- Published data in peer-reviewed
scientific journal to advance potential cell therapy AgeX-BAT1 for
Type II Diabetes and obesity
- Received $4.5 million from the exercise
of warrants in March 2019
- Presented at four industry and investor
conferences
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company focused on therapeutics for human aging,
reported financial and operating results for the first quarter
ended March 31, 2019.
“We are building AgeX into what we believe will be a leading
company focused on extending human healthspan, and we continued to
make solid progress toward that goal in the first quarter of the
year,” said Michael D. West, Ph.D., founder and Chief Executive
Officer. “Among other accomplishments, we published data in the
peer-reviewed journal Stem Cell Research & Therapy relating to
our product in development for Type II diabetes designated
AgeX-BAT1. Our paper disclosed data on the purity and identity of
the product manufactured using our proprietary PureStem®
technology. In addition, our presentation of induced Tissue
Regeneration (iTRTM) technology in meetings around the world is
generating excitement in the aging research community as a novel
strategy to not only restore functionality to aged tissues, but
also to reverse molecular markers of aging.”
Additional Recent Highlights
- Dr. West participated at four industry
and investor conferences during the quarter. These included
presentations at the Emerging Therapeutics Showcase at Precision
Medicine World Congress (PMWC), January 20-23 in Silicon Valley, in
a session chaired by MIT’s Feng Zhang; the Longevity Leaders
Conference, February 4 in London, England; Undoing Aging, March
28-30 in Berlin, Germany; Master Investor Show, April 6, in London,
England.
- AgeX’s subsidiary LifeMap Sciences
announced that Tianjin Novogene Medical Laboratory and Shanghai
Shanyi have become distributors of LifeMap Sciences genomics
technology software products in China.
- AgeX received $4.5
million from the exercise of AgeX common stock warrants.
Warrant holders purchased a total of 1,800,000 shares of AgeX
common stock through the exercise of warrants.
- Signed sublease for an office and
research facility where AgeX will construct a modern, cGMP
compliant, laboratory facility for the manufacture of cell lines
and its cell-based product candidates.
Balance Sheet Highlights
Cash and cash equivalents totaled $8.6 million as of March 31,
2019, as compared with $6.7 million as of December 31, 2018. AgeX
strengthened its balance sheet by $4.5 million in proceeds from
warrant exercises in March 2019.
First Quarter 2019 Operating Results
Revenues: Total Revenues for the first quarter of 2019 were
$388,000, as compared with $239,000 for the first quarter of 2018.
AgeX revenues are primarily generated by its subsidiary LifeMap
Sciences, Inc. as subscription and advertising revenues from its
GeneCards® online database.
Operating expenses: Operating expenses reported for the three
months ended March 31, 2019 were $3.4 million as compared to $3.7
million for the same period in 2018. On an as-adjusted basis,
operating expenses for the three months ended March 31, 2019 were
$2.8 million as compared to $2.5 million for the same period in
2018.
The reconciliation between GAAP and non-GAAP operating expenses
is provided in the financial tables included with this earnings
release.
Research and development expenses and acquired in-process
research and development (“IPR&D”) decreased by $1.1 million to
$1.3 million during the three months ended March 31, 2019 from $2.4
million during the same period in 2018. The decrease was primarily
attributable to a decrease of $0.3 million for programs utilizing
PureStem® cell lines and iTR technology and also the non-recurrence
of in-process research and development expense that was incurred
during March 2018 in connection with the purchase of certain assets
primarily related to stem cell derived cardiomyocytes (heart muscle
cells) to be developed by us.
General and administrative expenses for the three months ended
March 31, 2019 increased by $0.8 million to $2.1 million as
compared to $1.3 million during the same period in 2018. This
increase was primarily attributable to the following increases in
expenses: a $0.3 million of noncash stock-based compensation
expense; $0.2 million in insurance premiums; $0.1 million in
consulting, travel and related expenses; $0.1 million in legal and
accounting expenses; and $0.1 million in patent and license filing
and maintenance related expenses.
Other Income, net: Other income in the first quarter of 2018 was
$3.2 million compared to an insignificant amount in the current
quarter. We received $3.2 million and recognized a gain on sale of
our ownership interest in Ascendance Biotechnology, Inc. when that
company was acquired by a third party 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 other reports 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) March 31, 2019 December
31, 2018 (Unaudited) ASSETS CURRENT ASSETS
Cash and cash equivalents $ 8,586 $ 6,707 Accounts and grants
receivable, net 206 131 Prepaid expenses and other current assets
856 1,015 Total current assets 9,648
7,853 Equipment and furniture, net 84 90 Deposits and other
long-term assets 19 19 Intangible assets, net 2,570
2,709 TOTAL ASSETS $ 12,321 $ 10,671
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT
LIABILITIES Accounts payable and accrued liabilities $ 1,316 $
1,366 Related party payables, net 140 132 Deferred revenues 361 317
Other current liabilities 477 625 TOTAL
LIABILITIES 2,294 2,440
Commitments and contingencies STOCKHOLDERS’ EQUITY Preferred
stock, $0.0001 par value, authorized 5,000 shares; none issued and
outstanding as of March 31, 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 March 31, 2019 and
December 31, 2018, respectively 4 4 Additional paid-in capital
86,480 81,499 Accumulated other comprehensive income (loss) 24 (2 )
Accumulated deficit (77,187 ) (74,054 ) AgeX
Therapeutics, Inc. stockholders’ equity 9,321 7,447 Noncontrolling
interest 706 784 Total stockholders’
equity 10,027 8,231 TOTAL LIABILITIES
AND STOCKHOLDERS’ EQUITY $ 12,321 $ 10,671
AGEX
THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE
DATA) (UNAUDITED) Three Months Ended
March 31, 2019 2018
REVENUES: Subscription and advertising revenues $ 345 $ 239
Grant and other revenues 43 - Total
revenues 388 239 Cost of sales (63 ) (109 )
Gross profit 325 130
OPERATING EXPENSES: Research and development (1,338 ) (1,591
) Acquired in-process research and development - (800 ) General and
administrative (2,109 ) (1,290 ) Total operating
expenses (3,447 ) (3,681 ) Loss from operations
(3,122 ) (3,551 )
OTHER
INCOME/(EXPENSES): Interest income, net 12 18 Gain on sale of
equity method investment in Ascendance - 3,215 Other expense, net
(28 ) (3 ) Total other income (expense), net
(16 ) 3,230
NET LOSS BEFORE INCOME
TAXES (3,138 ) (321 ) Income tax provision (73 )
-
NET LOSS (3,211 ) (321 ) Net loss
attributable to noncontrolling interest 78 86
NET LOSS ATTRIBUTABLE TO AGEX $ (3,133 ) $
(235 ) NET LOSS PER COMMON SHARE: BASIC AND DILUTED $ (0.09
) $ (0.01 ) WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC AND DILUTED 36,143 33,750
AGEX
THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (IN THOUSANDS)
(UNAUDITED) Three Months Ended
March 31, 2019 2018 CASH FLOWS FROM
OPERATING ACTIVITIES: Net loss attributable to AgeX $ (3,133 )
$ (235 ) Net loss attributable to noncontrolling interest (78 ) (86
) Adjustments to reconcile net loss attributable to AgeX to net
cash used in operating activities: Gain on sale of equity method
investment in Ascendance - (3,215 ) Acquired in-process research
and development - 800 Depreciation expense 10 15 Amortization of
intangible assets 139 107 Stock-based compensation 481 145
Stock-based compensation allocated from BioTime - 88 Subsidiary
stock-based compensation - 2 Income tax provision 73 - Foreign
currency remeasurement loss and other 29 - Changes in operating
assets and liabilities: Accounts and grants receivable, net (75 )
53 Prepaid expenses and other current assets (64 ) (29 ) Accounts
payable and accrued liabilities (52 ) 282 Related party payables 8
(150 ) Deferred revenues 44 150 Other current liabilities -
68 Net cash used in operating activities
(2,618 ) (2,005 )
CASH FLOWS FROM INVESTING
ACTIVITIES: Proceeds from the sale of equity method investment
in Ascendance - 3,215 Purchase of in-process research and
development - (800 ) Purchase of equipment and other (3 )
(1 ) Net cash (used in) provided by investing activities
(3 ) 2,414
CASH FLOWS FROM FINANCING
ACTIVITIES: Proceeds from exercise of warrants 4,500 - Proceeds
from sale of warrants - 737 Net cash
provided by financing activities 4,500 737
Effect of exchange rate changes on cash and cash
equivalents - (1 )
NET INCREASE IN
CASH AND CASH EQUIVALENTS 1,879 1,145
CASH AND CASH
EQUIVALENTS: At beginning of the period 6,707
7,375 At end of the period $ 8,586 $ 8,520
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
Amounts In Thousands and Unaudited
For the Three Months Ended March 31, 2019
2018 GAAP Operating Expenses - as reported $
3,447 $ 3,681 Stock-based compensation
expense (1) (481 ) (235 ) Depreciation and amortization expense (1)
(149 ) (122 ) Acquired in-process research and development expense
(2) - (800 ) Non-GAAP Operating
Expenses, as adjusted $ 2,817 $ 2,524
GAAP Operating Expenses - by entity AgeX and subsidiaries
other than LifeMap Sciences (3) $ 2,860 $ 3,094 LifeMap Sciences,
Inc. and subsidiary (4) 587 587
GAAP Operating Expenses - by entity $ 3,447
$ 3,681 Non-GAAP
Operating Expenses - as adjusted, by entity AgeX and subsidiaries
other than LifeMap Sciences $ 2,345 $ 2,052 LifeMap Sciences, Inc.
and subsidiary 472 472 Non-GAAP
Operating Expenses - as adjusted, by entity $ 2,817 $
2,524 (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/20190515005942/en/
Media Contact for AgeX:Bill DouglassGotham Communications,
LLCbill@gothamcomm.com(646) 504-0890
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