- Moves into new San Francisco Bay Area R&D facility,
comprising approximately 15,700-square-feet of office and lab
space, including cGMP-capable manufacturing suite.
- Strengthens leadership at Board level by appointment of
regenerative medicine leader Dr. Michael H. May, CEO of Canada’s
Centre for Commercialization of Regenerative Medicine (CCRM).
- Begins work using synthetic biology approach to engineer
pluripotent stem cell lines with immune tolerance UniverCyte™
technology to generate hypoimmunogenic (universal) cells.
- CEO Dr. Michael D. West featured in cover story Special Report
in New Scientist magazine, “A Cure for Aging?”
AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a
biotechnology company focused on the development of therapeutics
for human aging, reported financial and operating results for the
second quarter ended June 30, 2019.
“In the second quarter we executed the complete relocation of
our facilities including the construction of cGMP-capable
therapeutics manufacturing space. We plan to utilize this new
capability to produce clinical-grade master cell banks using our
UniverCyte™ technology, as well as AGEX-BAT1 and AGEX-VASC1 that
may be used in the future in clinical trials,” said Michael D.
West, Ph.D., founder and Chief Executive Officer. “In addition, we
have prioritized the advancement of our induced Tissue Regeneration
(iTR) technology which is increasingly recognized by the industry
as a potentially transformative platform technology for the
treatment of human aging. Our appointment of Dr. Michael May to our
Board of Directors will contribute to attaining our goal of leading
the industry in the field of the biotechnology of aging. Lastly, we
appreciate the support of our largest shareholder Juvenescence,
Limited that provided a $2 million loan facility demonstrating
their continued support of our product development. We are
fortunate to have Juvenescence, which itself has raised over $110
million since 2017, as our key backer.”
“This is an exceptionally exciting time for us as we work toward
our goal of becoming a leading biotechnology company in cellular
therapies and human aging,” commented Greg Bailey, M.D.,
Chairperson of the Board of Directors. “Our commitment to this goal
is demonstrated by us taking up residence in our new R&D
facility as well as making progress in our work to engineer
hypoimmunogenic cells and to move our other programs forward.”
Additional Recent Highlights
- AgeX moved into a new San Francisco Bay Area R&D facility,
comprising approximately 15,700-square-feet of office and lab
space, located at 965 Atlantic Avenue Suite 101, Alameda, CA 94501.
The new facility will house the company’s current staff and can
accommodate for significant future growth. Good Manufacturing
Practice (cGMP) production capability has been established at the
new facility with two additional clean environmental space
laboratories.
- Dr. West and AgeX featured in a cover story in New Scientist
magazine. The influential British science magazine’s Special
Report, “A Cure for Aging?” ran in the April 27th issue.
- The Company participated at three industry and investor
conferences during the quarter. These included a presentation by
Dr. West at Undoing Aging in Berlin, Germany, on AgeX’s
regenerative medicine product development. At the conference, Dr.
West also presented data relating to the central molecular
clockwork mechanisms that AgeX is targeting with its induced iTR
program. Additionally, during the quarter the company presented at
Master Investor Show 2019 in London and Biotech Investing in
Longevity in San Francisco.
- AgeX entered into a Loan Facility Agreement with Juvenescence
Limited, providing AgeX with a $2 million line of credit over the
next 18 months to advance product development.
Balance Sheet Highlights
Cash, cash equivalents, and restricted cash totaled $5.9 million
as of June 30, 2019, as compared with $8.6 million as of the end of
the previous quarter.
Second Quarter 2019 Operating Results
Revenues: Total revenues for the three months ended June 30,
2019 were $380,000, as compared with $464,000 in the same period in
2018. AgeX revenues are primarily generated from subscription and
advertising revenues from the GeneCards® online database through
its subsidiary LifeMap Sciences, Inc. 2019 revenues also included
approximately $47,000 of allowable expenses under its research
grant from the NIH. AgeX had no grant revenues in the same period
in 2018.
Operating expenses: Operating expenses for the three months
ended June 30, 2019 were $3.8 million, as compared with $2.5
million for the same period in 2018. On an as-adjusted basis,
operating expenses for the three months ended June 30, 2019 were
$3.0 million as compared to $2.2 million for the same period in
2018.
The reconciliation between operating expenses determined in
accordance with accounting principles generally accepted in the
United States (GAAP) and operating expenses, as adjusted, a
non-GAAP measure, is provided in the financial tables included at
the end of this press release.
Research and development expenses for the three months ended
June 30, 2019 were $1.7 million, as compared with $1.4 million in
the same period in 2018. The increase was primarily attributable to
an increase in expenses in AgeX programs utilizing PureStem® cell
lines and iTR technology.
General and administrative expenses for the three months ended
June 30, 2019 were $2.1 million, as compared with $1.1 million in
the same period in 2018.
Net loss attributable to AgeX: The net loss attributable to AgeX
for the three months ended June 30, 2019 was $3.1 million, or
($0.08) per share (basic and diluted) compared to $1.9 million, or
($0.06) per share (basic and diluted), for the same period in
2018.
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on
developing and commercializing innovative therapeutics for human
aging. Its PureStem® and UniverCyte™ manufacturing and
immunotolerance technologies are designed to work together to
generate highly defined, universal, allogeneic, off-the-shelf
pluripotent stem cell-derived young cells of any type for
application in a variety of diseases with a high unmet medical
need. AgeX has two preclinical cell therapy programs: AGEX-VASC1
(vascular progenitor cells) for tissue ischemia and AGEX-BAT1
(brown fat cells) for Type II diabetes. AgeX’s revolutionary
longevity platform induced Tissue Regeneration (iTR™) aims to
unlock cellular immortality and regenerative capacity to reverse
age-related changes within tissues. AGEX-iTR1547 is an iTR-based
formulation in preclinical development. HyStem® is AgeX’s delivery
technology to stably engraft PureStem cell therapies in the body.
AgeX is developing its core product pipeline for use in the clinic
to extend human healthspan, and is seeking opportunities to
establish licensing and collaboration arrangements around its broad
IP estate and proprietary technology platforms.
For more information, please visit www.agexinc.com or connect
with the company on Twitter, Facebook, and YouTube.
Forward-Looking Statements
Certain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. 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 forward-looking
statements. Forward-looking statements involve risks and
uncertainties. 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 business of AgeX Therapeutics, Inc. and its
subsidiaries, particularly those mentioned in the cautionary
statements found in more detail in the “Risk Factors” section of
AgeX’s Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commissions (copies of
which may be obtained at www.sec.gov). Subsequent events and
developments may cause these forward-looking statements to change.
AgeX specifically disclaims any obligation or intention to update
or revise these forward-looking statements as a result of changed
events or circumstances that occur after the date of this release,
except as required by applicable law.
AGEX THERAPEUTICS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS, EXCEPT PAR
VALUE AMOUNTS)
June 30, 2019
December 31, 2018
(Unaudited)
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
5,813
$
6,707
Accounts and grants receivable, net
208
131
Prepaid expenses and other current
assets
659
1,015
Total current assets
6,680
7,853
Property and equipment, net
951
90
Deposits and other long-term assets
196
19
Intangible assets, net
2,430
2,709
TOTAL ASSETS
$
10,257
$
10,671
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
1,584
$
1,366
Related party payables, net
62
132
Deferred revenues
266
317
Right-of-use lease liability, current
portion
407
-
Insurance premium liability and other
current liabilities
310
625
Total current liabilities
2,629
2,440
Right-of-use lease liability, net of
current portion
221
-
TOTAL LIABILITIES
$
2,850
$
2,440
Commitments and contingencies
STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value,
authorized 5,000 shares; none issued and outstanding as of June 30,
2019 and December 31, 2018
-
-
Common stock, $0.0001 par value, 100,000
shares authorized; 37,630 and 35,830 shares issued and outstanding
as of June 30, 2019 and December 31, 2018, respectively
4
4
Additional paid-in capital
86,975
81,499
Accumulated other comprehensive income
(loss)
44
(2
)
Accumulated deficit
(80,276
)
(74,054
)
AgeX Therapeutics, Inc. stockholders’
equity
6,747
7,447
Noncontrolling interest
660
784
Total stockholders’ equity
7,407
8,231
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
10,257
$
10,671
AGEX THERAPEUTICS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
(UNAUDITED)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
REVENUES:
Subscription and advertising revenues
$
305
$
333
$
650
$
572
Grant revenues
47
-
62
-
Other revenues
28
131
56
131
Total revenues
380
464
768
703
Cost of sales
(53
)
(79
)
(116
)
(188
)
Gross profit
327
385
652
515
OPERATING EXPENSES:
Research and development
(1,650
)
(1,384
)
(2,988
)
(2,975
)
Acquired in-process research and
development
-
-
-
(800
)
General and administrative
(2,119
)
(1,135
)
(4,228
)
(2,425
)
Total operating expenses
(3,769
)
(2,519
)
(7,216
)
(6,200
)
Loss from operations
(3,442
)
(2,134
)
(6,564
)
(5,685
)
OTHER INCOME/(EXPENSES):
Interest income, net
33
27
45
45
Gain on sale of equity method investment
in Ascendance
-
-
-
3,215
Other income, net
257
156
229
153
Total other income, net
290
183
274
3,413
NET LOSS BEFORE INCOME TAXES
(3,152
)
(1,951
)
(6,290
)
(2,272
)
Income tax provision
(3
)
-
(76
)
-
NET LOSS
(3,155
)
(1,951
)
(6,366
)
(2,272
)
Net loss attributable to noncontrolling
interest
66
21
144
107
NET LOSS ATTRIBUTABLE TO AGEX
$
(3,089
)
$
(1,930
)
$
(6,222
)
$
(2,165
)
NET LOSS PER COMMON SHARE: BASIC AND
DILUTED
$
(0.08
)
$
(0.06
)
$
(0.17
)
$
(0.06
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING: BASIC AND DILUTED
37,630
34,225
36,891
34,004
AGEX THERAPEUTICS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Six Months Ended June
30,
2019
2018
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to AgeX
$
(6,222
)
$
(2,165
)
Net loss attributable to noncontrolling
interest
(144
)
(107
)
Adjustments to reconcile net loss
attributable to AgeX to net cash used in operating activities:
Gain on sale of equity method investment
in Ascendance
(277
)
(3,215
)
Acquired in-process research and
development
-
800
Depreciation expense
22
25
Amortization of intangible assets
279
214
Amortization of right-of-use asset
99
-
Stock-based compensation
996
312
Stock-based compensation allocated from
BioTime
-
150
Subsidiary stock-based compensation
-
4
Foreign currency remeasurement gain (loss)
and other
49
(51
)
Changes in operating assets and
liabilities:
Accounts and grants receivable, net
(77
)
(17
)
Prepaid expenses and other current
assets
359
(92
)
Accounts payable and accrued
liabilities
121
150
Related party payables
(71
)
(156
)
Insurance premium liability
(448
)
-
Deferred revenues and other current
liabilities
(63
)
(18
)
Net cash used in operating activities
(5,377
)
(4,166
)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from the sale of equity method
investment in Ascendance
277
3,215
Purchase of in-process research and
development
-
(800
)
Security deposit paid
(77
)
-
Purchase of equipment and other
(109
)
(13
)
Net cash provided by investing
activities
91
2,402
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from issuance of common
shares
-
5,000
Proceeds from exercise of warrants
4,500
-
Repayment of financing lease
liabilities
(9
)
-
Proceeds from sale of warrants
-
737
Net cash provided by financing
activities
4,491
5,737
Effect of exchange rate changes on cash
and cash equivalents
1
7
NET INCREASE (DECREASE) IN CASH, CASH
EQUIVALENTS AND RESTRICTED CASH
(794
)
3,980
CASH, CASH EQUIVALENTS AND RESTRICTED
CASH:
At beginning of the period
6,707
7,375
At end of the period
$
5,913
$
11,355
Non-GAAP Financial Measures
This press release includes operating expenses prepared in
accordance with accounting principles generally accepted in the
United States (GAAP) and, includes operating expenses, by entity,
prepared in accordance with GAAP. This press release also includes
certain historical non-GAAP operating expenses and non-GAAP
operating expenses, by entity. In particular, AgeX Therapeutics,
Inc. (“AgeX”) has provided both (a) non-GAAP total operating
expenses, adjusted to exclude noncash stock-based compensation
expense, depreciation and amortization expense, and acquired
in-process research and development expense, a nonrecurring item,
and (b) non-GAAP operating expenses, by entity, to exclude those
same charges by the respective entities for consistency. Non-GAAP
financial measures are not meant to be considered in isolation or
as a substitute for comparable financial measures prepared in
accordance with GAAP. However, AgeX believes the presentation of
non-GAAP total operating expenses and non-GAAP operating expenses,
by entity, when viewed in conjunction with our GAAP total operating
expenses, and GAAP operating expenses by entity, respectively, is
helpful in understanding AgeX’s ongoing operating expenses and its
programs and those of certain subsidiaries.
Furthermore, management uses these non-GAAP financial measures
in the aggregate and on an entity basis to establish budgets and
operational goals, to manage AgeX’s business and to evaluate its
performance and its programs in clinical development.
AGEX THERAPEUTICS, INC. AND
SUBSIDIARIES
RECONCILIATION OF NON-GAAP
FINANCIAL MEASURE
ADJUSTED OPERATING EXPENSES
For the Three Months Ended
June 30,
For the Six Months Ended June
30,
2019
(unaudited)
2018
(unaudited)
2019
(unaudited)
2018
(unaudited)
GAAP Operating Expenses - as
reported
$
3,769
$
2,519
$
7,216
$
6,200
Stock-based and other noncash compensation
expense (1)
(515)
(231)
(996)
(466)
Amortization of right-of-use assets
(1)
(99)
-
(99)
-
Depreciation and amortization expense
(1)
(152)
(117)
(301)
(239)
Acquired AgeX in-process research and
development expense (2)
-
-
-
(800)
Non-GAAP Operating Expenses, as
adjusted
$
3,003
$
2,171
$
5,820
$
4,695
GAAP Operating Expenses - by
entity
AgeX and subsidiaries other than LifeMap
Sciences (3)
$
3,176
$
1,929
$
6,036
$
5,023
LifeMap Sciences, Inc. and subsidiary
(4)
593
590
1,180
1,177
GAAP Operating Expenses - by
entity
$
3,769
$
2,519
$
7,216
$
6,200
Non-GAAP Operating Expenses - as
adjusted, by entity
AgeX and subsidiaries other than LifeMap
Sciences (3)
$
2,525
$
1,690
$
4,870
$
3,742
LifeMap Sciences, Inc. and subsidiary
(4)
478
481
950
953
Non-GAAP Operating Expenses - as adjusted,
by entity
$
3,003
$
2,171
$
5,820
$
4,695
(1)
Noncash charges
(2)
AgeX acquired and expensed certain
in-process research and development technology in March 2018,
considered to be a nonrecurring item.
(3)
AgeX Therapeutics, Inc. includes ReCyte
Therapeutics, Inc., a majority-owned and consolidated
subsidiary.
(4)
LifeMap Sciences Inc. includes LifeMap
Sciences Ltd., both consolidated subsidiaries of AgeX Therapeutics,
Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190814005751/en/
Media Contact for AgeX: Bill Douglass Gotham Communications, LLC
bill@gothamcomm.com (646) 504-0890
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