Serina Therapeutics, Inc.(SER) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights Serina Therapeutics reported Q2 2025 results, highlighting clinical program advancements for SER-252 and SER-270, supported by the POZ Platform and strategic financing Second Quarter 2025 Overview Serina Therapeutics announced its Q2 2025 financial results, highlighting significant progress in its clinical development programs, particularly for SER-252 for Parkinson's disease and the advancement of SER-270 for tardive dyskinesia, both leveraging its proprietary POZ Platform - Serina Therapeutics reported Q2 2025 financial results and business highlights, emphasizing progress in its clinical programs for SER-252 and SER-270, enabled by the POZ Platform[1][2] - CEO Steve Ledger highlighted the momentum in development programs, with SER-252 on track for clinic entry later this year and SER-270 advancing for tardive dyskinesia, demonstrating the POZ Platform's ability to create differentiated, long-acting therapies for neurological conditions with high unmet needs[2] Key Business Highlights Serina Therapeutics achieved several key milestones in Q2 2025 and shortly thereafter, including advancing SER-270 for tardive dyskinesia, appointing a new board member with extensive neuroscience experience, securing $5 million in funding for SER-252, and initiating an "at-the-market" (ATM) offering program Advancement of SER-270 for Tardive Dyskinesia Serina advanced SER-270, a once-weekly injectable for tardive dyskinesia, also exploring its potential for Huntington's disease chorea - In July 2025, Serina advanced SER-270 (POZ-VMAT2i), a once-weekly injectable therapy for tardive dyskinesia, designed to address unmet needs in TD treatment, particularly for institutional use and adherence challenges[4] - SER-270 is also being considered for evaluation in Huntington's disease chorea, an indication with high need and limited long-acting injectable options[4] Board Appointments Stephen Brannan, M.D., a neuroscience and neuropsychiatry drug development expert, joined Serina's Board of Directors in May 2025 - Stephen (Steve) Brannan, M.D., with over three decades of experience in neuroscience and neuropsychiatry drug development, was appointed to Serina's Board of Directors in May 2025[4] - Dr. Brannan's experience includes leading clinical programs from early development through regulatory approval and commercialization, notably at Karuna Therapeutics where he led the clinical strategy for KarXT, contributing to Karuna's $14 billion acquisition[4] Funding and Financing Activities Serina secured $5 million in funding for SER-252 development and initiated an "at-the-market" offering program for up to $13.3 million in common stock - Serina secured $5 million in funding from strategic shareholders in April 2025 to support the continued development of SER-252, its lead clinical candidate for Advanced Parkinson's disease, ahead of a planned Phase 1 clinical trial in Q4 2025[4] - In April 2025, Serina entered an ATM offering program to sell up to $13.3 million of common stock, and as of August 8, 2025, had issued 199,562 shares at an average price of $5.95, generating $1.2 million in net proceeds[4] Second Quarter 2025 Financial Performance Serina Therapeutics reported increased revenues but significantly higher operating expenses, leading to a net loss for Q2 2025 Operating Results Summary Serina Therapeutics reported increased revenues for Q2 2025, primarily from grant revenues, but also saw a significant rise in operating expenses, leading to a higher operating loss compared to the same period in 2024 Q2 2025 vs Q2 2024 Operating Results (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | Revenues | $130 | $51 | +$79 | | Operating Expenses | $5,695 | $3,917 | +$1,778 | | Loss from Operations| $(5,565)| $(3,866)| $(1,699) | - Revenues were entirely comprised of grant revenues from the National Institutes of Health[3] Detailed Operating Expenses Both Research and Development (R&D) and General and Administrative (G&A) expenses increased significantly in Q2 2025 compared to Q2 2024, driven by increased research services, headcount, stock-based compensation, and financial consulting, partially offset by decreases in patent maintenance and legal fees Research and Development (R&D) Expenses R&D expenses increased significantly in Q2 2025 due to higher outside research services, consultant spend, and increased headcount, partially offset by reduced patent maintenance R&D Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | R&D Expenses | $3,152 | $1,594 | +$1,558 | - The increase was primarily driven by increases in outside research services, consultant spend for research programs, and an increase in salaries, payroll-related expenses, and stock-based compensation due to increased headcount[5] - These increases were partially offset by decreases in professional fees for patent and intellectual property maintenance and severance-related costs[5] General and Administrative (G&A) Expenses G&A expenses rose in Q2 2025 primarily due to increased stock-based compensation and financial consulting, partially offset by lower legal fees G&A Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------ | :------ | :------ | :----------- | | G&A Expenses | $2,543 | $2,323 | +$220 | - The increase was primarily due to increases in stock-based compensation expenses from new option grants and financial consulting expenses related to 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] Other (Expense) Income, Net Serina reported a net other expense of $0.9 million in Q2 2025, a significant shift from a $9.0 million net income in Q2 2024, primarily due to a $10.3 million change in the fair value of liability classified warrants Other (Expense) Income, Net (in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------------------- | :------ | :------ | :----------- | | Total other (expense) income, net | $(897) | $9,043 | $(9,940) | | Change in fair value of warrants | $(956) | $9,294 | $(10,250) | - The $9.9 million increase in expenses was primarily attributable to a $10.3 million change in the fair value of liability classified warrants, partially offset by a $0.3 million decrease in interest expense[7] Net (Loss) Income Serina Therapeutics reported a net loss 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, in Q2 2024 Net (Loss) Income (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------------------- | :------ | :------ | :----------- | | Net (Loss) Income attributable to Serina | $(6,448)| $5,204 | $(11,652) | | Basic EPS | $(0.66) | $0.61 | $(1.27) | | Diluted EPS | $(0.66) | $0.51 | $(1.17) | Liquidity and Financial Position Serina Therapeutics held $6.0 million in cash and cash equivalents as of June 30, 2025, projected to fund operations into the fourth quarter of 2025 Liquidity Information As of June 30, 2025, Serina Therapeutics had $6.0 million in cash and cash equivalents and projects this to fund operations into the fourth quarter of 2025 Cash and Cash Equivalents (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :---------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $6,041 | $3,672 | +$2,369| - 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 Platform Overview Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates for neurological diseases using its proprietary POZ Platform About Serina Therapeutics Serina Therapeutics is a clinical-stage biotechnology company based in Huntsville, Alabama, focused on developing a pipeline of wholly-owned drug candidates for neurological diseases and other indications, utilizing its proprietary POZ Platform - Serina Therapeutics is a clinical-stage biotechnology company developing a pipeline of wholly-owned drug product candidates to treat neurological diseases and other indications[11] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology[11] About the POZ Platform™ Serina's proprietary POZ Platform, based on poly(2-oxazoline), is designed to optimize drug delivery by providing greater control in drug loading and precision in release rates for subcutaneous injections, aiming to improve efficacy and safety profiles of various therapeutic modalities. The platform has potential for broad applications, including a non-exclusive license agreement with Pfizer for LNP drug delivery - Serina's POZ technology uses a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline) to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection[12] - The platform aims to improve the integrated efficacy and safety profile of multiple modalities, including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs), by maintaining more desirable and stable drug levels in the blood[11][12] - Serina intends to advance additional applications of the POZ Platform through out-licensing, co-development, or other partnerships, including a non-exclusive license agreement with Pfizer, Inc. for use in lipid nanoparticle drug (LNP) delivery formulations[13] Pipeline Candidates Serina is advancing SER-252 for advanced Parkinson's disease and SER-270 for tardive dyskinesia, both utilizing its POZ Platform for improved drug delivery About SER-252 (POZ-apomorphine) SER-252 (POZ-apomorphine) is an investigational therapy for advanced Parkinson's disease, designed to provide continuous dopaminergic stimulation and reduce motor complications - SER-252 (POZ-apomorphine) is an investigational therapy designed to provide continuous dopaminergic stimulation (CDS) for advanced Parkinson's disease, which has been shown to reduce the severity of levodopa-related motor complications[14] - Preclinical studies indicate SER-252's potential to provide CDS without skin reactions, and Serina plans to advance it to clinical testing in 2025[14] About SER-270 (POZ-VMAT2i) SER-270 (POZ-VMAT2i) is an investigational once-weekly VMAT2 inhibitor developed with the POZ Platform to address adherence and access challenges in tardive dyskinesia - SER-270 (POZ-VMAT2i) is an investigational once-weekly VMAT2 inhibitor developed with the POZ Platform to address adherence and access challenges in tardive dyskinesia (TD)[15] - The subcutaneous formulation is designed for patients on long-acting injectable antipsychotics, those with dysphagia, and institutionalized populations, and Serina is also exploring its development for Huntington's disease chorea[16] Financial Statements This section presents Serina Therapeutics' condensed consolidated balance sheets, statements of operations, and statements of cash flows for the reported periods Condensed Consolidated Balance Sheets Serina Therapeutics' balance sheet as of June 30, 2025, shows an increase in total assets and liabilities compared to December 31, 2024, with a notable increase in cash and cash equivalents and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :-------------- | :---------------- | | ASSETS | | | | Cash and cash equivalents | $6,041 | $3,672 | | Total current assets | $7,991 | $5,676 | | TOTAL ASSETS | $8,941 | $6,724 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | $3,561 | $2,366 | | Warrant liability | $3,549 | $3,582 | | TOTAL LIABILITIES | $7,295 | $6,216 | | Total stockholders' equity | $1,646 | $508 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $8,941 | $6,724 | Condensed Consolidated Statements of Operations For the three and six months ended June 30, 2025, Serina Therapeutics reported increased revenues but also significantly higher operating expenses, leading to a net loss for both periods, contrasting with a net income in the prior year's three-month period Condensed Consolidated Statements of Operations (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 attributable to Serina | $(6,448) | $5,204 | $(11,261) | $(9,811) | | 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, Serina Therapeutics experienced a net cash outflow from operating activities but a significant net cash inflow from financing activities, resulting in a positive net change in cash and cash equivalents, increasing its cash balance compared to the beginning of the period Condensed Consolidated Statements of Cash Flows (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 | Additional Information This section provides important disclosures regarding forward-looking statements and contact information for investor inquiries Cautionary Statement Regarding Forward-Looking Statements This section advises readers that the release contains forward-looking statements subject to substantial risks and uncertainties, including those related to R&D, clinical trials, regulatory approvals, and financing. Actual results may differ materially, and Serina disclaims any obligation to update these statements - The release contains forward-looking statements regarding future plans, beliefs, and forecasts, which are subject to substantial risks and uncertainties that could cause actual results to differ materially[19] - Risks include uncertainties inherent in research and development, ability to meet clinical endpoints, regulatory approval processes, Serina's ability to continue as a going concern, and competitive developments[19] - Serina disclaims any intent or obligation to update these forward-looking statements, which speak only as of the date they are made[19] Contact Information Provides contact details for investor inquiries, specifically Stefan Riley, with an email address and phone number - For inquiries, contact Stefan Riley at sriley@serinatherapeutics.com or (256) 327-9630[20]