Serina Therapeutics, Inc.(SER)

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Serina Therapeutics, Inc.(SER) - 2024 Q2 - Quarterly Results
2024-08-09 20:25
Exhibit 99.1 Serina Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Highlights HUNTSVILLE, August 9, 2024 (GLOBE NEWSWIRE) — Serina Therapeutics ("Serina") (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug delivery technology, today reported financial results for the quarter ended June 30, 2024 and provided business highlights. Recent Highlights ● Partnership with Enable Injections. The Company will develop and commerc ...
Serina Therapeutics, Inc.(SER) - 2024 Q2 - Quarterly Report
2024-08-09 20:20
Financial Performance - Revenues for the three and six months ended June 30, 2024, were not material[204]. - The net loss attributable to Serina for the six months ended June 30, 2024, was $9.8 million, with non-cash items contributing to the difference between net loss and cash used in operating activities[225]. - Other income increased to $9.04 million for Q2 2024, compared to $1.75 million in Q2 2023, primarily due to a $9.3 million gain from the fair value of liability classified Merger Warrants[210]. - For the six months ended June 30, 2024, other expense netted $3.7 million, a change of $8 million from $4.4 million income in the same period in 2023, largely due to a $7 million loss in fair value of Legacy Serina Convertible Notes[211]. Research and Development Expenses - Research and development expenses for Q2 2024 were $1.6 million, a 232.8% increase from $0.5 million in Q2 2023[203]. - For the first half of 2024, research and development expenses totaled $2.7 million, up 207.5% from $0.9 million in the same period of 2023[204]. - The increase in research and development expenses was primarily due to a non-recurring $0.3 million severance expense and increases in salaries and consulting services[205]. - The company expects research and development expenses to increase substantially as it continues to invest in product candidate development and clinical trials[194]. - The company anticipates that research and development expenses will continue to increase as it seeks to advance its product candidates[220]. General and Administrative Expenses - General and administrative expenses for Q2 2024 reached $2.3 million, a 391.1% increase compared to $0.5 million in Q2 2023[203]. - In the first half of 2024, general and administrative expenses were $3.5 million, reflecting a 232.4% increase from $1.1 million in the same period of 2023[204]. - General and administrative expenses increased mainly due to $0.6 million in professional legal and accounting services related to a merger completed on March 26, 2024[208]. - The company anticipates that general and administrative expenses will rise over the next several years to support ongoing research and development and compliance as a public company[200]. Cash Flow and Financing - As of June 30, 2024, the company had $6.1 million in cash and cash equivalents, with $2.9 million drawn from the 2022 Secured Note and $4.99 million received from Juvenescence through Post-Merger Warrants[215]. - The net cash used in operating activities for the six months ended June 30, 2024, was $9.6 million, a significant increase of 509.4% from $1.57 million in the same period in 2023[224]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $8.1 million, primarily from the exercise of Post-Merger Warrants and credit facilities[227]. - The company expects to incur substantial expenditures for product development and will require additional financing to continue operations beyond 2025[221]. Internal Controls and Compliance - The company identified material weaknesses in internal controls over financial reporting, including insufficient qualified accounting staff and reliance on manual reporting processes[232]. - A remediation plan has been initiated to address these weaknesses, involving the engagement of financial operations consultants and the appointment of a new Controller for Legacy Serina[235]. - The company believes that its quarterly report fairly presents its financial condition and results of operations, despite the identified weaknesses[230]. - There were no changes in internal control over financial reporting that materially affected its effectiveness during the reporting period[237]. - The company is committed to ongoing monitoring and enhancement of internal controls as necessary, but acknowledges inherent limitations in their effectiveness[237]. - The material weaknesses will not be remediated until the remediation plan is fully developed and tested for effectiveness[236]. - The company has implemented direct management oversight and the use of legal and accounting professionals to mitigate identified weaknesses[233]. - The company is focused on ensuring the reliability of its financial reporting processes moving forward[230]. Legal Matters - A putative shareholder class action lawsuit was filed against the company related to the Merger Agreement, but was dismissed on March 5, 2024[240]. - The company continues to face potential litigation matters that could materially affect future results of operations and financial position[239].
Serina Therapeutics, Inc.(SER) - 2024 Q1 - Quarterly Results
2024-05-14 20:25
[Business Highlights](index=1&type=section&id=Recent%20Highlights) In Q1 2024, Serina Therapeutics advanced its lead drug candidate SER-252 for Parkinson's Disease, with plans for a Phase 1 trial in 2025. The company completed a merger with AgeX Therapeutics, resulting in a new NYSE American listing under the ticker "SER". Additionally, Dr. Simba Gill was appointed as Executive Chairman to guide strategic growth - The company is advancing its lead drug candidate, **SER-252** (POZ-apomorphine), for advanced Parkinson's Disease and anticipates submitting an IND application to the FDA to start a Phase 1 clinical trial in **2025**[1](index=1&type=chunk) - Completed a merger with AgeX Therapeutics and began trading on the NYSE American market under the ticker "**SER**" on March 27, 2024[2](index=2&type=chunk) - Appointed Dr. Simba Gill as Executive Chairman to leverage his biotech and pharma experience to guide the company's growth and strategic expansion[3](index=3&type=chunk) [Liquidity and Capital Resources](index=1&type=section&id=Liquidity%20and%20Capital%20Resources) Serina increased its secured line of credit from Juvenescence Limited by a total of $2.925 million across March and May 2024, extending the repayment date to December 31, 2024. As of March 31, 2024, the company held $8.8 million in cash, cash equivalents, and restricted cash, while owing $10.4 million in principal and fees to Juvenescence - The company's line of credit from Juvenescence Limited was increased by **$2.4 million** on March 26, 2024, and by an additional **$0.525 million** on May 8, 2024[4](index=4&type=chunk) - The repayment date for the Juvenescence line of credit was extended from May 9, 2024, to **December 31, 2024**[4](index=4&type=chunk) Key Liquidity Figures (as of March 31, 2024) | Metric | Amount | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $8.8 million | | Debt to Juvenescence Limited (principal & fees) | $10.4 million | [First Quarter 2024 Operating Results](index=1&type=section&id=First%20Quarter%202024%20Operating%20Results) For Q1 2024, Serina reported a net loss of $9.4 million, a stark contrast to the $1.7 million net income in Q1 2023. This was driven by operating expenses more than doubling to $2.3 million, due to increased R&D and merger-related G&A costs. A significant $7 million non-cash expense from the change in fair value of convertible promissory notes also heavily impacted the bottom line Q1 2024 vs Q1 2023 Financial Performance (amounts in thousands or millions as specified, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Grant Revenues | $5,000 | $30,000 | | Operating Expenses | $2.3 million | $1.0 million | | Net Income (Loss) | ($9.4 million) | $1.7 million | | EPS (Basic & Diluted) | ($3.38) | $0.77 (Basic), $0.20 (Diluted) | - Research and development expenses increased by **$0.7 million** to **$1.1 million**, while general and administrative expenses rose by **$0.6 million** to **$1.2 million**, largely due to professional services for the merger[8](index=8&type=chunk)[9](index=9&type=chunk) - Net loss was primarily impacted by a **$7.0 million** charge related to the change in fair value of convertible promissory notes, which were converted to common stock on March 26, 2024[10](index=10&type=chunk) [Going Concern Considerations](index=2&type=section&id=Going%20Concern%20Considerations) The company's management has determined that its current cash reserves and recent borrowings are insufficient to fund operations for the next twelve months. This situation raises substantial doubt about Serina's ability to continue as a going concern - Based on projected cash flows, the company believes its cash, cash equivalents, and recent borrowings are not sufficient to satisfy anticipated operating requirements for the next **twelve months**[12](index=12&type=chunk) - These factors raise **substantial doubt** regarding the ability of the Company to continue as a **going concern**[12](index=12&type=chunk) [Technology and Pipeline](index=2&type=section&id=Technology%20and%20Pipeline) Serina's core technology is the POZ Platform™, which uses a synthetic polymer to enhance drug delivery. Its lead candidate, SER-252, leverages this platform for an apomorphine-based therapy for Parkinson's disease, aiming for continuous stimulation with reduced side effects, with clinical trials planned for 2025. The company also pursues partnerships, including a licensing agreement with Pfizer for LNP drug delivery - The lead candidate, **SER-252**, is an investigational therapy for Parkinson's disease designed to provide continuous dopaminergic stimulation (CDS) and is planned to advance to clinical testing in **2025**[13](index=13&type=chunk) - The proprietary **POZ technology** is engineered to offer greater control in drug loading and precision in release rates for subcutaneously injected drugs, aiming to improve therapies with narrow therapeutic windows[14](index=14&type=chunk) - Serina intends to advance its **POZ platform** through partnerships, highlighted by a non-exclusive license agreement with **Pfizer, Inc.** for use in lipid nanoparticle (LNP) drug delivery formulations[15](index=15&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section provides the company's consolidated financial statements, including balance sheets and statements of operations, reflecting its financial position and performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=SERINA%20THERAPEUTICS%2C%20INC.%20AND%20SUBSIDIARIES%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2024, Serina's total assets were $10.9 million, while total liabilities stood at $15.2 million, resulting in a stockholders' deficit of $4.3 million. The balance sheet reflects significant changes from year-end 2023, primarily due to the merger and related financing, including a large increase in current liabilities from loans and the conversion of preferred stock Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,706 | $7,619 | | Total current assets | $8,937 | $7,619 | | **Total Assets** | **$10,856** | **$8,968** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $14,059 | $1,413 | | **Total Liabilities** | **$15,165** | **$4,858** | | Total stockholders' deficit | ($4,309) | ($32,294) | | **Total Liabilities & Stockholders' Deficit** | **$10,856** | **$8,968** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=SERINA%20THERAPEUTICS%2C%20INC.%20AND%20SUBSIDIARIES%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the first quarter of 2024, Serina reported a net loss of $9.4 million, or ($3.38) per share. This compares to a net income of $1.7 million, or $0.77 per basic share, for the same period in 2023. The significant loss was driven by a higher loss from operations and a $7.0 million non-cash expense from the change in fair value of convertible promissory notes Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total revenues | $5 | $30 | | Loss from operations | ($2,321) | ($962) | | Change in fair value of convertible promissory notes | ($7,017) | $294 | | **Net Income (Loss)** | **($9,437)** | **$1,658** | | **Net Earnings (Loss) Per Share - Basic** | **($3.38)** | **$0.77** | | **Net Earnings (Loss) Per Share - Diluted** | **($3.38)** | **$0.20** |
Serina Therapeutics, Inc.(SER) - 2024 Q1 - Quarterly Report
2024-05-14 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered Common Stock, par value $0.0001 per share SER NYSE American FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission ...
Serina Therapeutics, Inc.(SER) - 2023 Q4 - Annual Report
2024-03-22 21:27
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, 2023 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 j ...
Serina Therapeutics, Inc.(SER) - 2023 Q3 - Quarterly Report
2023-11-14 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered Common Stock, par value $0.0001 per share AGE NYSE American 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commissi ...
Serina Therapeutics, Inc.(SER) - 2023 Q2 - Quarterly Report
2023-08-14 20:16
Revenue and Expenses - AgeX recognized revenues of $9,000 and $19,000 for the three and six months ended June 30, 2023, respectively, compared to $12,000 and $17,000 for the same periods in 2022, indicating a revenue decrease of approximately 25% for the three-month period [166]. - Cost of sales for the three and six months ended June 30, 2023, were $5,000 and $6,000, respectively, down from $6,000 and $7,000 in the same periods of 2022, reflecting a decrease of 16.67% for the three-month period [167]. - Research and development expenses decreased by approximately $0.1 million to $0.16 million for the three months ended June 30, 2023, a 38.2% decrease compared to $0.26 million in 2022 [169]. - General and administrative expenses increased by $0.4 million to $1.7 million for the three months ended June 30, 2023, a 29.3% increase compared to $1.3 million in 2022 [171]. - Total other expense, net for the three months ended June 30, 2023, was $1 million, primarily due to amortization of deferred debt issuance costs [175]. Financial Position and Cash Flow - AgeX incurred an accumulated deficit of $122.2 million as of June 30, 2023, and expects to continue incurring operating losses and negative cash flows [181]. - Net cash used in operating activities for the six months ended June 30, 2023, was $3.9 million, with a net loss attributable to the company of $6 million [190]. - Cash flows from investing activities included a $10 million loan made to Serina during the six months ended June 30, 2023 [191]. - Financing activities provided net cash of $13.5 million, entirely from credit facilities drawn from Juvenescence during the same period [192]. - The difference between net loss and cash used in operating activities was primarily due to non-cash items totaling $2.1 million [190]. - The company may need to modify or suspend operations if financing is unavailable or inadequate [188]. Strategic Initiatives - AgeX is pursuing a potential merger with Serina, which has not yet been finalized or approved by either company's board of directors [160][161]. - The company plans a potential spinoff of its subsidiary Reverse Bio, which would become a separate publicly traded company if completed [160]. - The company has made adjustments to its operating plans to reduce projected cash expenditures, including downsizing its leased office space and workforce [182]. - Operating expenses were reduced by outsourcing research and development, but this has hindered progress in developing target product candidates and technologies [186]. Operational Challenges - The company faced uncertainty regarding the impact of the COVID-19 pandemic on financing availability and overall operations [187]. - The ongoing pandemic's impact on business results remains highly uncertain and difficult to predict [187]. - There were no changes in internal control over financial reporting that materially affected the company's controls [194]. - The company is not currently involved in any material litigation or proceedings [196].
Serina Therapeutics, Inc.(SER) - 2023 Q1 - Quarterly Report
2023-05-12 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of exchange on which registered Common Stock, par value $0.0001 per share AGE NYSE American FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission ...
Serina Therapeutics, Inc.(SER) - 2022 Q4 - Annual Report
2023-03-31 20:16
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, 2022 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 j ...
Serina Therapeutics, Inc.(SER) - 2022 Q2 - Quarterly Report
2022-08-12 20:16
Financial Performance - Total revenues for the three months ended June 30, 2022, were $12,000, a decrease of 67.6% compared to $37,000 for the same period in 2021[22]. - Net loss attributable to AgeX for the six months ended June 30, 2022, was $5,324,000, compared to a net loss of $4,562,000 for the same period in 2021, representing an increase of 16.7%[22]. - The company reported a gross profit of $6,000 for the three months ended June 30, 2022, compared to $24,000 for the same period in 2021, a decline of 75%[22]. - AgeX recognized a gain of $106,000 from the deconsolidation of LifeMap Sciences, which is reported as a taxable transaction resulting in a taxable loss[92]. - The accumulated deficit as of June 30, 2022 was $111.1 million, indicating ongoing operating losses and negative cash flows since inception[185]. Cash and Liquidity - Cash and cash equivalents increased to $702,000 as of June 30, 2022, from $584,000 as of December 31, 2021, reflecting a growth of 20.2%[20]. - AgeX's cash and cash equivalents were $0.7 million as of June 30, 2022, which, along with a potential additional loan of $3.0 million, may not be sufficient to meet its funding requirements for the next twelve months[38]. - AgeX's total cash, cash equivalents, and restricted cash amounted to $752,000 as of June 30, 2022, compared to $634,000 as of December 31, 2021[56]. - Net cash used in operating activities from continuing operations for the six months ended June 30, 2022, was $3,382,000, compared to $4,234,000 for the same period in 2021, a decrease of 20.1%[28]. - The company expects to continue incurring operating losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern[186]. Expenses - Research and development expenses for the three months ended June 30, 2022, were $259,000, a decrease of 46.1% from $481,000 for the same period in 2021[22]. - General and administrative expenses for the six months ended June 30, 2022, were $2,998,000, down 20.5% from $3,770,000 for the same period in 2021[22]. - AgeX incurred approximately $11,000 and $57,000 of allowable expenses under the NIH grant for the three and six months ended June 30, 2021, respectively[68]. - Total other expense, net for the six months ended June 30, 2022 was $1.7 million, consisting of $1.4 million amortization of deferred debt issuance costs and $0.3 million unrealized loss on warrants[179]. - For the six months ended June 30, 2022, stock-based compensation expense totaled $437,000, compared to $464,000 for the same period in 2021[141]. Debt and Financing - AgeX had drawn the full $8.0 million line of credit under the 2020 Loan Agreement, with the outstanding principal balance due on March 30, 2023[98]. - AgeX has drawn $10,160,000 from a $13,160,000 line of credit under the Secured Convertible Promissory Note, with an outstanding principal balance due on February 14, 2024[101]. - The company may sell up to $12.1 million of additional shares of common stock in "at-the-market" transactions to raise capital[188]. - AgeX's total debt balances net of issuance costs amounted to $18.63 million, with debt issuance costs totaling $7.92 million[120]. - The company faces challenges in obtaining necessary capital due to ongoing net operating losses and debt obligations to Juvenescence[203]. Stock and Equity - The weighted average number of common shares outstanding for the three months ended June 30, 2022, was 37,943,000, compared to 37,936,000 for the same period in 2021[22]. - As of June 30, 2022, AgeX had 37,945,108 shares of common stock issued and outstanding, an increase from 37,941,220 shares at December 31, 2021[132]. - AgeX issued warrants to purchase 6,502,442 shares of common stock in connection with $10,160,000 of drawdowns from Juvenescence under the Secured Note during the six months ended June 30, 2022[133]. - AgeX's stockholders' equity was reported to be less than $2,000,000, leading to a deficiency letter from the NYSE American regarding continued listing standards[156]. - AgeX regained compliance with the NYSE American's continued listing standards on April 15, 2021, but remains subject to normal continued listing monitoring[157]. Operational Changes - The company has initiated staff reductions and eliminated laboratory facilities to reduce operating expenses amid the COVID-19 pandemic[39]. - The company has deferred in-house development of its product candidates and technologies due to staffing reductions and the closing of research laboratory facilities[203]. - AgeX's operations and financial results may be impacted by the ongoing COVID-19 pandemic, with uncertainty regarding the duration and scope of its effects[167]. - The ongoing COVID-19 pandemic may adversely impact the availability of financing and disrupt operations, adding to the uncertainty of future capital needs[190]. - The company is exploring options for obtaining additional capital, including the sale of common stock and collaborative research arrangements[203]. Research and Development - AgeX plans to finance its iTR research and development through its subsidiary Reverse Bioengineering, Inc.[46]. - AgeX's research and development expenses consist primarily of personnel costs, stock-based compensation, and outside consultants[72]. - Research and development expenses for the six months ended June 30, 2022 were $0.7 million, reflecting a focus on outsourcing rather than internal development[192]. - The company has a Sponsored Research Agreement with the University of California at Irvine for the derivation of neural stem cells, with initial work expected to conclude during 2022[166]. - AgeX does not expect to earn subscription and advertising revenues in subsequent accounting periods due to the LifeMap Deconsolidation[65].