Core Insights - Serina Therapeutics' CEO, Steven Ledger, will present at a webinar discussing the impact of new FDA initiatives on drug development and investor expectations in the life sciences sector [1][2] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases and other indications using its proprietary POZ Platform™ [5] - The POZ Platform™ aims to enhance the efficacy and safety profiles of various drug modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs) [5] Event Details - The webinar titled "Navigating the New FDA Era: 2026 Strategic Priorities and the Future of Life Sciences" is scheduled for February 4, 2026, at 8:30 AM Pacific / 11:30 AM Eastern [1] - Participants can submit questions for the CEO before and during the event, which will be hosted by Tribe Public's Managing Member, John F. Heerdink, Jr. [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - TechCreate Group Ltd. (TCGL) is up 99% at $205.71 - VivoSim Labs, Inc. (VIVS) is up 74% at $2.96 - La Rosa Holdings Corp. (LRHC) is up 55% at $4.66 - Sandisk Corporation (SNDK) is up 23% at $668.13 - Springview Holdings Ltd (SPHL) is up 19% at $4.76 - BUUU Group Limited (BUUU) is up 16% at $10.86 - Deckers Outdoor Corporation (DECK) is up 11% at $111.64 - Lumentum Holdings Inc. (LITE) is up 10% at $419.58 - Chanson International Holding (CHSN) is up 10% at $2.15 - Century Therapeutics, Inc. (IPSC) is up 9% at $2.20 [3] Premarket Losers - Kaixin Holdings (KXIN) is down 43% at $5.70 - Brand Engagement Network, Inc. (BNAI) is down 32% at $35.56 - PennyMac Financial Services, Inc. (PFSI) is down 21% at $117.50 - Schneider National, Inc. (SNDR) is down 19% at $24.05 - Moolec Science SA (MLEC) is down 19% at $5.23 - Nuwellis, Inc. (NUWE) is down 18% at $3.43 - Digital Currency X Technology Inc. (DCX) is down 16% at $3.44 - Serina Therapeutics, Inc. (SER) is down 15% at $3.03 - Namib Minerals (NAMM) is down 11% at $5.00 - ZeroStack Corp. (ZSTK) is down 6% at $11.00 [4]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Serina Therapeutics, Inc. (SER) increased by 52% to $4.13 - Digital Currency X Technology Inc. (DCX) rose by 37% to $4.21 - Virtuix Holdings Inc. Class A Common Stock (VTIX) gained 31% to $14.00 - Venu Holding Corporation (VENU) saw a 25% increase to $6.45 - TRX Gold Corporation (TRX) was up 18% to $2.29 - Korro Bio, Inc. (KRRO) increased by 17% to $13.69 - Check-Cap Ltd. (MBAI) rose by 15% to $2.40 - Namib Minerals (NAMM) gained 14% to $7.35 - Austin Gold Corp. (AUST) increased by 11% to $2.84 - SuperX AI Technology Limited (SUPX) was up 9% to $19.12 [3] Premarket Losers - Inuvo, Inc. (INUV) decreased by 26% to $2.42 - Comstock Inc. (LODE) fell by 16% to $2.95 - Joby Aviation, Inc. (JOBY) dropped 14% to $11.40 - ENvue Medical, Inc. (FEED) declined by 12% to $2.02 - Whirlpool Corporation (WHR) was down 10% to $72.25 - USA Rare Earth, Inc. (USAR) decreased by 10% to $22.66 - ServiceNow, Inc. (NOW) fell by 9% to $117.41 - Pinnacle Food Group Limited (PFAI) dropped 9% to $2.15 - BiomX Inc. (PHGE) decreased by 8% to $5.91 - Vyome Holdings, Inc. (HIND) was down 8% to $2.32 [4]

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]

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].