- Ends 2018 with triad of innovative cell
therapy technologies: UniverCyte™ for immune tolerance, PureStem®
for cell derivation and manufacturing, and HyStem® for cell
delivery
- Potential to generate any human cell
type with clinical and commercial friendly characteristics of
hypoimmunogenicity, low COGS and availability off-the-shelf
- Juvenescence increased ownership
by paying BioTime, Inc. $43.2M to become largest shareholder
- Became public company with common stock
traded on the NYSE American under ticker “AGE”
- Board and management strengthened with
seasoned professionals in financing, R&D and cell
therapies
- Secured almost $10M from sale of a
non-core asset, equity financing and NIH Grant
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company focused on developing and commercializing
innovative cellular and regenerative therapeutics for diseases of
old age, reported financial and operating results for the fourth
quarter and year ended December 31, 2018.
“2018 has been a transformative year for AgeX. We became a
public company, listed on the NYSE American, and made progress
toward becoming a leader in the cell therapy and longevity
sectors,” said Michael D. West, Ph.D., Chief Executive Officer.
“One highlight was that we acquired an immune tolerance technology,
UniverCyte™, with the potential to produce hypoimmunogenic cells
for new therapies. Considering the number of high-profile
publications and deals in this space, we would expect this platform
to hold us in good stead for both our current product development
programs and the potential for third party collaborations. We think
this technology could help us deliver nearer and longer term value
to our stockholders.”
“AgeX has both exciting cell- and iTR™-based platforms. Using
UniverCyte™ in combination with our pluripotent stem cell-based
PureStem® cell derivation and manufacturing technology, we aim to
generate universal, off-the-shelf cells for therapeutic products
with reduced COGS,” said Greg Bailey, M.D., Chairman of the AgeX
Board of Directors. “Our goal is to overcome key industry barriers
to successful development and commercialization of cellular
therapies, including immune rejection, high manufacturing costs,
and a service-based business model.”
Additional Recent Highlights
- Secured $5M strategic investment from
Juvenescence in June 2018.
- Received approximately $3.2M from the
sale of Ascendance Biotechnology, a non-core asset.
- Received $4.5M from the exercise of
warrants in March 2019.
- Secured $386,000 in non-dilutive
funding in the form of a grant award from the National Institutes
of Health.
- Made progress in moving our preclinical
cellular and iTR™ programs forward, as reflected in part by our
papers published in peer-reviewed scientific journals: Stem Cell
Research & Therapy, related to our brown adipose tissue cell
therapy program AGEX-BAT1 for metabolic disorders such as Type II
Diabetes and obesity, and Oncotarget, identifying genes implicated
in tissue regeneration and cancer, in support of our iTR™
program
- Appointed seasoned biotech investor
Gregory Bailey, M.D., as Chairman of the Board. Dr. Bailey is the
CEO of Juvenescence, AgeX’s largest shareholder, and was an initial
financier and board member of Medivation, Inc. which went public
and later was acquired by Pfizer for $14.3Bn.
- Appointed experienced life science
thought leader, Dr. Annalisa Jenkins, to the Board. Dr. Jenkins
previously served as President and CEO of Dimension Therapeutics, a
leading gene therapy company, and had prior global R&D
leadership roles at Merck Serono and Bristol Myers-Squibb.
- Appointed John F. Mauldin to the Board,
a well-known financial writer, publisher, and New York Times
best-selling author. Mr. Mauldin appears regularly on CNBC, Yahoo
Tech Ticker, and Bloomberg TV. Mr. Mauldin serves as Chairman of
Mauldin Economics, an investment newsletter and information
publishing firm.
- Appointed Dr. Nafees Malik, a
specialist in the strategy, execution and commercialization of cell
therapies as Chief Operating Officer. Dr. Malik also serves as the
Head of Cellular Therapy at Juvenescence. His prior roles have
spanned clinical medicine, healthcare investment banking and
biopharmaceutical companies.
Balance Sheet Highlights
Cash and cash equivalents totaled $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.
Fourth Quarter and Annual 2018 Operating Results
Revenues: Total Revenues for the fourth quarter of 2018 were
$0.3 million as compared to $0.5 million in the comparable quarter
in 2017. Total revenues for the year ended 2018 were $1.4 million,
relatively unchanged as compared to 2017. AgeX revenues were
primarily generated by its subsidiary LifeMap Sciences, Inc. as
subscription and advertising revenues from its GeneCards® online
database.
Operating expenses: Operating expenses for the three months
ended December 31, 2018, were $3.5 million, as reported, which was
comprised of $2.9 million for AgeX and $0.6 million for LifeMap
Sciences, and were $2.5 million, as adjusted, comprised of $2.0
million for AgeX and $0.5 million for LifeMap Sciences.
Operating expenses for 2018 were $12.3 million, as reported,
which was comprised of $10.0 million for AgeX and $2.3 million for
LifeMap Sciences, and were $9.5 million, as adjusted, comprised of
$7.6 million for AgeX and $1.9 million for LifeMap Sciences.
The reconciliation between GAAP and non-GAAP operating expenses
is provided in the financial tables included with this earnings
release.
R&D Expenses: R&D expenses for the year ended December
31, 2018 were $6.6 million, compared to $5.8 million for 2017. The
increase was mainly attributable to an increase in our R&D
spending in our PureStem progenitor cell lines, brown adipose fat,
iTR technology programs and a nonrecurring expense of $800,000 to
acquire certain in-process R&D.
G&A Expenses: General and administrative expenses for the
three months ended December 31, 2018 increased by $1.3 million to
$2.0 million as compared to $0.7 million in 2017. General and
administrative expenses for the year ended December 31, 2018
increased by $1.7 million to $5.6 million as compared to $3.9
million in 2017. The increases were mainly attributable to
financial reporting, compliance, legal and other expenses incurred
in becoming a public company, and increase in non-cash stock-based
compensation expense due to increased stock option grants.
Other Income, net: We received approximately $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 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)
December 31, 2018 2017
ASSETS CURRENT ASSETS Cash and cash equivalents $ 6,707 $
7,375 Accounts and grants receivable, net 131 107 Prepaid expenses
and other current assets 1,015 111 Total current
assets 7,853 7,593 Equipment and furniture, net 90 129
Deposits and other long-term assets 19 35 Intangible assets, net
2,709 1,874 TOTAL ASSETS $ 10,671 $ 9,631
LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES
Accounts payable and accrued liabilities $ 1,416 $ 768 Related
party payables to BioTime and Juvenescence 82 210 Deferred revenues
317 180 Other current liabilities 625 154 TOTAL
LIABILITIES 2,440 1,312
Commitments and contingencies
STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value,
authorized 5,000 shares; none issued and outstanding as of December
31, 2018 and 2017
- - Common shares, $0.0001 par value, 100,000 shares authorized;
35,830 and 33,750 shares issued and outstanding as of December 31,
2018 and 2017, respectively 4 3 Additional paid-in capital 81,499
73,761 Accumulated other comprehensive income (loss) (2 ) 68
Accumulated deficit (74,054 ) (66,552 ) AgeX
Therapeutics, Inc. stockholders’ equity 7,447 7,280 Noncontrolling
interest 784 1,039 Total stockholders’ equity
8,231 8,319 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $
10,671 $ 9,631
AGEX THERAPEUTICS, INC. AND
SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED) Three Months
Ended Year Ended December 31, December 31,
2018 2017 2018 2017 REVENUES:
Subscription and advertisement revenues $ 282 $ 455 $ 1,227 $ 1,399
Service and other revenues 11 3 149 5 Grant revenues 20
- 20 - Total
revenues 313 458 1,396 1,404 Cost of sales (180 ) (54 ) (364
) (168 ) Gross profit 133
404 1,032 1,236
OPERATING EXPENSES: Research and development (1,523 ) (1,267
) (5,830 ) (5,784 ) Acquired in-proces research and development - -
(800 ) - General and administrative (1,968 ) (695 )
(5,647 ) (3,869 ) Total operating expenses
(3,491 ) (1,962 ) (12,277 ) (9,653 ) Gain on
sale of assets - - -
1,754 Loss from operations (3,358 )
(1,558 ) (11,245 ) (6,663 )
OTHER
INCOME/(EXPENSES): Interest income (expense), net 32 16 116 (12
) Gain on sale of equity method investment in Ascendance - - 3,215
- Other income (expense), net 52 (2 )
183 38 Total other income, net 84
14 3,514 26
NET LOSS (3,274 ) (1,544 ) (7,731 ) (6,637 ) Net loss
attributable to noncontrolling interest 88 37
229 57
NET LOSS
ATTRIBUTABLE TO AGEX $ (3,186 ) $ (1,507 ) $ (7,502 ) $ (6,580
) NET LOSS PER COMMON SHARE: BASIC AND DILUTED $ (0.09 ) $
(0.04 ) $ (0.21 ) $ (0.21 ) WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING: BASIC AND DILUTED 35,830
33,750 34,914 30,644
AGEX THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(IN THOUSANDS)
Year Ended December 31, 2018
2017 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss
attributable to AgeX $ (7,502 ) $ (6,580 ) Net loss attributable to
noncontrolling interest (229 ) (57 ) 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 58 165 Amortization of intangible assets 477
517 Amortization of deferred license fees - 17 Gain on sale of
assets - (1,754 ) Stock-based compensation 1,285 114 Stock-based
compensation allocated from BioTime 184 411 Subsidiary stock-based
compensation 4 227 Bad debt expense - (121 ) Foreign currency
remeasurement (gain) and other (68 ) - Changes in operating assets
and liabilities: Accounts receivable and other receivables (24 )
322 Prepaid expenses and other current assets (293 ) 10 Accounts
payable and accrued liabilities 648 267 Related party payable to
BioTime (128 ) - Deferred revenues 137 (84 ) Other (129 )
261 Net cash used in operating activities (7,995 )
(6,285 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from the sale of equity method investment in Ascendance
3,215 - Purchase of in-process research and development (1,872 ) -
Purchase of equipment and other assets (21 ) (1 ) Removal of cash
upon deconsolidation of LifeMap Solutions - (3 ) Security deposit
received and other, net 5 9 Net cash provided by
investing activities 1,327 5
CASH FLOWS
FROM FINANCING ACTIVITIES: Contributions from BioTime - 1,971
Advances from BioTime - 1,304 Proceeds from sale of common shares
5,000 10,000 Proceeds from sale of warrants 1,000 -
Net cash provided by financing activities 6,000
13,275 Effect of exchange rate changes on cash and cash
equivalents - 121
NET INCREASE (DECREASE)
IN CASH AND CASH EQUIVALENTS (668 ) 7,116
CASH AND CASH
EQUIVALENTS: Beginning of year 7,375 259 End of
year $ 6,707 $ 7,375
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
For the Three Months
EndedDecember 31,2018 (unaudited)
For the Year EndedDecember 31,
2018
GAAP Operating Expenses - as reported $ 3,491
$ 12,277 Stock-based compensation expense (1)
(797 ) (1,473 ) Depreciation and amortization expense (1) (150 )
(535 ) Acquired in-process research and development expense (2)
- (800 ) Non-GAAP Operating Expenses,
as adjusted $ 2,544 $ 9,469
GAAP
Operating Expenses - by entity AgeX and subsidiaries other than
LifeMap Sciences (3) $ 2,897 $ 9,946 LifeMap Sciences, Inc. and
subsidiary (4) 594 2,331
GAAP
Operating Expenses - by entity $ 3,491
$ 12,277 Non-GAAP Operating
Expenses - as adjusted, by entity AgeX and subsidiaries other than
LifeMap Sciences $ 2,066 $ 7,589 LifeMap Sciences, Inc. and
subsidiary 478 1,880 Non-GAAP
Operating Expenses - as adjusted, by entity $ 2,544 $
9,469 (1) Noncash charges (2) AgeX acquired
certain in-process research and development 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/20190401005894/en/
Media Contact for AgeX:Bill DouglassGotham Communications,
LLCbill@gothamcomm.com(646) 504-0890
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