Core Insights - The FDA has cleared Serina Therapeutics' Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson's disease, marking a significant milestone for the company [1][2][3] 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 for drug optimization [4] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [4] POZ Platform Technology - The POZ technology is based on a synthetic, water-soluble polymer called poly(2-oxazoline), designed to enhance drug loading control and precision in drug release rates via subcutaneous injection [5] - This technology aims to improve the efficacy and safety profiles of various drug modalities, including small molecules and RNA-based therapeutics [5] - Serina plans to advance additional applications of the POZ platform through partnerships, including a non-exclusive license agreement with Pfizer for lipid nanoparticle drug delivery formulations [6] SER-252 Development - SER-252 is an investigational apomorphine therapy developed using the POZ platform, intended to provide continuous dopaminergic stimulation (CDS) to reduce levodopa-related motor complications in Parkinson's disease [7] - Preclinical studies suggest that SER-252 may offer CDS without causing skin reactions, addressing a significant unmet medical need in the treatment of advanced Parkinson's disease [7]

Core Viewpoint - Serina Therapeutics, Inc. is facing potential delisting from the NYSE due to insufficient stockholders' equity and losses in recent fiscal years, necessitating a compliance plan to regain listing standards by July 2027 [1][2]. 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 [3]. - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [3]. POZ Platform Technology - The POZ technology is based on a synthetic polymer that enhances drug delivery by improving control over drug loading and release rates [4]. - This technology aims to address limitations of existing drugs, such as toxicity and short half-life, by maintaining stable blood levels of therapeutic agents [4]. SER-252 Development - SER-252 is an investigational therapy designed to provide continuous dopaminergic stimulation for Parkinson's disease, potentially reducing motor complications associated with traditional treatments [6]. - Preclinical studies indicate that SER-252 may offer therapeutic benefits without causing skin reactions [6]. Compliance and Listing Status - The company must submit a plan by February 8, 2026, detailing actions to regain compliance with NYSE listing standards by July 9, 2027 [2]. - If the compliance plan is accepted, Serina will remain listed during the "Cure Period" and will undergo periodic reviews [2].

Core Viewpoint - Serina Therapeutics has appointed Dr. Joshua Thomas as Vice President and Head of Chemistry to enhance its drug optimization efforts for its lead candidate SER-252, aimed at treating advanced Parkinson's disease using the proprietary POZ Platform technology [1][3]. Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications, utilizing its POZ Platform to improve the efficacy and safety profiles of various therapeutic modalities [4][5]. - The POZ technology is based on a synthetic polymer that allows for better control in drug loading and release rates, addressing limitations of existing drugs [5]. Leadership Appointment - Dr. Joshua Thomas brings over 13 years of experience from Mersana Therapeutics, where he contributed significantly to discovery chemistry and the development of antibody drug conjugate technologies [2][3]. - His expertise includes developing cytotoxic payloads and designing bioconjugation systems, aligning with Serina's strategy to advance its small molecule opportunities [2][3]. Strategic Goals - The company aims to expand the POZ platform into new therapeutic modalities and enhance its drug development capabilities [3]. - Dr. Thomas expressed enthusiasm about leading the chemistry efforts to deliver patient-focused therapies, highlighting the strength of Serina's scientific foundation [4]. Product Development - SER-252, an investigational apomorphine therapy developed with the POZ platform, is designed to provide continuous dopaminergic stimulation, potentially reducing motor complications in Parkinson's disease [7]. - Preclinical studies suggest SER-252 may offer benefits without skin reactions, with plans to advance to clinical testing in 2025 [7]. Collaborative Efforts - Serina is exploring additional applications of the POZ platform through partnerships, including a non-exclusive license agreement with Pfizer for lipid nanoparticle drug delivery formulations [6].

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]