AgeX Therapeutics(AGE)

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DiagnaMed Expands with Drug and Clinical Research AI Platform
GlobeNewswire News Room· 2024-08-21 12:00
BRAIN AGE® Brain Health AI Platform - DiagnaMed Holdings Corp is expanding the use of its BRAIN AGE® Brain Health AI Platform by leveraging EEG data from research studies and future data collection to build a potential drug discovery and clinical research AI platform [1] - BRAIN AGE® estimates brain age by recording brain-wave activity from multiple brain regions and calculating the data with a proprietary machine-learning model [2] - The platform can assess if a brain is aging more quickly or slowly than typical for healthy individuals and can evaluate brain health by scoring brain resilience, vulnerability, and performance functions [2] - BRAIN AGE® has the potential to accelerate patient recruitment for clinical trials, data analysis, drug development decisions, and new treatment options for neurological, psychiatric, and infectious diseases [1] Clinical Applications and Validation - BRAIN AGE® can classify and identify drugs according to their mechanism of action on brain activity, which is useful for developing novel drug analogs and potential drug repurposing ideas [2] - The platform can be used as an inexpensive way to screen large numbers of people for vulnerability to age-related cognitive decline and to test the effectiveness of medications and lifestyle changes [3] - A peer-reviewed paper in Frontiers in Neuroergonomics highlights the effectiveness of BRAIN AGE® for large-scale screening and brain optimization using a low-cost EEG headset [3] Company Overview - DiagnaMed Holdings Corp is a healthcare technology company focused on brain health using AI, commercializing the BRAIN AGE® Brain Health AI Platform, which estimates brain age and provides a brain health score [4] - The company is leveraging its proprietary EEG data to accelerate clinical trial development and discover potential novel treatments for neurological, psychiatric, and infectious diseases [1]
AgeX Therapeutics(AGE) - 2024 Q2 - Quarterly Results
2024-08-09 20:25
[Business Highlights](index=1&type=section&id=Business%20Highlights) The company reported a debt extension, a strategic partnership, positive technology data, and a key leadership addition - The repayment date for borrowings under the Juvenescence Secured Note was extended to December 31, 2024, and the line of credit was increased by an additional **$525,000**[3](index=3&type=chunk) - Entered a partnership with Enable Injections to develop and commercialize **SER-252** for Parkinson's disease, with plans to initiate a **Phase 1 trial in 2025**[5](index=5&type=chunk) - Presented data showing its proprietary **POZ-lipid technology does not induce an IgM or IgG antibody response**, unlike PEG-lipids used in current mRNA vaccines[5](index=5&type=chunk) - Appointed **Dr. Srini Tenjarla**, formerly of Takeda and Shire, as Senior Vice President of CMC & Formulation[5](index=5&type=chunk) Liquidity Position as of June 30, 2024 | Metric | Amount (USD) | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $6.1 million | | Principal and fees owed to Juvenescence Limited | $11.2 million | [Financial Results](index=2&type=section&id=Financial%20Results) The company reported Q2 net income of $5.2 million due to non-cash gains, despite rising operating expenses and a going concern warning [Second Quarter Operating Results](index=2&type=section&id=Second%20Quarter%20Operating%20Results) Q2 2024 net income of $5.2 million was driven by a $9.3 million non-cash gain, offsetting a significant rise in operating expenses Q2 2024 vs. Q2 2023 Financial Highlights (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Revenues | $51 | $7 | | Operating Expenses | $3,917 | $952 | | Net Income Attributable to Serina | $5,204 | $808 | | Basic EPS | $0.61 | $0.37 | | Diluted EPS | $0.51 | $0.11 | - **Research and development (R&D) expenses increased by $1.1 million** to $1.6 million YoY, primarily due to severance, increased salaries, and consulting services[7](index=7&type=chunk) - **General and administrative (G&A) expenses rose by $1.8 million** to $2.3 million YoY, mainly from merger-related legal and accounting fees[8](index=8&type=chunk) - Net other income for Q2 2024 was $9.0 million, primarily comprised of a **$9.3 million non-cash gain** from the change in fair value of derivative warrant liabilities[9](index=9&type=chunk) [Going Concern Considerations](index=2&type=section&id=Going%20Concern%20Considerations) Management expressed substantial doubt about the company's ability to continue as a going concern due to insufficient cash reserves - Management has concluded that there is **substantial doubt** regarding the Company's ability to continue as a going concern[11](index=11&type=chunk) - The company's cash and cash equivalents of **$6.1 million** as of June 30, 2024, are not expected to be sufficient to fund operations for the next twelve months[11](index=11&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows total assets of $10.7 million, total liabilities of $27.1 million, and a stockholders' deficit of $16.4 million Balance Sheet Summary (in thousands) | Account | June 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,064 | $7,619 | | Total Current Assets | $8,917 | $7,619 | | **Total Assets** | **$10,708** | **$8,968** | | Total Current Liabilities | $12,633 | $1,413 | | **Total Liabilities** | **$27,101** | **$4,858** | | **Total Stockholders' Deficit** | **($16,393)** | **($32,294)** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a Q2 net income of $5.2 million but a six-month net loss of $9.8 million, reflecting high operating expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total Revenues | $51 | $56 | | Total Operating Expenses | $3,917 | $6,243 | | Loss from Operations | ($3,866) | ($6,187) | | Total Other Income (Expense), Net | $9,043 | ($3,651) | | **Net Income (Loss) Attributable to Serina** | **$5,204** | **($9,811)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $9.6 million for the six-month period, with the cash balance decreasing by $1.5 million to $6.1 million Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,586) | ($1,573) | | Net cash used in investing activities | ($14) | ($315) | | Net cash provided by financing activities | $8,095 | $10,078 | | **Net Change in Cash** | **($1,505)** | **$8,190** | | **Cash at end of period** | **$6,114** | **$8,722** | [Pipeline and Technology](index=2&type=section&id=Pipeline%20and%20Technology) The company is advancing its pipeline, led by SER-252, by leveraging its proprietary POZ Platform™ drug delivery technology [SER-252 (POZ-apomorphine)](index=2&type=section&id=SER-252%20(POZ-apomorphine)) SER-252 is an investigational therapy for Parkinson's disease designed to provide continuous stimulation with a planned clinical start in 2025 - **SER-252** is an investigational apomorphine therapy designed to provide **continuous dopaminergic stimulation (CDS)** to reduce motor complications in Parkinson's disease[12](index=12&type=chunk) - Preclinical studies indicate SER-252 has the potential to provide CDS **without causing skin reactions**[12](index=12&type=chunk) - Serina plans to advance SER-252 to **clinical testing in 2025**[12](index=12&type=chunk) [POZ Platform™](index=3&type=section&id=POZ%20Platform%E2%84%A2) The POZ Platform™ is a proprietary polymer technology designed to improve drug delivery by enabling precise control over release rates - The POZ technology uses a synthetic, water-soluble, low-viscosity polymer to achieve **greater control in drug loading and release**[13](index=13&type=chunk) - It is designed to improve drugs with narrow therapeutic windows by **maintaining more stable blood levels** and addressing limitations like toxicity[13](index=13&type=chunk) - The platform is being advanced through partnerships, including a non-exclusive license with **Pfizer, Inc.** for use in lipid nanoparticle (LNP) drug delivery[14](index=14&type=chunk) [Corporate Overview and Forward-Looking Statements](index=3&type=section&id=Corporate%20Overview%20and%20Forward-Looking%20Statements) Serina is a clinical-stage biotech company focused on neurological diseases, and its report contains forward-looking statements with inherent risks - Serina is a clinical-stage biotechnology company developing a pipeline of drug candidates to treat **neurological diseases and pain**[15](index=15&type=chunk) - The company's POZ Platform is also being utilized by partners to advance **lipid nanoparticle (LNP) delivery technology** for novel RNA therapeutics[15](index=15&type=chunk) - The report contains **forward-looking statements** that are subject to substantial risks and uncertainties related to drug development and regulatory approvals[17](index=17&type=chunk)
AgeX Therapeutics(AGE) - 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, indicating a focus on development rather than immediate revenue generation [229]. - The company incurred a net loss of $9.8 million for the six months ended June 30, 2024, with non-cash items affecting cash flow [251]. - The company had an accumulated deficit of $23.2 million as of June 30, 2024, indicating ongoing financial challenges [243]. - 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 $1.573 million in the same period in 2023 [250]. - Other income, net for the three months ended June 30, 2024, was $9.04 million, compared to $1.75 million in the same period in 2023, reflecting a change of $7.3 million [235]. Research and Development Expenses - Research and development expenses increased to $1.6 million for Q2 2024, up 232.8% from $0.5 million in Q2 2023, primarily due to severance and payroll-related expenses [227]. - For the six months ended June 30, 2024, research and development expenses totaled $2.7 million, reflecting a 207.5% increase from $0.9 million in the same period of 2023 [228]. - The company anticipates a substantial increase in research and development expenses as it continues to invest in clinical trials and product development [217]. - The company expects to continue incurring losses and will require additional financing to support ongoing operations and product development [246]. - The company anticipates that its research and development expenses will continue to increase, necessitating further capital raising efforts [248]. General and Administrative Expenses - General and administrative expenses rose to $2.3 million for Q2 2024, a 391.1% increase from $0.5 million in Q2 2023, driven by legal and accounting services related to the recent merger [227]. - General and administrative expenses for the six months ended June 30, 2024, were $3.5 million, a 232.4% increase from $1.1 million in the same period of 2023 [228]. - The increase in general and administrative expenses is also attributed to costs associated with being a public company, including compliance and investor relations [224]. - General and administrative expenses increased to $3.5 million for the six months ended June 30, 2024, from $1.1 million in the same period in 2023, a rise of 218.2% [234]. - A non-recurring severance expense of $0.3 million contributed to the increase in both research and development and general administrative expenses [230][233]. Cash and Financing Activities - Cash and cash equivalents stood at $6.1 million as of June 30, 2024, with additional expected proceeds of $9.975 million from the exercise of Post-Merger Warrants [241]. - 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 [253]. - The fair value of liability classified Merger Warrants resulted in a gain of $3.7 million during the six months ended June 30, 2024, compared to nil in the same period in 2023 [237]. - The company is expanding its workforce and infrastructure to support ongoing research and development efforts [223]. - The company expects to face significant costs and uncertainties in obtaining regulatory approvals for its product candidates [218].
AgeX Therapeutics(AGE) - 2024 Q1 - Quarterly Results
2024-05-14 20:25
Exhibit 99.1 Serina Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Highlights HUNTSVILLE, May 14, 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 March 31, 2024 and provided business highlights. Recent Highlights Liquidity and Capital Resources Increase in Line of Credit On March 26, 2024 ...
AgeX Therapeutics(AGE) - 2024 Q1 - Quarterly Report
2024-05-14 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 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 file number 1-38519 Serina Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction o ...
AgeX Therapeutics(AGE) - 2023 Q4 - Annual Results
2024-03-22 21:28
Liquidity and Capital Resources Issuance of Preferred Stock to Eliminate $36 Million of Indebtedness and Conversion to Common Stock During July 2023, AgeX and Juvenescence Limited entered into an Exchange Agreement pursuant to which AgeX issued shares of Series A Preferred Stock and Series B Preferred Stock to Juvenescence in exchange for the extinguishment of a total of $36 million of indebtedness under a loan agreement and certain promissory notes. The Series A Preferred Stock and Series B Preferred Stock ...
AgeX Therapeutics(AGE) - 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 ...
AgeX Therapeutics Reports Fourth Quarter and Annual 2023 Financial Results
Newsfilter· 2024-03-22 21:27
ALAMEDA, Calif., March 22, 2024 (GLOBE NEWSWIRE) -- AgeX Therapeutics, Inc. (("AgeX", NYSE:AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported its financial and operating results for fourth quarter and the full year ended December 31, 2023 and recent highlights. Recent Highlights ●Stockholders approved transactions for merger with Serina Therapeutics, Inc. ●Obtained $4.4 million addition to line of credit from Juvenescence Limited ●Preferred Stock converted into ...
AgeX Therapeutics(AGE) - 2023 Q3 - Quarterly Report
2023-11-13 16:00
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, 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) (State or other jurisdiction o ...
AgeX Therapeutics(AGE) - 2023 Q2 - Quarterly Report
2023-08-13 16:00
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, 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) (State or other jurisdiction of inc ...