AgeX Therapeutics(AGE)
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AgeX Therapeutics(AGE) - 2022 Q4 - Annual Report
2023-03-30 16:00
Part I [Business](index=9&type=section&id=Item%201.%20Business) AgeX Therapeutics develops therapeutics for human aging and degenerative diseases, leveraging core technologies like PureStem® and pursuing corporate restructuring - The company aims to develop and commercialize novel therapeutics for human aging and degenerative diseases, leveraging expertise in cellular immortality and regenerative biology[47](index=47&type=chunk) - Core technology platforms include **PureStem®** for cell therapies, **UniverCyte™** for hypoimmunogenic cells, **HyStem®** for cell delivery, and **iTR** for reversing cellular aging[48](index=48&type=chunk)[76](index=76&type=chunk)[79](index=79&type=chunk) - Key discovery-stage product candidates include **AGEX-BAT1** for metabolic disorders, **AGEX-VASC1** for ischemic diseases, and **AGEX-iTR1547/1550** for scarless tissue regeneration[71](index=71&type=chunk)[72](index=72&type=chunk) - Due to limited financial resources, AgeX eliminated in-house R&D, shifting to outsourcing, licensing, and sponsored research agreements[14](index=14&type=chunk)[84](index=84&type=chunk)[239](index=239&type=chunk) - The company is pursuing significant corporate restructuring, including a potential merger with Serina Therapeutics and a spinoff of its iTR-focused subsidiary, Reverse Bioengineering Inc[11](index=11&type=chunk)[59](index=59&type=chunk)[61](index=61&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including a 'going concern' warning, heavy reliance on Juvenescence, and significant operational and regulatory challenges - **Financial Condition:** The company has a history of operating losses, an accumulated deficit of **$116.2 million** as of year-end 2022, and its ability to continue as a 'going concern' is in substantial doubt, highly dependent on additional financing, primarily from Juvenescence[6](index=6&type=chunk)[203](index=203&type=chunk)[207](index=207&type=chunk) - **Relationship with Juvenescence:** Juvenescence owns a significant percentage of common stock, is a major creditor, and can substantially influence corporate matters, creating potential conflicts of interest and potentially making AgeX a 'controlled company' if loans are converted[9](index=9&type=chunk)[222](index=222&type=chunk)[225](index=225&type=chunk) - **Planned Restructuring:** Significant uncertainties and risks are associated with the potential merger with Serina Therapeutics and the planned spinoff of the Reverse Bio subsidiary, with no assurance of consummation and potential dilution to existing stockholders[11](index=11&type=chunk)[227](index=227&type=chunk)[236](index=236&type=chunk) - **Business Operations:** AgeX has reduced staffing, eliminated research labs, and has no in-house R&D capabilities, with no product candidates tested in clinical trials and preclinical success not indicative of future results[14](index=14&type=chunk)[239](index=239&type=chunk)[242](index=242&type=chunk) - **Industry and Regulatory Risks:** The company faces significant competition from better-funded companies, a lengthy, costly, and unpredictable FDA approval process, especially for novel cell and gene therapies, and potential restrictive regulations due to ethical and social concerns about stem cell use[20](index=20&type=chunk)[297](index=297&type=chunk)[300](index=300&type=chunk) - **Dependence on Third Parties:** AgeX is dependent on future collaborations for product development, clinical trials, manufacturing, and commercialization, lacking internal resources for these activities[27](index=27&type=chunk)[372](index=372&type=chunk)[382](index=382&type=chunk) [Unresolved Staff Comments](index=75&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments - Not Applicable[428](index=428&type=chunk) [Properties](index=75&type=section&id=Item%202.%20Properties) The company leases a small office space of 101 square feet in Alameda, California, with a monthly rent of $844 - The company's principal office is a **101 square foot** leased space in Alameda, CA, with the lease beginning January 1, 2023, at a monthly rent of **$844**[429](index=429&type=chunk) [Legal Proceedings](index=75&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings - The company is not presently involved in any material litigation or proceedings[430](index=430&type=chunk) [Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[430](index=430&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=77&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) AgeX common stock trades on NYSE American, with details on record holders and equity compensation plan information - The company's common stock has traded on the NYSE American under the symbol **"AGE"** since November 29, 2018[431](index=431&type=chunk) - As of March 20, 2023, there were **232** holders of record of the common stock[431](index=431&type=chunk) Equity Compensation Plan Information as of December 31, 2022 | Plan Category | Number of Shares to be Issued upon Exercise (thousands) | Weighted Average Exercise Price | Number of Shares Remaining Available for Future Issuance (thousands) | | :--- | :--- | :--- | :--- | | AgeX Stock Option Plans Approved by Stockholders | 3,264 | $2.25 | 5,139 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=77&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management expresses substantial doubt about the company's going concern ability due to significant losses and negative cash flows - The company has incurred significant operating losses since inception, with an accumulated deficit of **$116.2 million** as of December 31, 2022, and management expects losses to continue[437](index=437&type=chunk) - A going concern assessment raises substantial doubt about the company's ability to operate for at least one year from the report's issuance date, given its current cash and available financing[441](index=441&type=chunk)[496](index=496&type=chunk) Comparison of Results of Operations (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$34** | **$144** | **($110)** | **-76.4%** | | Research and development | $1,025 | $1,456 | ($431) | -29.6% | | General and administrative | $5,971 | $6,708 | ($737) | -11.0% | | **Total operating expenses** | **$6,996** | **$8,164** | **($1,168)** | **-14.3%** | | **Net Loss from Continuing Operations** | **($10,522)** | **($8,582)** | **($1,940)** | **22.6%** | - The decrease in revenue was primarily due to the completion of an NIH grant in 2021, while the decrease in operating expenses reflects reduced scientific consulting, outside research, and compensation costs following 2020 staff reductions[482](index=482&type=chunk)[486](index=486&type=chunk)[487](index=487&type=chunk) Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,939) | ($7,765) | | Net cash provided by investing activities | $0 | $716 | | Net cash provided by financing activities | $6,000 | $7,496 | [Financial Statements and Supplementary Data](index=89&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements show significant losses and accumulated deficit, with the auditor expressing substantial doubt about going concern - The auditor's report contains a paragraph highlighting substantial doubt about the Company's ability to continue as a going concern due to recurring losses, negative cash flows, and insufficient cash to fund operations for the next twelve months[510](index=510&type=chunk) Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $645 | $584 | | Total Assets | $3,241 | $3,154 | | Total Liabilities | $20,556 | $15,029 | | Accumulated Deficit | ($116,210) | ($105,748) | | Total Stockholders' Deficit | ($17,315) | ($11,875) | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Total Revenues | $34 | $144 | | Total Operating Expenses | $6,996 | $8,164 | | Net Loss | ($10,522) | ($8,685) | | Net Loss Per Share | ($0.28) | ($0.23) | - As of December 31, 2022, the company had federal net operating loss carryforwards of approximately **$52.8 million** and state NOLs of **$14.9 million**, which are subject to a full valuation allowance[491](index=491&type=chunk)[492](index=492&type=chunk)[683](index=683&type=chunk) - The company received a deficiency letter from the NYSE American in November 2021 for failing to meet continued listing standards, but submitted a compliance plan and was granted an extension until May 17, 2023, to regain compliance[704](index=704&type=chunk) - Subsequent to year-end, in early 2023, the company amended its secured note with Juvenescence to borrow up to an additional **$2.0 million**, extended the maturity of its 2020 loan, and entered into a new **$10 million** secured note with Juvenescence to fund a loan to Serina Therapeutics in contemplation of a potential merger[706](index=706&type=chunk)[710](index=710&type=chunk) [Controls and Procedures](index=139&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[726](index=726&type=chunk) - Management assessed internal control over financial reporting as effective as of December 31, 2022, based on the 2013 COSO framework[729](index=729&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=140&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) The report details the Board of Directors and executive officers, highlighting the close ties and influence of major shareholder Juvenescence - The Board of Directors as of March 20, 2023, includes Gregory H. Bailey, M.D., Joanne M. Hackett, Ph.D., and Michael H. May, Ph.D[730](index=730&type=chunk) - Key executive officers include Michael D. West, Ph.D. (CEO), Andrea E. Park (CFO), and Nafees N. Malik (COO), with Dr. Bailey as Executive Chairman of Juvenescence and Dr. Malik as a Juvenescence employee, highlighting close ties[730](index=730&type=chunk)[736](index=736&type=chunk)[738](index=738&type=chunk) - The company has an Audit Committee chaired by Michael H. May, who is considered an "audit committee financial expert"[734](index=734&type=chunk) - The company has adopted a Code of Business Conduct and Ethics applicable to all officers and directors[735](index=735&type=chunk) [Executive Compensation](index=143&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2022 is detailed, including CEO, CFO, and COO salaries, with no stock or option awards granted 2022 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Michael D. West, CEO | 2022 | 546,782 | 0 | 15,250 | 562,032 | | Andrea E. Park, CFO | 2022 | 281,228 | 0 | 14,061 | 295,289 | | Nafees N. Malik, COO | 2022 | 282,272 (1) | 0 | 0 | 282,272 | - Note (1): Dr. Malik's compensation represents consulting fees paid to Juvenescence for his services[746](index=746&type=chunk)[747](index=747&type=chunk) - Employment agreements for the CEO and CFO provide for severance benefits, including salary continuation and accelerated vesting of equity awards, if terminated without "cause" or if they resign for "good reason," with enhanced benefits following a "Change of Control"[755](index=755&type=chunk)[756](index=756&type=chunk) - The company's 2017 Equity Incentive Plan allows for the granting of stock options, restricted stock, SARs, and RSUs, with **5,139,000** shares remaining available for grant as of December 31, 2022[659](index=659&type=chunk)[672](index=672&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=152&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Juvenescence Limited and its affiliates are the largest beneficial owner, holding approximately **78.7%** of the company's common stock Security Ownership of Major Holders (as of March 20, 2023) | Name of Beneficial Owner | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :--- | :--- | :--- | | Juvenescence Limited and certain affiliates | 79,425,155 | 78.7% | | Broadwood Partners, L.P. and certain affiliates | 3,003,446 | 7.9% | | All executive officers and directors as a group (7 persons) | 2,512,436 | 6.2% | - Juvenescence's beneficial ownership includes **16,447,500** shares held directly, **13,271,230** shares issuable via warrants, and **49,706,335** shares issuable upon conversion of outstanding debt[795](index=795&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=154&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has extensive financial relationships with Juvenescence, its largest shareholder, including multiple secured loan agreements - AgeX is heavily reliant on financing from its largest shareholder, Juvenescence, through several loan agreements, with total borrowings from Juvenescence at **$32,160,000** as of March 20, 2023[210](index=210&type=chunk)[497](index=497&type=chunk) - Key loan facilities include the **$8.0 million** 2020 Loan Agreement, the **$15.16 million** 2022 Secured Note (of which **$14.16 million** was drawn as of March 20, 2023), and a new **$10 million** Secured Note executed in March 2023[625](index=625&type=chunk)[629](index=629&type=chunk)[815](index=815&type=chunk) - The loans from Juvenescence are secured by a lien on substantially all of AgeX's assets, including its intellectual property and shares in subsidiaries, with default potentially leading to foreclosure and loss of all assets[638](index=638&type=chunk)[821](index=821&type=chunk) - In connection with the loans, AgeX has issued and will issue a substantial number of common stock purchase warrants to Juvenescence, further increasing Juvenescence's potential ownership stake[627](index=627&type=chunk)[812](index=812&type=chunk) - In March 2023, AgeX used proceeds from the **$10 million** Secured Note from Juvenescence to lend **$10 million** to Serina Therapeutics, in contemplation of a potential merger between AgeX and Serina[815](index=815&type=chunk)[717](index=717&type=chunk) - Three directors are deemed independent (Hackett, May, Bailey), but Dr. Bailey's independence is noted as not meeting Audit Committee standards under Rule 10A-3 due to his role as Executive Chairman of Juvenescence[827](index=827&type=chunk)[828](index=828&type=chunk) [Principal Accounting Fees and Services](index=163&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Total fees paid to independent accounting firms were **$411,000** in 2022 and **$357,000** in 2021, with all services pre-approved Accountant Fees (in thousands) | Fee Category | 2022 | 2021 | | :--- | :--- | :--- | | Audit Fees | $358 | $303 | | Audit-Related Fees | $53 | $54 | | **Total Fees** | **$411** | **$357** | - **100%** of the fees paid to the auditors in 2022 and 2021 were pre-approved by the Audit Committee[832](index=832&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=164&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits, including loan agreements with Juvenescence and unaudited financials for Reverse Bioengineering Inc - The filing includes a list of exhibits, such as the Asset Purchase Agreement with Escape Therapeutics, various loan and warrant agreements with Juvenescence, and the company's 2017 Equity Incentive Plan[835](index=835&type=chunk) - Unaudited financial statements are provided for the subsidiary Reverse Bioengineering, Inc., whose securities are pledged as collateral for debt owed to Juvenescence[844](index=844&type=chunk) Reverse Bioengineering, Inc. Financial Highlights (Unaudited, in thousands) | | 2022 | 2021 | | :--- | :--- | :--- | | **Balance Sheet** | | | | Total Liabilities | $936 | $388 | | Total Stockholders' Deficit | ($936) | ($388) | | **Statement of Operations** | | | | Net Loss | ($548) | ($262) | [Form 10-K Summary](index=170&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company states there is no Form 10-K summary provided - None[849](index=849&type=chunk)
AgeX Therapeutics(AGE) - 2021 Q4 - Annual Report
2022-03-28 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-38519 AgeX Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1436829 (State or other ju ...
AgeX Therapeutics(AGE) - 2020 Q4 - Annual Report
2021-03-30 16:00
Company Overview - AgeX is focused on developing therapeutics targeting human aging and degenerative diseases, with a mission to address age-associated medical conditions as demand rises due to demographic shifts[12]. - AgeX was incorporated in 2017 and has undergone significant changes in ownership, with Lineage Cell Therapeutics initially owning 85.4% of shares, which decreased to 4.8% after a distribution of shares[18][20]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[26]. Technology and Product Pipeline - The company owns or has licenses to multiple patents related to its proprietary technology, including PureStem technology and UniverCyte™, aimed at producing cell-based therapies[13]. - AgeX's product pipeline includes two cell-based therapies (AGEX-BAT1 and AGEX-VASC1) and two iTR-based candidates (AGEX-iTR1547 and AGEX-iTR1550), all in the discovery stage[32][33]. - AgeX's technology platforms reflect over 25 years of research in cell immortality and regenerative medicine, targeting large unmet needs in age-related diseases[31]. - The company has expanded its technology platforms by acquiring patents related to HLA-G-modified cells, which are foundational for the UniverCyte™ technology[20]. - AgeX has developed the PureStem technology platform, which allows for the generation of allogeneic cell therapies that can be commercialized as "off-the-shelf" products, offering lower costs and higher clinical adoption potential[36]. - Induced Tissue Regeneration (iTR) technology seeks to revert aged cells to a youthful state, potentially enabling scarless regeneration and addressing age-related degenerative diseases[40]. - The company has isolated over 200 cell types from PureStem, which are expected to provide permanent engraftment in the body, unlike mesenchymal stem cells (MSCs) that have limited survival[37]. Clinical Development and Collaborations - The company is negotiating a merger with LyGenesis, which has received FDA clearance for a Phase 2a clinical trial, potentially enhancing AgeX's capabilities in organ regeneration[21][22]. - AgeX has six clinical-grade human embryonic stem cell lines, with ESI-053 being the first pluripotent stem cell line to receive FDA IND clearance for human studies related to multiple sclerosis[42]. - The company plans to pursue co-development and licensing opportunities for its technologies, aiming to generate early revenue streams from partnerships with other biopharma companies[43]. - A collaboration with the University of California at Irvine aims to derive neural stem cells for treating neurological disorders, with initial focus on Huntington's disease[81]. - The company has entered a Sponsored Research Agreement with Ohio State University to test AGEX-BAT1 in mice for improvements in metabolic health[71]. Financial Performance and Capital Needs - The company incurred operating losses of $10.7 million and $12.6 million for the years ended December 31, 2020, and 2019, respectively, with an accumulated deficit of approximately $97.1 million as of December 31, 2020[153]. - The company anticipates continued losses and will need to raise capital to finance operations, with no assurance of achieving profitability[153]. - The company has substantial doubt about its ability to continue as a going concern due to insufficient cash and cash equivalents to meet anticipated operating requirements for the next twelve months[156]. - The company has a credit line of $8.0 million under the 2020 Loan Agreement, of which $7.5 million has been borrowed, with additional borrowing subject to Juvenescence's discretion[159]. - The company may need to issue additional common stock purchase warrants to Juvenescence, which could dilute existing stockholders' interests[163]. Regulatory and Market Challenges - The FDA has not granted marketing approval to any pluripotent stem-based therapeutic products, indicating potential regulatory challenges for the company's product candidates[124]. - The biotechnology industry is highly competitive, with numerous companies developing therapeutics for human aging, which may impact the company's market position and product acceptance[115]. - The company faces competition from established treatments for Type II diabetes, including various pharmacological interventions and lifestyle changes, which may affect market penetration[117]. - The company must obtain approval from foreign regulatory authorities before commencing clinical trials or marketing products in those regions, which may vary in time and requirements compared to FDA approval[126]. - The ongoing pandemic's impact on operations and financial results remains uncertain, with potential alterations to business strategies being monitored[203]. Operational Risks and Compliance - The company recognizes the potential risks associated with relying on third-party arrangements for research, development, and commercialization of its product candidates[46]. - The company must navigate various federal and state fraud and abuse laws, including anti-kickback laws and false claims laws, which could result in significant penalties[138]. - The company is dependent on key technologies licensed from Lineage, and failure to meet obligations under these agreements could result in loss of rights[190]. - The company must ensure effective internal controls to prevent fraud and maintain accurate financial reporting, as failures could have material adverse effects[199]. - Compliance with anti-bribery laws is costly and complex, particularly in countries with high corruption levels, impacting operational costs[204]. Staffing and Organizational Structure - The company employs 6 full-time and 5 part-time employees, with a focus on scientific expertise[151]. - As of December 31, 2020, the company had only 11 employees, which may hinder its ability to attract and retain qualified personnel for future growth[172]. - The company has reduced staffing and eliminated in-house research and development, focusing on outsourcing or licensing product development[165].
AgeX Therapeutics(AGE) - 2020 Q3 - Quarterly Report
2020-11-16 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-38519 AgeX Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1436829 (State or ...