SER-270

- Novel once-weekly injectable VMAT2 inhibitor targets underserved patients with serious adherence and access challenges – - Potential expansion into Huntington’s chorea – an underserved indication with high need for long-acting VMAT2 therapy - July 29, 2025 -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the advancement of its novel product candidate, SER-270, a proprietary POZ-conjugated vesicular monoamine transporter 2 (VMAT2) inhibitor in development for the treatment of tardive dyskinesia (TD). SER-270, also referred to as POZ-VMAT2i, leverages Serina’s proprietary POZ polymer technology to enable long-acting, once weekly subcutaneous administration, offering a potentially transformative alternative to existing oral VMAT2 inhibitors. The candidate is designed to meet the needs of underserved TD patients who struggle with daily medication adherence, including those already managed with long-acting injectable (LAI) antipsychotics. TD is a disabling and often stigmatizing movement disorder caused by long-term exposure to antipsychotic medications. It predominantly affects those with chronic psychiatric conditions such as schizophrenia and bipolar disorder who may have difficulty adhering to complex daily medication regimens. While oral VMAT2 inhibitors are the only approved class for TD, uptake remains modest due to underdiagnosis, low disease awareness among clinicians, and the challenges of ensuring daily medication adherence in complex, high-risk populations. It is estimated that fewer than 30% of U.S. TD patients are diagnosed, and less than half of those receive pharmacologic treatment. Despite these challenges, the U.S. TD market exceeded $3.7 billion in sales in 2024, driven by increased recognition and broader reimbursement. Analysts project the market to grow to $5.4 billion by 2030, underscoring the significant opportunity for differentiated therapies that address adherence, access, and administration barriers. Once-weekly, long-acting injectable administration, critical for patients non-compliant with daily oral medications, including those currently managed with long-acting injectable (LAI) antipsychotics. Improved access for institutionalized patients, where daily oral therapy poses logistical challenges for nursing and care staff. A non-oral solution for patients with dysphagia (chewing/swallowing difficulties), a common complication among elderly and neurologically impaired individuals. Expanding into Huntington’s Disease Chorea: A High Need Secondary Indication Serina also plans to explore development of POZ-VMAT2i for chorea associated with Huntington’s disease, a neurodegenerative disorder marked by progressive movement impairment and often, serious swallowing difficulties. A weekly injectable therapy may offer meaningful advantages over current oral options for this population and their caregivers. “POZ-VMAT2i embodies Serina’s commitment to solving real-world challenges for patients and caregivers who are often left behind by traditional therapies,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “By targeting non-compliant, institutionalized, and dysphagic patients with a transformative once-weekly injectable, we believe we can meaningfully expand access to proven VMAT2 inhibitor therapy and improve patient lives.” Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform™ provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology. The content above comes from the network. if any infringement, please contact us to modify.