2
million and $5.3 million for
the comparable periods in 2014.
Net Loss: Net loss was $4.9
million for the three months ended December 31, 2015, or $0.13 per share, including deferred income tax
benefits of $2.9 million. For the
full year ended December 31, 2015,
net loss was $15.0 million or
$0.42 per share, including deferred
income tax benefits of $7.3 million.
For the comparable periods in 2014, fourth quarter net loss was
$3.3 million, or $0.11 per share, including deferred income tax
benefits of $2.2 million, and full
year net loss was $10.1 million or
$0.33 per share, including deferred
income tax benefits of $7.4
million.
Conference Call and Webcast Details
Asterias will host a conference call and webcast today,
Tuesday, March 29, 2016, at
4:30 p.m. ET/1:30 p.m. PT to discuss financial and operating
results and recent corporate developments.
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 800-768-6563. For international
participants outside the U.S./Canada, the dial-in number is 785-830-7991.
For all callers, refer to Conference ID 8993084. To access the live
webcast, go to
http://asteriasbiotherapeutics.com/events-presentations/.
A replay of the conference call will be available for seven
business days 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 8993084. Additionally, the
archived webcast will be available at
http://asteriasbiotherapeutics.com/events-presentations/.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a leading biotechnology
company in the emerging field of regenerative medicine. The
company's proprietary, industry leading platforms are based on its
pluripotent stem cell and dendritic cell immunotherapy
technologies. Asterias is focused on developing therapies to treat
conditions in several medical areas where there is high unmet
medical need and inadequate available therapies. AST-OPC1
(oligodendrocyte progenitor cells) is currently in a Phase 1/2a
dose escalation clinical trial in spinal cord injury. AST-VAC1
(antigen-presenting autologous dendritic cells) has demonstrated
promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2
(antigen-presenting allogeneic dendritic cells) represents a second
generation, allogeneic approach to dendritic cell vaccines.
Additional information about Asterias can be found at
www.asteriasbiotherapeutics.com.
Forward Looking Statements
Statements pertaining to future financial and/or operating
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" and "potential") 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, whether we
can obtain regulatory approvals and the timing of such approvals,
whether we can attain certain progress and safety milestones
required under our grant awards, our 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's filings with the Securities and Exchange
Commission. Asterias disclaims any intent or obligation to update
these forward-looking statements.
ASTERIAS
BIOTHERAPEUTICS, INC.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(IN THOUSANDS,
EXCEPT PER SHARE DATA)
|
|
|
|
Three months ended
December 31,
|
|
|
|
|
(unaudited)
|
|
Year ended
December 31,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
REVENUE
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties from
product sales
|
|
$
|
8
|
|
$
|
12
|
|
$
|
535
|
|
$
|
189
|
Sale of cell
lines
|
|
|
-
|
|
|
10
|
|
|
40
|
|
|
-
|
Grant
income
|
|
|
600
|
|
|
1,034
|
|
|
3,007
|
|
|
1,035
|
Total
revenues
|
|
|
608
|
|
|
1,056
|
|
|
3,582
|
|
|
1,224
|
Cost of
sales
|
|
|
(3)
|
|
|
(11)
|
|
|
(268)
|
|
|
(95)
|
Total gross
profit
|
|
$
|
605
|
|
$
|
1,045
|
|
$
|
3,314
|
|
$
|
1,129
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
(5,403)
|
|
$
|
(5,400)
|
|
$
|
(17,321)
|
|
$
|
(13,310)
|
General and
administrative
|
|
|
(2,830)
|
|
|
(1,172)
|
|
|
(7,901)
|
|
|
(5,280)
|
Total operating
expenses
|
|
|
(8,233)
|
|
|
(6,572)
|
|
|
(25,222)
|
|
|
(18,590)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(7,628)
|
|
|
(5,527)
|
|
|
(21,908)
|
|
|
(17,461)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
|
(143)
|
|
|
-
|
|
|
(341)
|
|
|
(10)
|
Other expense,
net
|
|
|
-
|
|
|
-
|
|
|
(6)
|
|
|
(2)
|
Total other
expenses
|
|
|
(143)
|
|
|
-
|
|
|
(347)
|
|
|
(12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE DEFERRED
INCOME TAX BENEFIT
|
|
|
(7,771)
|
|
|
(5,527)
|
|
|
(22,255)
|
|
|
(17,473)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax
benefit
|
|
|
2,866
|
|
|
2,201
|
|
|
7,252
|
|
|
7,376
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
|
(4,905)
|
|
|
(3,326)
|
|
|
(15,003)
|
|
|
(10,097)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available for sales
investments: Change in other unrealized gain/(loss), net of
taxes
|
|
|
2,766
|
|
|
2,541
|
|
|
937
|
|
|
2,432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE
LOSS
|
|
$
|
(2,139)
|
|
$
|
(785)
|
|
$
|
(14,066)
|
|
$
|
(7,665)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.13)
|
|
$
|
(0.11)
|
|
$
|
(0.42)
|
|
$
|
(0.33)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding used to compute net loss per common
share, basic and diluted
|
|
|
37,818
|
|
|
30,901
|
|
|
35,443
|
|
|
30,720
|
|
ASTERIAS
BIOTHERAPEUTICS, INC.
|
|
|
|
BALANCE
SHEETS
|
|
(IN THOUSANDS,
EXCEPT PAR VALUE AMOUNTS)
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
2015
|
2014
|
|
ASSETS
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
11,183
|
|
|
$
|
3,076
|
|
Available-for-sale
securities, at fair value
|
|
|
17,006
|
|
|
|
14,374
|
|
Grant
receivable
|
|
|
-
|
|
|
|
118
|
|
Landlord
receivable
|
|
|
567
|
|
|
|
378
|
|
Prepaid expenses and
other current assets
|
|
|
1,033
|
|
|
|
438
|
|
Total
current assets
|
|
|
29,789
|
|
|
|
18,384
|
|
|
|
|
|
|
|
|
|
|
NONCURRENT
ASSETS
|
|
|
|
|
|
|
|
|
Intangible assets,
net
|
|
|
20,816
|
|
|
|
23,502
|
|
Property, plant and
equipment, net
|
|
|
5,756
|
|
|
|
1,045
|
|
Construction in
progress
|
|
|
-
|
|
|
|
406
|
|
Investment in
affiliates
|
|
|
416
|
|
|
|
416
|
|
Deferred tax
asset
|
|
|
9,744
|
|
|
|
-
|
|
Other
assets
|
|
|
457
|
|
|
|
361
|
|
Total
noncurrent assets
|
|
|
37,189
|
|
|
|
25,730
|
|
TOTAL
ASSETS
|
|
$
|
66,978
|
|
|
$
|
44,114
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Amount due to parent,
BioTime, Inc.
|
|
$
|
530
|
|
|
$
|
615
|
|
Accounts
payable
|
|
|
747
|
|
|
|
737
|
|
Accrued liabilities
and other current liabilities
|
|
|
1,183
|
|
|
|
430
|
|
Capital lease
liability
|
|
|
7
|
|
|
|
-
|
|
Deferred rent
liability
|
|
|
-
|
|
|
|
2
|
|
Deferred grant
income
|
|
|
2,513
|
|
|
|
-
|
|
Deferred tax
liabilities, current portion
|
|
|
5,274
|
|
|
|
4,713
|
|
Total
current liabilities
|
|
|
10,254
|
|
|
|
6,497
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES
|
|
|
|
|
|
|
|
|
Capital lease
liability
|
|
|
26
|
|
|
|
-
|
|
Deferred tax
liabilities, net of current portion
|
|
|
7,020
|
|
|
|
4,514
|
|
Deferred rent
liability, net of current portion
|
|
|
179
|
|
|
|
94
|
|
Lease
liability
|
|
|
4,400
|
|
|
|
378
|
|
TOTAL
LIABILITIES
|
|
|
21,879
|
|
|
|
11,483
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Preferred Stock,
$0.0001 par value, authorized 5,000,000 shares; none issued and
outstanding
|
|
|
-
|
|
|
|
-
|
|
Common Stock,
authorized 75,000 Series A Common Stock, $0.0001 par value, and
75,000 Series B Common Stock; 38,228 and 30,902 shares Series A
Common Stock issued and outstanding at December 31, 2015 and 2014;
no Series B Common Stock issued and outstanding at December 31,
2015 and 2014.
|
|
|
4
|
|
|
|
3
|
|
Additional paid-in
capital
|
|
|
92,900
|
|
|
|
66,367
|
|
Accumulated
comprehensive gain (loss) on available-for-sale
investments
|
|
|
434
|
|
|
|
(503)
|
|
Accumulated
Deficit
|
|
|
(48,239)
|
|
|
|
(33,236)
|
|
Total
stockholders' equity
|
|
|
45,099
|
|
|
|
32,631
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$
|
66,978
|
|
|
$
|
44,114
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/asterias-biotherapeutics-reports-fourth-quarter-and-full-year-2015-financial-results-and-reviews-the-companys-three-clinical-stage-cell-therapy-programs-300242822.html
SOURCE Asterias Biotherapeutics, Inc.