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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
Financial Performance - Total revenues for the three months ended June 30, 2020, were $414,000, an increase of 8.9% compared to $380,000 for the same period in 2019[115] - Subscription and advertisement revenues for the three months ended June 30, 2020, were $298,000, up 8.4% from $275,000 in 2019[116] - Grant revenues decreased by 23.4% to $36,000 for the three months ended June 30, 2020, compared to $47,000 in 2019[116] - Total revenues for the six months ended June 30, 2020, were $929,000, a 21.0% increase from $768,000 in 2019[117] Profit and Loss - Gross profit for the three months ended June 30, 2020, was $378,000, reflecting a decrease of 15.6% from $327,000 in 2019[116] - Total research and development expenses for the six months ended June 30, 2020 amounted to $3.0 million, with general and administrative expenditures at $3.7 million, resulting in a net loss of $5.9 million[143] - The accumulated deficit as of June 30, 2020 was $92.1 million, indicating ongoing operating losses and negative cash flows since inception[138] Expenses - Operating expenses for the three months ended June 30, 2020, included a reduction in research and development expenses by $300,000 to $1.4 million[125] - General and administrative expenses decreased by 22.0% to $2.1 million for the three months ended June 30, 2020[124] - General and administrative expenses for the three months ended June 30, 2020 decreased to $1.7 million from $2.1 million in the same period in 2019, primarily due to reductions in noncash stock-based compensation and other operational costs[132] - General and administrative expenses for the six months ended June 30, 2020 were $3.726 million, down from $4.228 million in 2019[131] Cash Flow and Financing - Cash used in operating activities during the six months ended June 30, 2020 was $1.6 million, with significant adjustments for depreciation and stock-based compensation[143] - Net cash provided by financing activities during the six months ended June 30, 2020 was $3.0 million, primarily from draws against loan facilities and Paycheck Protection Program loan proceeds[144] - AgeX borrowed an additional $1.0 million under the New Loan Agreement, bringing total borrowings to $3.5 million[109] - The company borrowed a total of $3.5 million under the New Loan Agreement, with additional loans subject to discretion and approval from Juvenescence[140] Future Outlook - The company anticipates needing to raise additional capital in the near term to meet operating expenses, raising concerns about its ability to continue as a going concern[139] - The ongoing COVID-19 pandemic may adversely impact the company's financing availability and operational capabilities[141] Restructuring - The company recognized approximately $194,800 in restructuring charges related to staff reductions in May 2020[122] - Research and development expenses for the six months ended June 30, 2020, were consistent at $3.0 million compared to the same period in 2019[126] - Total research and development expenses for the year 2020 were $2.953 million, slightly down from $2.988 million in 2019[1]
AgeX Therapeutics(AGE) - 2020 Q1 - Quarterly Report
2020-05-14 20:16
Revenue and Profit - Total revenues for the three months ended March 31, 2020, increased by 32.7% to $515,000 compared to $388,000 for the same period in 2019 [110]. - Subscription and advertisement revenues decreased by 2.0% to $338,000 in Q1 2020 from $345,000 in Q1 2019 [111]. - Grant revenues increased significantly to $86,000 in Q1 2020 from $15,000 in Q1 2019, reflecting a growth of 473.3% [112]. - Gross profit for the three months ended March 31, 2020, was $481,000, up 48.0% from $325,000 in the same period of 2019 [111]. Expenses - Research and development expenses rose by 19.8% to $1.6 million in Q1 2020 from $1.3 million in Q1 2019 [117]. - General and administrative expenses remained stable at $2.1 million for both Q1 2020 and Q1 2019, despite increased costs from leasing and staffing [122]. - Total research and development expenses for the three months ended March 31, 2020, were $1.6 million, while general and administrative expenditures were $2.1 million, resulting in a net loss of $3.2 million for the same period [133]. Operating Loss and Cash Flow - As of March 31, 2020, the company had an accumulated deficit of $89.4 million and expects to continue incurring operating losses and negative cash flows [129]. - Net cash used in operating activities during the three months ended March 31, 2020, amounted to $2.1 million, with a difference attributed to non-cash items including $0.5 million in working capital changes and $0.4 million in depreciation and amortization [133]. Future Outlook and Funding - Operating expenses are expected to decrease in future periods due to staff reductions and budget adjustments [115]. - The company anticipates recognizing approximately $194,800 in restructuring charges related to staffing reductions in Q2 2020 [115]. - The company borrowed an initial $500,000 under the New Loan Agreement, but additional loans are subject to Juvenescence's discretion, raising concerns about future funding availability [131]. - The company does not have any committed sources of funds for additional financing, raising substantial doubt about its ability to continue as a going concern [130]. Financing Activities - Net cash provided by financing activities for the three months ended March 31, 2020, amounted to $0.2 million, attributed to the draw of the remaining $0.2 million from a previous loan facility [134]. - The New Loan Agreement requires the company to issue shares and warrants to Juvenescence, which could dilute existing stockholders' equity interests [132]. Investment Activities - Cash used in investing activities during the three months ended March 31, 2020, was $4,000, entirely for laboratory equipment purchases [134]. Legal Matters - The company has not been involved in any material litigation or proceedings as of the reporting date [138].