AgeX Therapeutics(AGE)
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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 ...
AgeX Therapeutics(AGE) - 2020 Q2 - Quarterly Report
2020-08-14 20:16
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 June 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 othe ...
AgeX Therapeutics(AGE) - 2020 Q1 - Quarterly Report
2020-05-14 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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 ...