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 ...

– Company addresses FDA requests regarding formulation excipient – Global site start-up activities continue, with first-patient-in for registrational Phase 1b study targeted for Q1 2026, subject to FDA feedback HUNTSVILLE, Dec. 10, 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 Pla ...

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]

Financial Performance - The net loss for Q3 2025 was $4.6 million, or $0.45 per share, compared to a net income of $1.4 million, or $0.16 per share, in Q3 2024[9]. - The net loss attributable to Serina Therapeutics, Inc. for the three months ended September 30, 2025, was $4,585 thousand, compared to a net income of $1,410 thousand in 2024[24]. - Basic net loss per common share for the three months ended September 30, 2025, was $(0.45), compared to $0.16 in 2024[24]. - Total revenues for the three months ended September 30, 2025, were $14 million, compared to $0 million for the same period in 2024, representing a significant increase[24]. Operating Expenses - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024, representing a 20.8% increase[4]. - General and administrative expenses decreased to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, a reduction of 6.9%[7]. - Total operating expenses for the nine months ended September 30, 2025, were $17,945 thousand, compared to $11,569 thousand in 2024, indicating a 55% increase[24]. Research and Development - R&D expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, a rise of 50% driven by outsourced research services and clinical activities[6]. - Research and development expenses increased to $3,651 thousand for the three months ended September 30, 2025, up from $2,415 thousand in 2024, reflecting a 51% increase[24]. - SER-270 is on track for formulation optimization and pre-IND activities in 2026, targeting tardive dyskinesia treatment[5][16]. - The SER-252 registrational study is designed to evaluate safety and efficacy in adults with Parkinson's disease, involving 40 participants in the single-ascending-dose component[15]. Cash and Financing - Cash and cash equivalents increased to $8.6 million as of September 30, 2025, compared to $3.7 million as of December 31, 2024[10][22]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $(11,922) thousand, slightly improved from $(12,548) thousand in 2024[26]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $16,931 thousand, compared to $8,181 thousand in 2024, showing a 107% increase[26]. - Cash and cash equivalents at the end of the period on September 30, 2025, were $8,620 thousand, up from $3,235 thousand at the end of the same period in 2024[26]. - Serina secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million drawn in September 2025[5]. - As of November 7, 2025, Serina issued 474,712 shares of common stock at a gross average price of $6.00, resulting in net proceeds of $2.8 million[5]. Shareholder Information - The weighted average number of common shares outstanding for the three months ended September 30, 2025, was 10,339 thousand, compared to 8,851 thousand in 2024, reflecting a 17% increase[24]. - Total other income, net for the three months ended September 30, 2025, was $1,797 thousand, down from $6,695 thousand in 2024, indicating a decrease of 73%[24]. Regulatory Milestones - The FDA supported advancing SER-252 under a 505(b)(2) NDA pathway, marking a significant regulatory milestone[3][5].

Financial Performance - The company reported an operating loss of $6.4 million for the nine months ended September 30, 2025, compared to a loss of $5.3 million for the same period in 2024, indicating an increase in losses year-over-year [147]. - For the three months ended September 30, 2025, net loss was $4.6 million, compared to a net income of $1.4 million for the same period in 2024, representing a decrease of $5.98 million [168]. - The net loss for the nine months ended September 30, 2025 was $15.9 million, compared to a net loss of $8.5 million in the same period of 2024 [193][194]. - Other income for the three months ended September 30, 2025, was $1.8 million, down from $6.7 million in 2024, a decrease of $4.9 million [175]. Cash and Financing - As of September 30, 2025, the company had an accumulated deficit of $60.2 million and $8.6 million in cash and cash equivalents, raising concerns about its ability to continue as a going concern [148]. - The company had $8.6 million in cash and cash equivalents, with significant reliance on financing from stock issuances and convertible notes [178]. - The company entered into a Securities Purchase Agreement resulting in net proceeds of $4.9 million from the issuance of Series A Convertible Preferred Stock [179]. - The company has an at-the-market offering program with a potential aggregate offering price of up to $13.3 million, having sold 385,851 shares at an average price of $5.96, resulting in net proceeds of $2.2 million [181]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $16.9 million, an increase of 107.0% from $8.2 million in 2024 [195][196]. - The financing activities in 2025 included $4.9 million from the issuance of common stock to Juvenescence and $4.9 million from a securities purchase agreement [195]. Research and Development - The company expects to incur substantial expenditures for the development of its product candidates and anticipates that research and development expenses will continue to increase significantly [149]. - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approval is obtained for its product candidates [150]. - The company announced a clinical hold on its IND application for SER-252, its lead development program for advanced Parkinson's disease, due to the FDA's request for additional information [162]. - The company plans to advance SER 252 into Phase I clinical trials and further invest in its pipeline, including hiring additional personnel to support development efforts [155]. - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and other development activities [158]. - Research and development expenses increased to $3.6 million for the three months ended September 30, 2025, up from $2.4 million in 2024, marking a $1.2 million increase [170]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $17.9 million, compared to $11.6 million for the same period in 2024, an increase of $6.4 million [174]. - General and administrative expenses are projected to rise over the next several years to support ongoing research and development, manufacturing activities, and compliance with public company regulations [164]. - General and administrative expenses decreased to $2.7 million for the three months ended September 30, 2025, from $2.9 million in 2024, a net decrease of $0.2 million [173]. Risks and Uncertainties - The company faces numerous risks and uncertainties in product development, including the potential need for additional clinical trials and the unpredictability of regulatory approvals [162]. - The accumulated deficit as of September 30, 2025, was $60.2 million, raising substantial doubt about the company's ability to continue as a going concern [186].

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 has drawn down the first $5 million tranche from a financing agreement that allows for up to $20 million in funding based on achieving specific development milestones [1][2] - The funds will be utilized to advance the registrational trial of SER-252, aimed at treating advanced Parkinson's disease [1][3] Financing and Milestones - The initial $5 million tranche was received as per the financing agreement, with future tranches contingent on meeting defined development milestones, including patient enrollment in the clinical trial [2] - The financing milestone is crucial for progressing SER-252 into the planned registrational trial, addressing the unmet needs of advanced Parkinson's disease patients [3] Clinical Trial Details - The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial, consisting of single-ascending-dose and multiple-ascending-dose components, involving a total of 88 participants [4] - The study aims to evaluate the safety, tolerability, and pharmacokinetics of SER-252 compared to placebo, with exploratory efficacy measures including MDS-UPDRS motor scores [4] Product Overview - SER-252 is an investigational apomorphine therapy developed using Serina's POZ platform, designed for continuous dopaminergic stimulation via subcutaneous injection [5] - The therapy aims to reduce motor fluctuations and improve daily on time for patients with advanced Parkinson's disease, utilizing Enable Injections' enFuse wearable drug delivery platform for enhanced patient comfort [5] Company Background - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications, leveraging its POZ Platform for improved efficacy and safety profiles [6] - The company is headquartered in Huntsville, Alabama, and is positioned on the campus of the HudsonAlpha Institute of Biotechnology [6]

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]