POZ-apomorphine (SER-252) / Serina Therap - LARVOL DELTA

Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program (GlobeNewswire) - "Serina’s complete response, submitted on December 9, 2025, includes: A detailed data package supporting the proposed use of trehalose as a subcutaneous excipient at the intended dose, including comparative information to approved products containing trehalose and additional nonclinical analyses; and A revised protocol to initiate the single ascending dose (SAD) phase....The Company now expects first-patient-in ('FPI') in Q1 2026, subject to timely resolution of the clinical hold and customary regulatory and ethics approvals."

FDA event • New P1 trial • Parkinson's Disease

Serina Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Investigational New Drug (IND) application for SER-252, Serina’s lead development program for advanced Parkinson’s disease. (The Manila Times) - "The FDA has requested additional information related to a commonly used excipient in the formulation. The feedback does not relate to the active drug substance or its proposed mechanism of action...Serina expects to receive the FDA’s formal clinical-hold letter within 30 days and will provide an update once it has aligned with the FDA on next steps and timelines...The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson’s disease and motor fluctuations."

FDA event • Parkinson's Disease

Serina Therapeutics Draws First $5 Million Funding Tranche to Support Registrational Trial of SER-252 in Parkinson’s Disease (GlobeNewswire) - "$5 million tranche received under up to $20 million financing agreement....The company remains on track to initiate its registrational study in the fourth quarter of 2025, with first patient dosing expected before the end of the year....The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson’s disease and motor fluctuations."

Financing • New P1 trial • Parkinson's Disease

Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway (GlobeNewswire) - "Serina plans to include a pharmacokinetic (PK) bridging component to an approved apomorphine product, consistent with a 505(b)(2) NDA strategy. The FDA’s feedback indicates that Serina’s initial study may be designed and conducted as a component of a registrational trial program....U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026."

FDA event • IND • Parkinson's Disease

Phosphorylation-mediated Regulation of the NADPH-dependent Glutamate Dehydrogenase, SpGdh1, from Schizosaccharomyces pombe. (PubMed, J Biol Chem) - "Ser252 directly interacted with the 2'-phosphate group of the adenine ribose moiety of NADP+, suggesting that the phosphorylation of Ser252 interfered with NADP+ binding...Therefore, the Ser to Glu replacement caused net shifts in the coenzyme specificities (NADPH to NADH and NADP+ to NAD+) of 55- and 2900-fold, respectively. This is the first study to reveal the effects of the phosphorylation of SpGdh1 on its activity."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Serina Therapeutics Secures $5 Million in Funding to Support Advancement of SER-252 into Clinical Development in Advanced Parkinson's Disease (GlobeNewswire) - "Serina Therapeutics...announced the closing of a $5 million financing from strategic shareholders. Proceeds from the transaction will support the continued development of SER-252 (POZ-apomorphine), Serina's lead clinical candidate for Advanced Parkinson's disease, as the company prepares to initiate a Phase 1 clinical trial in the fourth quarter of 2025....In connection with the financing, Serina issued 965,250 shares of convertible preferred stock at $5.18 per share, equivalent to the closing price of its common stock on April 7, 2025."

Financing • New P1 trial • Parkinson's Disease

Serina Therapeutics Receives Second $5 Million Tranche to Strengthen Cash Position Ahead of Phase 1 Clinical Trial in Advanced Parkinson's Disease Patients (GlobeNewswire) - "Serina Therapeutics, Inc...today announced the successful closing of the second $5 million tranche of its previously announced $10 million equity financing with strategic shareholder JuvVentures (UK) Limited. The transaction provides Serina with funding to continue advancing SER-252 (POZ-apomorphine), enabled by its proprietary POZ Platform drug optimization technology, into a Phase 1 clinical trial in advanced Parkinson's disease patients in the second half of 2025. The closing represented the second tranche of the $10 million total financing announced on December 2, 2024."

Financing • New P1 trial • Parkinson's Disease

Computational Investigation of Urolithin A Binding Affinities and Dynamics on Targets Implicated in Anti-inflammatory, Antioxidant, and Neurodegenerative Pathways. (PubMed, Free Radic Biol Med) - "Molecular docking studies revealed the strong affinity for receptors involved in inflammation activities, including human p38 MAP kinase (4DLI) with -10.1 kcal/mol interacting with SER252, LYS249, and ASP294 residues...Molecular Dynamics simulations at 100 ns of Urolithin A compared with reference 4DLI. The Urolithin A-4DLI complex exhibited greater stability than the reference receptor, as confirmed by RMSD, RMSF, Radius of Gyration, Hydrogen bond, and SASA analyses."

Journal • CNS Disorders • Inflammation

Serina Therapeutics Secures $10 Million Financing to Continue Advancing Lead IND Candidate into Phase 1 Clinical Trial in Advanced Parkinson's Disease Patients (GlobeNewswire) - "Serina Therapeutics...announced a $10 million equity financing with strategic shareholder JuvVentures (UK) Limited. The transaction provides Serina with funding to continue advancing SER-252 (POZ-apomorphine), enabled by its proprietary POZ Platform drug optimization technology, into a Phase 1 clinical trial in advanced Parkinson's disease patients in the second half of 2025. Under the terms of the funding agreement, Serina will issue one million shares of common stock at $10 per share, a 120% premium to the closing price on November 26, 2024. The financing will be delivered in two tranches: the first $5.0 million tranche was received November 27, 2024, and the second $5.0 million tranche by January 31, 2025."

Financing • New P1 trial • Parkinson's Disease

Polo-like kinase 2 promotes microglial activation via regulation of the HSP90α/IKKβ pathway. (PubMed, Cell Rep) - "Furthermore, phosphoproteomic analysis pinpoints Ser252 and Ser263 on HSP90α as novel phosphorylation targets of PLK2. Lastly, conditional knockout of PLK2 in microglial cells dramatically ameliorates neuroinflammation and subsequent dopaminergic neuron loss in an intracranial LPS-induced mouse Parkinson's disease (PD) model. The present study reveals that PLK2 promotes microglial activation through the phosphorylation of HSP90α and subsequent activation of the IKKβ-NF-κB signaling pathway."

Journal • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • CDC37 • HSP90AA1 • PLK2

SlCPK27 cross-links SlHY5 and SlPIF4 in brassinosteroid-dependent photo- and thermo-morphogenesis in tomato. (PubMed, Proc Natl Acad Sci U S A) - "SlCPK27 interacts with and phosphorylates SlPIF4 at Ser-252 and Ser-308 phosphosites to promote its degradation...Such a SlHY5-SlCPK27-SlPIF4-BR cascade not only plays a crucial role in photomorphogenesis but also regulates thermomorphogenesis. Our results uncover a previously unidentified mechanism that integrates Ca2+ signaling with the light signaling pathways to regulate plant growth by modulating BR biosynthesis in response to changes in ambient light and temperature."

Journal

Serina Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Highlights (GlobeNewswire) - "Advancement of SER-252. The Company is advancing its lead drug candidate, SER-252 (POZ-apomorphine), for the treatment of advanced Parkinson’s Disease. The Company anticipates submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration with plans to initiate a Phase 1 clinical trial in 2025."

IND • CNS Disorders • Parkinson's Disease

Enable Injections and Serina Therapeutics Announce Agreement to Develop SER-252 in Combination with enFuse for Advanced Parkinson’s Disease (GlobeNewswire) - "Enable Injections, Inc...announced a partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for the treatment of Parkinson’s disease....Serina plans to advance SER-252 to clinical testing in 2025....Under the terms of the agreement, Serina will obtain a worldwide, exclusive license to the enFuse platform for an upfront and future milestone payments. Enable will also be entitled to product sales and single digit royalties."

Licensing / partnership • CNS Disorders • Parkinson's Disease

Serina Therapeutics Announces Completion of Merger with AgeX Therapeutics (GlobeNewswire) - "Serina Therapeutics...announced the closing of its previously announced merger with a wholly-owned subsidiary of AgeX Therapeutics, Inc. The combined company will operate under the name Serina Therapeutics and will trade on the NYSE American market under the ticker symbol “SER” effective with the open of business on Wednesday, March 27, 2024....Serina will focus on the advancement of its lead drug candidate, SER-252 (POZ-apomorphine) for the treatment of advanced Parkinson’s Disease through pre-clinical studies towards the goal of an investigational new drug submission or 'IND' to the Food and Drug Administration for the initiation of a Phase I clinical trial during the fourth quarter of 2024."

IND • M&A • Parkinson's Disease

Ser252Asn Mutation Introduces a New N-Linked Glycosylation Site and Causes Type IIb Protein C Deficiency. (PubMed, Thromb Haemost) - " The new N-glycosylation site (NTT) resulting from the mutation of Ser252 to Asn252 in PROC affects the overall structure of the protease, thereby adversely affecting the anticoagulant function of protein C. This modification has a negative impact on both TM-promoted activation of protein C and APC cleavage of FVa, ultimately leading to thrombosis in the patient."

Journal • Cardiovascular • Hematological Disorders • Targeted Protein Degradation • Thrombosis • PROC

Serina Therapeutics and AgeX Therapeutics Enter into Merger Agreement (Businesswire) - "Serina Therapeutics, Inc...entered into a merger agreement with AgeX Therapeutics, Inc...on August 29, 2023, under which Serina will merge with a wholly-owned subsidiary of AgeX in an all-stock transaction. The combined company will continue under the Serina Therapeutics name and will focus on advancing Serina’s pipeline of small molecule drug candidates targeting central nervous system ('CNS') indications, enabled by the company’s proprietary POZ Platform™ delivery technology....The combined company will focus on advancing Serina’s lead drug candidate (SER-252, POZ-apomorphine) for the treatment of advanced Parkinson’s Disease through pre-clinical studies, with the goal of submitting an investigational new drug submission ('IND') to the Food and Drug Administration for the initiation of a Phase I clinical trial during the fourth quarter of 2024."

IND • Licensing / partnership • CNS Disorders • Parkinson's Disease