“Navigating the New FDA Era: 2026 Strategic Priorities and the Future of Life Sciences"  Featuring Serina Therapeutics’ CEO - Wednesday, February 4, 2026 Hear how FDA initiatives in 2026 may impact drug development timelines, review processes, and investor expectations across the life sciences sectorMeet with Serina’s CEO Steven LedgerRegister at New-FDA-Era.TribePublic.com HUNTSVILLE, AL, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechno ...

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]

At 8:15 a.m. ET on Thursday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading hig ...

- Phase 1b clinical site start-up and regulatory activities in Australia underway to support the global registrational program - HUNTSVILLE, AL, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing drug candidates enabled by its proprietary POZ PlatformTM drug optimization technology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) applicat ...

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].