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Serina Therapeutics Completes Strategic Combination, Set to Trade on NYSE American as "SER"
Serina Therapeutics has finalized its combination with a subsidiary of AgeX Therapeutics, marking a significant milestone for the clinical-stage biopharmaceutical developer. The merger brings together two organizations focused on neurological disease treatment, with the resulting entity commencing trading on NYSE American under ticker symbol “SER” beginning March 27, 2024.
Transaction Structure and Shareholder Composition
The combination results in a restructured ownership model, with approximately 10.1 million shares of common stock outstanding on a fully-diluted basis (excluding warrants). Prior Serina shareholders retain roughly 75% ownership, while former AgeX shareholders hold approximately 25%. The new CUSIP identifier for the merged entity is 81751A108. Steven Ledger takes the helm as Interim Chief Executive Officer for the combined organization.
J. Milton Harris, Ph.D., Board Chair of Serina, highlighted the strategic importance: “This combination represents the fruition of extensive development efforts and positions us to advance our polyoxazoline-drug conjugate technology into clinical testing. The combined entity will pursue expansion of additional clinical programs, enhance our LNP and ADC platform capabilities, and unlock opportunities with a broader investor base.”
Lead Product Development Trajectory
The flagship asset, SER-252 (POZ-apomorphine), represents a novel approach to treating advanced Parkinson’s Disease. The preclinical development program for this lead candidate commenced in August 2023, with completion targeted for the fourth quarter of 2024. Following preclinical study completion, the organization intends to submit an investigational new drug application to the Food and Drug Administration during Q4 2024, paving the way for Phase I clinical trial initiation in 2025.
SER-252 demonstrates potential advantages over existing therapies. The compound is engineered for subcutaneous administration once or twice weekly—a significant improvement over current infusion-based apomorphine treatments that require 12-16 hour continuous infusions. Preclinical evidence in non-human primates suggests the candidate may be administered conveniently at home without the skin reaction profile associated with conventional apomorphine therapy, where approximately 40% of patients experience significant dermatological complications including permanent scarring.
Therapeutic Rationale and Unmet Medical Need
The development of advanced Parkinson’s Disease therapeutics addresses a substantial clinical problem. Levodopa (L-DOPA) remains the cornerstone therapy but carries a significant burden: approximately 90% of patients receiving L-DOPA for a decade develop levodopa-induced dyskinesias (LIDS)—irreversible movement complications that substantially impact quality of life. While apomorphine (marketed as Apo-go in the European Union) provides dopaminergic stimulation and reduces “OFF” time (periods of motor dysfunction), its administration challenges and skin toxicity have limited adoption in certain markets.
Serina’s preclinical modeling suggests SER-252 could provide linear dose kinetics and stable blood levels, potentially allowing some patients to taper completely off L-DOPA and thus mitigate LIDS development. The candidate demonstrates potential for reducing daily “OFF” time while maintaining “ON” time (periods of functional motor capability) without dyskinesia complications.
Proprietary POZ Platform Technology
The POZ Platform represents Serina’s core technological differentiator—a synthetic, water-soluble polymer system (poly(2-oxazoline)) engineered for superior drug loading control and precise release rate management. Unlike conventional polyethylene glycol (PEG) based systems, the POZ approach enables formulation of challenging molecules while maintaining stable systemic concentrations suitable for subcutaneous delivery.
The technology extends beyond neurological applications. Serina maintains a non-exclusive licensing agreement with Pfizer for POZ polymer integration into lipid nanoparticle (LNP) delivery formulations, with implications for RNA therapeutic development. The combined organization plans to advance additional POZ-enabled candidates through out-licensing, co-development partnerships, or other collaborative arrangements.
Product Pipeline and Development Focus
The merged entity concentrates on a wholly-owned pipeline of POZ-conjugated drug candidates targeting central nervous system indications including Parkinson’s Disease, epilepsy, and pain conditions. The organizational strategy emphasizes expanding the POZ Platform’s applicability across diverse therapeutic payloads while systematically advancing candidates through preclinical and clinical development phases.
Legal and Regulatory Framework
Bradley Arant Boult Cummings LLP served as legal counsel to Serina, while Gibson, Dunn & Crutcher LLP represented AgeX Therapeutics throughout the transaction process.
The combination carries inherent risks and uncertainties typical of clinical-stage biopharmaceutical development, including regulatory approval timelines, clinical trial execution challenges, intellectual property protection requirements, financing adequacy, and commercial development capabilities. The organization’s ability to maintain NYSE American listing compliance, successfully commercialize future candidates, and preserve key personnel and business relationships represents additional considerations for stakeholders. Market developments, competitive pressures, and macroeconomic factors including global health events may materially impact forward guidance and operational results.