$5 million tranche received under up to $20 million financing agreementIND submitted to FDA and HREC approval obtained in Australia; global trial initiation in Q4 2025 HUNTSVILLE, AL, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the drawdown of the first $5 million tranche from its previously announced financing agreement, which provide ...

Core Viewpoint - Serina Therapeutics has secured an agreement for up to $20 million in financing to advance its lead candidate SER-252 for advanced Parkinson's disease, with the potential for additional funds through warrants [1][2][4]. Financing Details - The financing consists of an unsecured convertible note issued in five tranches, tied to clinical and operational milestones [2][7]. - Each tranche drawn carries 100% warrant coverage, with warrants priced at $5.44, which is 105% of the closing stock price on September 8, 2025 [3][7]. - The financing structure allows for capital deployment in alignment with trial progress, maintaining flexibility for additional funding [2][4]. Clinical Development Plans - Serina plans to submit a U.S. IND application in Q4 2025, incorporating FDA recommendations, and begin patient dosing in Australia in the same quarter [5]. - Following U.S. IND clearance, enrollment in the U.S. is anticipated to start in Q1 2026 [5]. - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate safety, tolerability, and pharmacokinetics [6][8]. Product Overview - SER-252 is an investigational apomorphine therapy designed for continuous dopaminergic stimulation via subcutaneous injection, aimed at reducing motor fluctuations in advanced Parkinson's patients [9]. - The therapy leverages the enFuse™ wearable drug delivery platform to enhance patient comfort and convenience [9]. - Serina's proprietary POZ Platform™ technology aims to improve drug delivery and stability, potentially applicable across various therapeutic areas [10][11].

Core Insights - Serina Therapeutics is advancing SER-252 (POZ-apomorphine) for advanced Parkinson's disease under the 505(b)(2) NDA pathway, with U.S. IND filing planned for Q4 2025 and patient dosing in Australia expected to start in the same quarter [1][4] Company Developments - The FDA's feedback supports the registrational study program for SER-252, indicating that the initial study may be part of a registrational trial program [2][4] - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate safety, tolerability, and pharmacokinetics of SER-252 versus placebo [5] Product Information - SER-252 is designed to provide continuous dopaminergic stimulation via subcutaneous injection, aiming to reduce motor fluctuations in advanced Parkinson's patients [6] - The POZ platform technology enhances drug delivery by providing greater control in drug loading and release rates, potentially improving the efficacy and safety profile of various therapeutic agents [7][8] Future Plans - Serina plans to initiate U.S. enrollment in Q1 2026 following IND clearance, with data from Australian patients contributing to the overall regulatory review package [4] - The company aims to advance a pipeline of POZ-enabled small molecules that may follow similar regulatory pathways [3]

Core Viewpoint - Serina Therapeutics is advancing its lead candidate SER-252 for advanced Parkinson's disease and has reported financial results for Q2 2025, highlighting growth in revenues and increased operating expenses due to R&D investments and administrative costs [1][3][4]. Financial Performance - Revenues for Q2 2025 were $130 thousand, up from $51 thousand in Q2 2024, entirely from NIH grant revenues [3]. - Operating expenses increased to $5.7 million in Q2 2025 from $3.9 million in Q2 2024 [3]. - R&D expenses rose to $3.2 million in Q2 2025, compared to $1.6 million in Q2 2024, driven by higher outside research services and increased headcount [4]. - General and administrative expenses were $2.5 million in Q2 2025, slightly up from $2.3 million in Q2 2024, mainly due to stock-based compensation and financial consulting expenses [5]. - The net loss for Q2 2025 was $6.4 million, or $(0.66) per share, compared to a net income of $5.2 million in Q2 2024 [8][22]. Liquidity and Funding - Cash and cash equivalents totaled $6.0 million as of June 30, 2025, projected to fund operations into Q4 2025 [9]. - In April 2025, Serina secured $5 million from strategic shareholders for the development of SER-252 and entered into a Capital on Demand™ Sales Agreement for an at-the-market offering program of $13.3 million [6]. Product Development - SER-252 is designed to provide continuous dopaminergic stimulation for Parkinson's disease and is expected to enter clinical trials in Q4 2025 [13]. - SER-270, a once-weekly injectable therapy for tardive dyskinesia, has been advanced, addressing unmet needs in treatment adherence [6][14]. Management and Board Updates - Dr. Stephen Brannan was appointed to the Board of Directors, bringing extensive experience in neuroscience and drug development [6].

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) 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](index=1&type=section&id=Second%20Quarter%202025%20Overview) 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=2&type=chunk) [Key Business Highlights](index=1&type=section&id=Key%20Business%20Highlights) 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](index=1&type=section&id=Advancement%20of%20SER-270%20for%20Tardive%20Dyskinesia) 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](index=4&type=chunk) - **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](index=4&type=chunk) [Board Appointments](index=1&type=section&id=Board%20Appointments) 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](index=4&type=chunk) - 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](index=4&type=chunk) [Funding and Financing Activities](index=1&type=section&id=Funding%20and%20Financing%20Activities) 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](index=4&type=chunk) - 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](index=4&type=chunk) [Second Quarter 2025 Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Serina Therapeutics reported increased revenues but significantly higher operating expenses, leading to a net loss for **Q2 2025** [Operating Results Summary](index=1&type=section&id=Operating%20Results%20Summary) 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](index=3&type=chunk) [Detailed Operating Expenses](index=2&type=section&id=Detailed%20Operating%20Expenses) 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](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) 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](index=5&type=chunk) - These increases were partially offset by decreases in professional fees for patent and intellectual property maintenance and severance-related costs[5](index=5&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) 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](index=6&type=chunk) - These increases were partially offset by a decrease in legal fees following the conclusion of post-merger compliance and reporting activities[6](index=6&type=chunk) [Other (Expense) Income, Net](index=2&type=section&id=Other%20(Expense)%20Income,%20Net) 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](index=7&type=chunk) [Net (Loss) Income](index=2&type=section&id=Net%20(Loss)%20Income) 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](index=2&type=section&id=Liquidity%20and%20Financial%20Position) 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](index=2&type=section&id=Liquidity%20Information) 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](index=10&type=chunk) [Company and Platform Overview](index=2&type=section&id=Company%20and%20Platform%20Overview) Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates for neurological diseases using its proprietary **POZ Platform** [About Serina Therapeutics](index=2&type=section&id=About%20Serina%20Therapeutics) 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](index=11&type=chunk) - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology[11](index=11&type=chunk) [About the POZ Platform™](index=2&type=section&id=About%20the%20POZ%20Platform%E2%84%A2) 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](index=12&type=chunk) - 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](index=11&type=chunk)[12](index=12&type=chunk) - 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](index=13&type=chunk) [Pipeline Candidates](index=2&type=section&id=Pipeline%20Candidates) 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)](index=2&type=section&id=About%20SER-252%20(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](index=14&type=chunk) - 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](index=14&type=chunk) [About SER-270 (POZ-VMAT2i)](index=3&type=section&id=About%20SER-270%20(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](index=15&type=chunk) - 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](index=16&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=3&type=section&id=Additional%20Information) This section provides important disclosures regarding forward-looking statements and contact information for investor inquiries [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) 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](index=19&type=chunk) - 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](index=19&type=chunk) - Serina disclaims any intent or obligation to update these forward-looking statements, which speak only as of the date they are made[19](index=19&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) 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](index=20&type=chunk)

Part I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's net loss increased to $11.3 million in H1 2025, with a going concern qualification issued due to insufficient funding Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | 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 & Equity** | | | | Total current liabilities | $3,561 | $2,366 | | 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 Highlights (in thousands, except per share data) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $130 | $56 | | Research and development | $6,103 | $2,700 | | General and administrative | $5,450 | $3,543 | | Loss from operations | $(11,423) | $(6,187) | | NET LOSS | $(11,284) | $(9,838) | | NET LOSS PER COMMON SHARE (BASIC & DILUTED) | $(1.15) | $(1.74) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six months ended June 30, 2025 | Six 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) | - Management has concluded there is **substantial doubt about the Company's ability to continue as a going concern**, as cash and cash equivalents of **$6.0 million** are not expected to be sufficient to fund operations for the next twelve months[35](index=35&type=chunk)[37](index=37&type=chunk) [Note 1. Organization, Business Overview and Liquidity](index=11&type=section&id=Note%201.%20Organization%2C%20Business%20Overview%20and%20Liquidity) Serina is a clinical-stage biotechnology company that faces substantial doubt about its ability to continue as a going concern due to significant operating losses - The company's **POZ drug delivery technology** is designed to improve the efficacy and safety of existing drugs by enabling greater control in drug loading and precision in the rate of release[29](index=29&type=chunk) - On March 26, 2024, the company completed a **reverse merger** with AgeX Therapeutics, Inc, with Legacy Serina surviving as the primary business[27](index=27&type=chunk)[28](index=28&type=chunk) - The company's financial condition, including a **net loss of $11.3 million** for the six months ended June 30, 2025, and cash usage of **$8.1 million** in operating activities, has led to a going concern warning[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 7. Stockholders' Equity](index=19&type=section&id=Note%207.%20Stockholders'%20Equity) The company raised capital through a $4.9 million private placement of preferred stock and initiated a $13.3 million At-the-Market (ATM) offering - On April 8, 2025, the company raised net proceeds of **$4.9 million** from a private placement of 965,250 shares of Series A Convertible Preferred Stock at $5.18 per share[79](index=79&type=chunk) - On April 25, 2025, the company initiated an At-the-Market (ATM) offering to sell up to **$13.3 million** of its common stock; as of June 30, 2025, it had sold 124,454 shares for net proceeds of **$0.6 million**[91](index=91&type=chunk) - The company has several classes of warrants outstanding, including Post-Merger Warrants and Incentive Warrants, which are classified as liabilities and subject to fair value adjustments[83](index=83&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk) [Note 11. Commitments and Contingencies](index=22&type=section&id=Note%2011.%20Commitments%20and%20Contingencies) The company's commitments include operating leases totaling $0.4 million and a $2.0 million partnership with Enable Injections, Inc - In May 2024, the company partnered with Enable Injections, Inc to develop and commercialize SER-252 (POZ-apomorphine) for Parkinson's disease, paying **$2.0 million** for the arrangement[113](index=113&type=chunk) - The company leases its lab and office facilities under non-cancelable operating lease agreements expiring between October 2025 and January 2028[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating expenses increased significantly, and the company's cash position of $6.0 million is insufficient to fund operations for the next year Comparison of Operating Results (in thousands) | Period | Research & Development | General & Administrative | Loss from Operations | | :--- | :--- | :--- | :--- | | **Three months ended June 30, 2025** | $3,152 | $2,543 | $(5,565) | | **Three months ended June 30, 2024** | $1,594 | $2,323 | $(3,866) | | **Six months ended June 30, 2025** | $6,103 | $5,450 | $(11,423) | | **Six months ended June 30, 2024** | $2,700 | $3,543 | $(6,187) | - The increase in R&D expenses for H1 2025 was primarily due to a **$1.8 million increase in outside research services** and a **$1.3 million increase in salaries** and related costs from higher headcount[150](index=150&type=chunk)[151](index=151&type=chunk) - The increase in G&A expenses for H1 2025 was driven by a **$1.2 million increase in salaries and stock-based compensation** and a **$0.8 million increase in consulting fees** for finance functions[153](index=153&type=chunk) - The company's cash on hand of **$6.0 million is not sufficient** to fund operations for the next twelve months, necessitating additional capital raising to avoid curtailing planned operations[162](index=162&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Serina Therapeutics, Inc is not required to provide the information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a **smaller reporting company**[174](index=174&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective as of June 30, 2025, due to several material weaknesses - Management determined that **disclosure controls and procedures were not effective** as of June 30, 2025[175](index=175&type=chunk) - Identified **material weaknesses** include insufficient qualified accounting personnel, lack of segregation of duties, reliance on manual reporting processes, and lack of experience in monitoring internal controls[178](index=178&type=chunk) - The company has begun a **remediation plan**, which includes hiring professionals with public company accounting experience and implementing enhanced processes and system automation[180](index=180&type=chunk)[184](index=184&type=chunk) Part II – OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) As of the reporting date, the company is not a party to any material legal proceedings - The company is **not currently involved in any material legal proceedings**[186](index=186&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Key risks include potential stock price decline from the ATM offering and unpredictable FDA regulatory approval timelines - Sales of a substantial number of shares under the **$13.3 million ATM offering** could cause the company's stock price to decline[187](index=187&type=chunk) - The company faces risks from the inherently unpredictable and lengthy **FDA regulatory approval process**, which could be impacted by external factors like government agency disruptions[188](index=188&type=chunk)[189](index=189&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Information regarding unregistered sales of equity securities has been previously reported - This item was **previously reported**[190](index=190&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information) During the second quarter of 2025, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a **Rule 10b5-1 trading plan** during the three months ended June 30, 2025[193](index=193&type=chunk) [Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications and agreements related to recent securities purchases - A list of exhibits filed with the report is provided, including the Certificate of Designations for the Series A Preferred Stock and the associated Securities Purchase Agreement[194](index=194&type=chunk)

Group 1 - The article does not provide any specific company or industry insights, focusing instead on the author's qualifications and disclosures [1][2][3]

Core Insights - Serina Therapeutics is advancing SER-270, a novel once-weekly injectable VMAT2 inhibitor aimed at treating tardive dyskinesia (TD), addressing significant adherence and access challenges for patients [1][2][3] Group 1: Product Development - SER-270 utilizes Serina's proprietary POZ polymer technology for long-acting, subcutaneous administration, providing a transformative alternative to existing oral VMAT2 inhibitors [2] - The product is designed specifically for underserved TD patients who struggle with daily medication adherence, including those on long-acting injectable antipsychotics [2][7] Group 2: Market Opportunity - TD is a disabling movement disorder primarily affecting patients with chronic psychiatric conditions, with less than 30% of U.S. TD patients diagnosed and fewer than half receiving treatment [3] - The U.S. TD market exceeded $3.7 billion in sales in 2024 and is projected to grow to $5.4 billion by 2030, highlighting the demand for therapies that improve adherence and access [3] Group 3: Expansion Plans - Serina plans to explore the development of POZ-VMAT2i for chorea associated with Huntington's disease, which may offer significant advantages over current oral therapies for affected patients and caregivers [5][6] Group 4: Patient-Centric Approach - The once-weekly injectable format is critical for non-compliant patients, including those in institutional settings and those with dysphagia, thereby improving access to treatment [7]

Core Insights - Serina Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications using its proprietary POZ Platform™ technology [2] Company Overview - Serina Therapeutics is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [2] - The company is developing a pipeline of wholly owned drug product candidates aimed at improving the efficacy and safety profiles of various therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs) [2] Upcoming Events - Steve Ledger, the CEO of Serina, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025, with his discussion set for July 29, 2025, at 2:00 p.m. ET [1]

Core Insights - Serina Therapeutics, Inc. is advancing its lead IND candidate SER-252 for advanced Parkinson's disease using its proprietary POZ Platform drug optimization technology [1][4] - The company granted options to purchase 12,500 shares of common stock to a new non-executive employee as an inducement for employment [1][2] - The exercise price for the options is set at the closing price of Serina's common stock on the date of the grant [2] Company Overview - Serina is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications [4] - The POZ Platform aims to enhance the efficacy and safety profiles of various therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates [4] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [4]