AgeX Therapeutics(AGE) - 2025 Q2 - Quarterly Results

Executive Summary Q2 2025 Financial Results and Business Highlights Overview Serina Therapeutics announced its financial results for the second quarter ended June 30, 2025, along with key recent business updates, highlighting the advancement of its lead IND candidate, SER-252, and SER-270, both enabled by its proprietary POZ Platform™ - SER-252 is on track to enter the clinic later this year for advanced Parkinson's disease[2] - SER-270 for tardive dyskinesia recently advanced, demonstrating the POZ Platform's capability for differentiated, long-acting therapies[2] CEO Statement CEO Steve Ledger expressed pride in the development momentum, emphasizing the POZ Platform's potential to unlock best-in-class treatment profiles and improve patient outcomes in neurological conditions with high unmet needs, beyond what existing drug delivery approaches can achieve - CEO highlights strong momentum across development programs, with SER-252 and SER-270 advancing[2] - Believes the proprietary polymer technology (POZ Platform) can enable differentiated, long-acting therapies and improve patient outcomes[2] Business Highlights Pipeline Advancement Serina announced the advancement of SER-270 for tardive dyskinesia in July 2025 and secured funding to support the continued development of SER-252, its lead clinical candidate for Advanced Parkinson's disease, as it prepares for a Phase 1 clinical trial - In July 2025, Serina announced the advancement of SER-270 (POZ-VMAT2i), a once-weekly injectable therapy for tardive dyskinesia[4] - SER-270 aims to address unmet needs in TD treatment, particularly for institutional use and adherence challenges, and may be evaluated for Huntington's disease chorea[4] SER-270 for Tardive Dyskinesia - SER-270 (POZ-VMAT2i) is a once-weekly injectable therapy for tardive dyskinesia, enabled by the POZ Platform[4] - The program aims to address unmet needs in TD treatment, particularly for institutional use and adherence challenges[4] - SER-270 may also be evaluated for Huntington's disease chorea[4] Corporate Developments Serina strengthened its Board of Directors with the appointment of Stephen (Steve) Brannan, M.D., bringing extensive experience in neuroscience and neuropsychiatry drug development to support the company's pipeline advancement - In May 2025, Stephen (Steve) Brannan, M.D. was appointed to Serina's Board of Directors[4] - Dr. Brannan brings over three decades of experience in neuroscience and neuropsychiatry drug development, including leadership roles at Takeda, Novartis, and Karuna Therapeutics[4] Board Appointments - Stephen (Steve) Brannan, M.D., appointed to the Board in May 2025, has a proven track record of leading clinical programs from early development through regulatory approval and commercialization[4] - He led the clinical strategy for KarXT at Karuna Therapeutics, which was key in Karuna's $14 billion acquisition by Bristol Myers Squibb[4] Financing Activities Serina secured $5 million in funding from strategic shareholders for SER-252 development and initiated an 'at-the-market' (ATM) offering program, which has generated $1.2 million in net proceeds as of August 8, 2025 - In April 2025, Serina secured $5 million from strategic shareholders to support the continued development of SER-252[4] - Entered into a Capital on Demand™ Sales Agreement for an ATM offering program to sell up to $13.3 million of common stock[4] - As of August 8, 2025, Serina issued 199,562 shares of common stock via ATM, resulting in net proceeds of $1.2 million[4] $5 Million in Funding - Secured $5 million from strategic shareholders in April 2025[4] - Funding is dedicated to supporting the continued development of SER-252 for Advanced Parkinson's disease[4] - This funding supports preparation to initiate a Phase 1 clinical trial in Q4 2025[4] Financing via ATM - Entered a Capital on Demand™ Sales Agreement in April 2025 for an at-the-market (ATM) offering program[4] - The program allows the company to offer and sell up to $13.3 million of common stock[4] - As of August 8, 2025, 199,562 shares were issued at an average price of $5.95, yielding $1.2 million in net proceeds[4] Second Quarter Operating Results Revenues Serina's revenues for the three months ended June 30, 2025, increased significantly to $130 thousand, up from $51 thousand in the same period of 2024, entirely derived from grant revenues Q2 Revenues (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | | :----- | :------ | :------ | :----- | | Revenues | $130 | $51 | +$79 | - Revenues were comprised entirely of grant revenues from the National Institutes of Health[3] Operating Expenses Total operating expenses for the second quarter of 2025 increased to $5.7 million, compared to $3.9 million for the same period in 2024, driven by increases in both Research and Development (R&D) and General and Administrative (G&A) expenses Q2 Operating Expenses (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--------------- | :------ | :------ | :----- | | Operating Expenses | $5.7 | $3.9 | +$1.8 | Research and Development (R&D) Expenses - The increase was primarily driven by increases in outside research services, consultant spend for research programs, and higher salaries, payroll, and stock-based compensation due to increased headcount[5] - These increases were partially offset by decreases in professional fees for patent maintenance and severance-related costs[5] Q2 R&D Expenses (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :----- | :------ | :------ | :----- | | R&D Expenses | $3.2 | $1.6 | +$1.6 | General and Administrative Expenses - The increase was primarily due to higher stock-based compensation expenses from new option grants and financial consulting expenses for new platforms and software[6] - These increases were partially offset by a decrease in legal fees following the conclusion of post-merger compliance and reporting activities[6] Q2 G&A Expenses (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :----- | :------ | :------ | :----- | | G&A Expenses | $2.5 | $2.3 | +$0.2 | Other (Expense) Income, Net Other expense, net, for Q2 2025 was $0.9 million, a significant increase in expense compared to $9.0 million net income in Q2 2024, primarily due to a $10.3 million change in the fair value of liability classified warrants Q2 Other (Expense) Income, Net (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :----------------------- | :------ | :------ | :----- | | Other (Expense) Income, Net | $(0.9) | $9.0 | $(9.9) | - The $9.9 million increase in expenses was primarily attributable to a $10.3 million change in fair value of liability classified warrants[7] - This was partially offset by a $0.3 million decrease in interest expense[7] Net (Loss) Income Serina reported a net loss attributable to Serina of $6.4 million, or $(0.66) per basic and diluted share, for Q2 2025, a significant decline from a net income of $5.2 million, or $0.61 per basic share and $0.51 per diluted share, in Q2 2024 Q2 Net (Loss) Income and EPS | Metric | Q2 2025 | Q2 2024 | Change | | :-------------------------------- | :------ | :------ | :----- | | Net (Loss) Income (in millions) | $(6.4) | $5.2 | $(11.6) | | Basic EPS | $(0.66) | $0.61 | $(1.27) | | Diluted EPS | $(0.66) | $0.51 | $(1.17) | Liquidity Information Cash and Cash Equivalents and Runway As of June 30, 2025, Serina's cash and cash equivalents totaled $6.0 million, which the company projects will fund operations into the fourth quarter of 2025 Cash and Cash Equivalents | Metric | As of June 30, 2025 | | :-------------------- | :------------------ | | Cash and cash equivalents | $6.0 million | - The Company projects its cash and cash equivalents as of June 30, 2025, to fund operations into the fourth quarter of 2025[10] Company and Technology Overview About Serina Therapeutics Serina Therapeutics is a clinical-stage biotechnology company headquartered in Huntsville, Alabama, focused on developing a pipeline of wholly-owned drug product candidates for neurological diseases and other indications, leveraging its proprietary POZ Platform™ - Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates[11] - Focuses on treating neurological diseases and other indications[11] - Utilizes its proprietary POZ Platform™ drug optimization technology[11] About the POZ Platform™ Serina's proprietary POZ Platform is based on poly(2-oxazoline), a synthetic, water-soluble polymer, engineered to provide greater control in drug loading and precision in release rates for subcutaneous injections. This technology aims to improve the efficacy and safety profiles of drugs, particularly those with narrow therapeutic windows, and has broad application potential, including a non-exclusive license agreement with Pfizer for LNP drug delivery - POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline)[12] - Engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection[12] - Has potential for use across a broad range of payloads and indications, including a non-exclusive license agreement with Pfizer, Inc. for LNP drug delivery formulations[13] Key Pipeline Candidates Serina is advancing two key pipeline candidates, SER-252 (POZ-apomorphine) for Advanced Parkinson's disease and SER-270 (POZ-VMAT2i) for tardive dyskinesia, both leveraging the POZ Platform to improve drug delivery and patient outcomes - SER-252 is an investigational apomorphine therapy for Advanced Parkinson's disease[14] - SER-270 is an investigational once-weekly VMAT2 inhibitor for tardive dyskinesia[15] - Both candidates are developed with Serina's POZ platform to address specific unmet medical needs[14][15] About SER-252 (POZ-apomorphine) - SER-252 is designed to provide continuous dopaminergic stimulation (CDS) to reduce levodopa-related motor complications in Parkinson's disease[14] - Preclinical studies support its potential to provide CDS without skin reactions[14] - Serina plans to advance SER-252 to clinical testing in 2025[14] About SER-270 (POZ-VMAT2i) - SER-270 is an investigational once-weekly VMAT2 inhibitor developed with the POZ platform to address adherence and access challenges in tardive dyskinesia[15] - Its subcutaneous formulation is designed for patients on long-acting injectable antipsychotics, those with dysphagia, and institutionalized populations[16] - Serina is also exploring its development in Huntington's disease chorea[16] Condensed Consolidated Financial Statements Condensed Consolidated Balance Sheets As of June 30, 2025, Serina's total assets increased to $8.941 million from $6.724 million at December 31, 2024, primarily driven by an increase in cash and cash equivalents and additional paid-in capital. Total liabilities also increased to $7.295 million from $6.216 million, mainly due to higher accounts payable and other current liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | Dec 31, 2024 | Change | | :-------------------------------- | :------------ | :----------- | :----- | | Total Assets | $8,941 | $6,724 | +$2,217 | | Cash and cash equivalents | $6,041 | $3,672 | +$2,369 | | Total Liabilities | $7,295 | $6,216 | +$1,079 | | Total Stockholders' Equity | $1,646 | $508 | +$1,138 | | Accumulated Deficit | $(55,579) | $(44,318) | $(11,261) | Condensed Consolidated Statements of Operations For the three months ended June 30, 2025, Serina reported a net loss of $6.462 million, a significant shift from a net income of $5.177 million in the prior year period. This was primarily due to increased operating expenses and a negative change in other (expense) income, net, largely driven by warrant fair value adjustments Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Grant revenues | $130 | $51 | $130 | $56 | | Total operating expenses | $5,695 | $3,917 | $11,553 | $6,243 | | Loss from operations | $(5,565) | $(3,866) | $(11,423) | $(6,187) | | Total other (expense) income, net | $(897) | $9,043 | $139 | $(3,651) | | NET (LOSS) INCOME | $(6,462) | $5,177 | $(11,284) | $(9,838) | | Basic EPS | $(0.66) | $0.61 | $(1.15) | $(1.74) | | Diluted EPS | $(0.66) | $0.51 | $(1.15) | $(1.74) | Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities decreased to $8.072 million from $9.586 million in the prior year period. Net cash provided by financing activities significantly increased to $10.487 million from $8.095 million, primarily due to proceeds from issuance of stock to Juvenescence and Series A convertible preferred stock, resulting in a net increase in cash and cash equivalents of $2.369 million Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(8,072) | $(9,586) | | Net cash used in investing activities | $(46) | $(14) | | Net cash provided by financing activities | $10,487 | $8,095 | | NET CHANGE IN CASH AND CASH EQUIVALENTS | $2,369 | $(1,505) | | Cash and cash equivalents at end of period | $6,041 | $6,114 | - Significant financing activities included proceeds from issuance of stock to Juvenescence ($4,916k) and Series A convertible preferred stock ($4,940k)[26] Additional Information Cautionary Statement Regarding Forward-Looking Statements This section advises against undue reliance on forward-looking statements, which are based on management's current expectations and subject to substantial risks and uncertainties. These risks include those inherent in R&D, clinical trial outcomes, regulatory approvals, financing needs, and competitive developments, as detailed in SEC filings. Serina disclaims any obligation to update these statements - Forward-looking statements are subject to substantial risks and uncertainties that could cause actual results to differ materially[19] - Risks include uncertainties in research and development, clinical trial outcomes, regulatory approvals, and the need for additional financing[19] - Serina disclaims any intent or obligation to update these forward-looking statements[19] Investor Contact Contact information for investor inquiries is provided, including an email address and phone number for Stefan Riley - For inquiries, contact Stefan Riley at sriley@serinatherapeutics.com or (256) 327-9630[20]