HUNTSVILLE, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ PlatformTM drug optimization technology, received a notice from the New York Stock Exchange ("NYSE") that it is below the continued listing criteria under Sections 1003(a)(i) and (ii) of the NYSE's listing standard ...

HUNTSVILLE, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ PlatformTM drug optimization technology, today announced the appointment of Joshua Thomas, Ph.D., as Vice President and Head of Chemistry. He will oversee internal and external chemistry efforts to optimize POZ-bas ...

Core Insights - Serina Therapeutics has submitted a complete response to the FDA regarding the clinical hold on its lead drug candidate SER-252 for advanced Parkinson's disease, addressing concerns related to a formulation excipient [1][2][3] - The company is targeting the first patient in for the registrational Phase 1b study in Q1 2026, contingent on FDA feedback and resolution of the clinical hold [1][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases, utilizing its proprietary POZ Platform for drug optimization [4] - The POZ technology is based on a synthetic polymer that enhances drug delivery and stability, potentially improving the efficacy and safety profiles of various therapeutic modalities [5] Drug Development Details - SER-252 is an investigational apomorphine therapy designed to provide continuous dopaminergic stimulation, which may reduce levodopa-related motor complications in Parkinson's disease [8] - The complete response to the FDA includes a detailed data package supporting the use of trehalose as a subcutaneous excipient and a revised protocol for the single ascending dose phase of the trial [7]

Core Insights - Serina Therapeutics is advancing its lead investigational drug SER-252 for advanced Parkinson's disease, with a key milestone achieved in FDA alignment for a 505(b)(2) NDA pathway [2][6] - The company reported a net loss of $4.6 million for Q3 2025, compared to a net income of $1.4 million in Q3 2024, indicating a significant shift in financial performance [8][22] - Serina has secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million already drawn [6] Financial Performance - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024 [3] - Research and Development (R&D) expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, driven by higher outsourced research services and clinical activities [4] - General and Administrative expenses decreased slightly to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, attributed to reduced compensation costs [5] - Other income for Q3 2025 was $1.8 million, a decrease from $6.7 million in Q3 2024, primarily due to changes in fair value of liability classified warrants [7] Liquidity and Capital Structure - As of September 30, 2025, cash and cash equivalents totaled $8.6 million, a significant increase from $3.7 million at the end of 2024 [9][20] - The company has entered into an At-the-Market (ATM) equity program allowing it to sell up to $13.3 million of common stock, with $2.8 million net proceeds from shares issued as of November 7, 2025 [6] Regulatory and Development Updates - The FDA has placed the IND for SER-252 on clinical hold pending additional information, but this does not relate to the active drug substance [6] - Serina is advancing SER-270 for tardive dyskinesia, with plans to complete formulation optimization and pre-IND activities in 2026 [6] - The SER-252 registrational study is designed to evaluate safety, tolerability, and pharmacokinetics, with a focus on motor fluctuations in Parkinson's disease [14]

Core Viewpoint - Serina Therapeutics has announced that the FDA has placed a clinical hold on its IND application for SER-252, a treatment for advanced Parkinson's disease, due to requests for additional information regarding an excipient in the formulation, not related to the active drug substance or its mechanism of action [1][2][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases using its proprietary POZ Platform technology [8] - The company is headquartered in Huntsville, Alabama, and aims to improve the efficacy and safety profiles of various therapeutic modalities [8] SER-252 Development - SER-252 is an investigational apomorphine therapy designed for continuous dopaminergic stimulation via subcutaneous injection, targeting motor fluctuations in advanced Parkinson's patients [6] - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial aimed at evaluating the safety, tolerability, and pharmacokinetics of SER-252 [5] FDA Interaction - The FDA has indicated prior support for Serina's development approach for SER-252 under a 505(b)(2) NDA pathway, and the company expects to receive a formal clinical-hold letter within 30 days [2][3] - The CEO of Serina expressed confidence in the potential of SER-252 and the company's commitment to addressing the FDA's feedback promptly [3] Broader Pipeline - In addition to SER-252, Serina is advancing its POZ Platform-based pipeline, which includes SER-270, a once-weekly injectable therapy for tardive dyskinesia [4]

Core Insights - Serina Therapeutics has launched a comprehensive corporate communications platform aimed at providing timely and transparent updates to various stakeholders including patients, clinicians, investors, and the scientific community [1][2]. Communication Initiative - The new platform enhances Serina's communication channels, offering clear and accessible information regarding the company's programs, regulatory progress, and scientific advancements [2]. - It will include regular digital updates, educational resources, multimedia content, and expert commentary from company leadership and scientific advisors [2][8]. Leadership Perspective - The CEO of Serina emphasizes the importance of clear communication in biotechnology, especially as the company prepares to initiate the trial of SER-252 for Parkinson's disease [3]. - The platform is intended to be a vital resource for stakeholders, ensuring they can follow the company's progress in developing new treatment options [3][4]. SER-252 Study Overview - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety, tolerability, and pharmacokinetics of SER-252 in adults with Parkinson's disease [5]. - The study will involve multiple cohorts and will be conducted across sites in the U.S. and Australia [5]. SER-252 Drug Profile - SER-252 is an investigational apomorphine therapy developed using Serina's POZ platform, aimed at providing continuous dopaminergic stimulation through subcutaneous injections [6]. - This therapy is designed to reduce motor fluctuations in advanced Parkinson's patients, enhancing patient comfort and convenience through a wearable drug delivery platform [6]. Company Background - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications [7]. - The company's POZ Platform aims to improve the efficacy and safety profiles of various therapeutic modalities [7].

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 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]

Core Insights - Serina Therapeutics, Inc. is set to present its innovative drug optimization technology at a webinar focused on Parkinson's care, highlighting the limitations of current treatments and the potential of its proprietary drug candidate SER-252 [1][2][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates aimed at treating neurological diseases and other indications, utilizing its proprietary POZ Platform for drug optimization [5] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [5] Product and Technology - SER-252 is a polymer conjugate of apomorphine designed to provide continuous dopaminergic stimulation (CDS), aiming for smoother and longer-lasting symptom control for Parkinson's patients [2] - The POZ Platform is a next-generation drug optimization system that has the potential to enhance the safety, duration, and tolerability of various therapeutics, including small molecules and RNA-based therapeutics [2][5] Event Details - The webinar titled "New Drug Optimization Platform to Transform Parkinson's Care" will take place on June 26, 2025, featuring a presentation by CEO Steve Ledger and a Q&A session for attendees [1][3]

Core Insights - Serina Therapeutics congratulates its strategic partner Juvenescence Ltd. for securing $150 million in Series B financing led by M42, which will enhance their drug development capabilities [1][2][3] - The partnership aims to establish a drug development hub in Abu Dhabi, integrating AI-enabled drug discovery with advanced clinical infrastructure to expedite the creation of innovative therapies targeting age-related diseases [2][3] - Juvenescence's leadership has a proven track record in biopharma, having previously led significant deals and developed medicines with peak annual sales totaling $30 billion [7][8] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications, utilizing its proprietary POZ Platform to enhance the efficacy and safety of various therapeutic modalities [4] - Juvenescence is an AI-enabled biotech company dedicated to extending healthy lifespan by targeting core aging mechanisms to treat age-related diseases [6][8] - M42, a global health company, combines AI, technology, and genomics to innovate healthcare solutions, operating over 480 facilities across 26 countries [9][11]