AgeX Therapeutics Reports Fourth Quarter and Annual 2020 Financial Results and Provides Business Update
AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported its financial and operating results for the fourth quarter and the full year ended December 31, 2020.
Recent Highlights
- AgeX entered into a sponsored research agreement with The Ohio State University using AgeX’s brown adipocyte tissue (BAT) cell therapy candidate AgeX-BAT1 in mice to determine whether transplantation of AgeX-BAT1 cells may improve diet-induced obesity, metabolic health including glucose metabolism, and cardiac function. Loss of non-shivering thermogenic BAT, also known as brown or good fat, in humans with aging is associated with obesity, type II diabetes, and cardiovascular disease. The research will utilize AgeX’s proprietary BAT cellular product candidate AgeX-BAT1.
- AgeX and ImStem Biotechnology, Inc. (“ImStem”), a biopharmaceutical company developing embryonic stem cell (ESC) derived mesenchymal stem cells (MSCs) entered into a non-exclusive, royalty-bearing sublicense for the use of AgeX’s clinical-grade ESC line ESI-053 to derive ImStem’s investigational MSC product candidate IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) from other causes. Emerging preclinical and clinical data support the potential of MSCs to be useful in COVID-19 and ARDS from other causes. ImStem’s MSC product candidate IMS001 is derived from AgeX’s stem cell line ESI-053. In March 2020, IMS001 gained FDA IND clearance to begin a human study in multiple sclerosis.
- AgeX announced on March 12, 2021 the online publication of data relating to regeneration, aging, and cancer in bioRxiv. The paper titled “Differential Expression of α, β, and γ Protocadherin Isoforms During Differentiation, Aging, and Cancer” presents for the first time data relating to mechanisms cells may use in the process of regeneration. The paper discloses alterations in certain genes that may prevent regeneration from occurring in adult humans. It also provides evidence that the family of genes may be involved in a wide array of human cancers.
Liquidity and Capital Resources
Amendment to 2019 Loan Agreement
On February 10, 2021, AgeX entered into an amendment to its 2019 Loan Facility Agreement with Juvenescence Limited (“Juvenescence”). The Amendment extends the maturity date of loans under the agreement to February 14, 2022 and increases the amount of the loan facility by
At-the-market Offering Facility
During January 2021 AgeX entered into a sales agreement with Chardan Capital Markets LLC (“Chardan”) for the sale of shares of AgeX common stock in at-the-market (“ATM”) transactions. In accordance with the terms of the sales agreement, AgeX may offer and sell shares of common stock having an aggregate offering price of up to
Going Concern Considerations
As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeX’s most recent projected cash flows, AgeX believes that its cash and cash equivalents and available sources of debt and equity capital would not be sufficient to satisfy AgeX’s anticipated operating and other funding requirements for the twelve months following the filing of AgeX’s Annual Report on Form 10-K for the year ended December 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.
Balance Sheet Information
Cash, and cash equivalents, and restricted cash totaled
Fourth Quarter and Annual 2020 Operating Results
Revenues: Total Revenues for the fourth quarter of 2020 were
Operating expenses: Operating expenses for the three months ended December 31, 2020, were
Operating expenses for the full year 2020 were
Research and development expenses for the year ended December 31, 2020 decreased by
General and administrative expenses for the year ended December 31, 2020 decreased by
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.
Other expense, net: Net other expense for the year ended December 31, 2020 was
Net loss attributable to AgeX: The net loss attributable to AgeX for the year ended December 31, 2020 was
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s 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. HyStem® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.
For more information, please visit www.agexinc.com or connect with the company on Twitter, LinkedIn, 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 most recent 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 |
||||||||
CONSOLIDATED BALANCE SHEETS |
||||||||
(In thousands, except par value amounts) |
||||||||
|
|
December 31, |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
527 |
|
|
$ |
2,352 |
|
Accounts and grants receivable, net |
|
|
326 |
|
|
|
363 |
|
Prepaid expenses and other current assets |
|
|
1,430 |
|
|
|
1,339 |
|
Total current assets |
|
|
2,283 |
|
|
|
4,054 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
- |
|
|
|
1,126 |
|
Deposits and other long-term assets |
|
|
50 |
|
|
|
111 |
|
Intangible assets, net |
|
|
1,592 |
|
|
|
2,151 |
|
TOTAL ASSETS |
|
$ |
3,925 |
|
|
$ |
7,442 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
1,656 |
|
|
$ |
1,582 |
|
Loan due to Juvenescence, net of debt issuance cost, current portion |
|
|
1,960 |
|
|
|
- |
|
Related party payables, net |
|
|
71 |
|
|
|
64 |
|
Deferred revenues, current portion |
|
|
275 |
|
|
|
283 |
|
Right-of-use lease liability |
|
|
- |
|
|
|
428 |
|
Paycheck Protection Program Loan |
|
|
436 |
|
|
|
- |
|
Insurance premium liability and other current liabilities |
|
|
959 |
|
|
|
940 |
|
Total current liabilities |
|
|
5,357 |
|
|
|
3,297 |
|
|
|
|
|
|
|
|
|
|
Loan due to Juvenescence, net of debt issuance cost, net of current portion |
|
|
3,900 |
|
|
|
1,528 |
|
Deferred revenues, net of current portion |
|
|
64 |
|
|
|
- |
|
TOTAL LIABILITIES |
|
|
9,321 |
|
|
|
4,825 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Preferred stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
91,810 |
|
|
|
88,353 |
|
Accumulated other comprehensive income |
|
|
143 |
|
|
|
69 |
|
Accumulated deficit |
|
|
(97,073 |
) |
|
|
(86,208 |
) |
AgeX Therapeutics, Inc. stockholders’ equity (deficit) |
|
|
(5,116 |
) |
|
|
2,218 |
|
Noncontrolling interest |
|
|
(280 |
) |
|
|
399 |
|
Total stockholders’ equity (deficit) |
|
|
(5,396 |
) |
|
|
2,617 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
|
$ |
3,925 |
|
|
$ |
7,442 |
|
AGEX THERAPEUTICS, INC. AND SUBSIDIARIES |
||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(In thousands, except per share data) |
||||||||
|
|
Year Ended December 31, |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
REVENUES: |
|
|
|
|
|
|
|
|
Subscription and advertisement revenues |
|
$ |
1,265 |
|
|
$ |
1,295 |
|
Grant revenues |
|
|
307 |
|
|
|
180 |
|
Other revenues |
|
|
296 |
|
|
|
253 |
|
Total revenues |
|
|
1,868 |
|
|
|
1,728 |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
(158 |
) |
|
|
(244 |
) |
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,710 |
|
|
|
1,484 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,978 |
|
|
|
5,904 |
|
General and administrative |
|
|
7,403 |
|
|
|
8,139 |
|
Total operating expenses |
|
|
12,381 |
|
|
|
14,043 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(10,671 |
) |
|
|
(12,559 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSES), NET: |
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
(499 |
) |
|
|
29 |
|
Other income, net |
|
|
44 |
|
|
|
294 |
|
Total other income (expense), net |
|
|
(455 |
) |
|
|
323 |
|
|
|
|
|
|
|
|
|
|
NET LOSS BEFORE INCOME TAXES |
|
|
(11,126 |
) |
AgeX Therapeutics, Inc.
NYSE:AGEAGE RankingsAGE Latest NewsAGE Stock Data
27.76M
2.45M
0.01%
Research and Development in Biotechnology
Professional, Scientific, and Technical Services
US
Alameda
About AGEagex therapeutics, inc., a biotechnology company, focuses on the development and commercialization of novel therapeutics targeting human aging and degenerative diseases in the united states. the company's lead cell-based therapeutic candidates in development include agex-bat1, a cell therapy product candidate for the treatment of various age-related metabolic disorders, such as type ii adult-onset diabetes; and agex-vasc1, a cell-based therapy to restore vascular support in aged ischemic tissues, such as the ischemic heart. its lead drug-based therapeutic candidate in discovery is agex-itr1547, a drug-based formulation to restore regenerative potential in a range of aged tissues afflicted with degenerative diseases. in addition, the company markets human embryonic stem cells; and genecards database suite, including genomic interpretation algorithms and analysis tools for use by researchers at pharmaceutical and biotechnology companies, and other institutions. agex therapeutics, inc. ha
|