Serina Therapeutics Draws First $5 Million Funding Tranche to Support Registrational Trial of SER-252 in Parkinson’s Disease
Serina Therapeutics (NYSE: SER) drew the first $5 million tranche under a financing agreement that can provide up to $20 million tied to development milestones. The company submitted an IND to the FDA and received a first HREC approval in Australia.
Serina remains on track to initiate a registrational Phase 1b study of SER-252 in Q4 2025 with first patient dosing expected before year‑end. The SER-252-1b trial is randomized, double‑blind, placebo‑controlled with single‑ascending‑dose (five cohorts of eight; n=40) and multiple‑ascending‑dose components (up to three cohorts of 16; n=48), evaluating safety, tolerability, and pharmacokinetics, plus exploratory MDS‑UPDRS motor assessments across U.S. and Australian sites.
Serina Therapeutics (NYSE: SER) ha prelevato la prima tranche da 5 milioni di dollari ai sensi di un accordo di finanziamento che può fornire fino a 20 milioni di dollari legati a traguardi di sviluppo. L'azienda ha presentato un IND alla FDA e ha ottenuto una prima approvazione HREC in Australia.
Serina rimane in linea per avviare uno studio di fase 1b di registrazione di SER-252 nel quarto trimestre del 2025 con la prima somministrazione prevista prima della fine dell'anno. Lo studio SER-252-1b è randomizzato, doppio cieco, controllato con placebo, con dosi singole ascendenti (cinque coorti da otto; n=40) e componenti a dosi ascendenti multiple (fino a tre coorti da 16; n=48), valutando sicurezza, tollerabilità e farmacocinetica, oltre a valutazioni motorie esplorative MDS-UPDRS nei siti degli Stati Uniti e in Australia.
Serina Therapeutics (NYSE: SER) obtuvo la primera tracha de $5 millones conforme a un acuerdo de financiamiento que puede proporcionar hasta $20 millones vinculados a hitos de desarrollo. La compañía presentó una IND ante la FDA y recibió la primera aprobación de HREC en Australia.
Serina continúa en camino de iniciar un estudio de fase 1b de registro de SER-252 en el cuarto trimestre de 2025 con la primera dosificación prevista antes de fin de año. El ensayo SER-252-1b es aleatorizado, doble ciego, controlado con placebo, con dosis únicas ascendentes (cinco cohortes de ocho; n=40) y componentes de dosis ascendentes múltiples (hasta tres cohortes de 16; n=48), evaluando seguridad, tolerabilidad y farmacocinética, además de evaluaciones exploratorias motoras MDS-UPDRS en sitios de EE. UU. y Australia.
Serina Therapeutics (NYSE: SER)가 개발 이정표에 연계된 최대 2천만 달러를 제공할 수 있는 자금 조달 계약에 따라 처음 분기 500만 달러를 인출했습니다. 회사는 FDA에 IND를 제출했고 호주에서 최초의 HREC 승인을 받았습니다.
Serina는 SER-252의 등록용 1b상 시험을 2025년 4분기에 시작할 예정이며 연말 이전에 첫 투여가 예상됩니다. SER-252-1b 시험은 무작위로 진행되며 이중 맹검, 위약 대조이며 단일 상승 용량(dose-escalating)으로 5개 코호트 각각 8명(n=40), 다중 상승 용량 구성(최대 3개 코호트 16명; n=48)으로 구성되어 안전성, 내약성, 약물동태를 평가하고 미국 및 호주 사이트에서 Exploratory MDS-UPDRS 모터 평가를 진행합니다.
Serina Therapeutics (NYSE: SER) a prélevé la première tranche de 5 millions de dollars dans le cadre d'un accord de financement pouvant fournir jusqu'à 20 millions de dollars liés à des étapes de développement. La société a soumis un IND à la FDA et a reçu une première approbation HREC en Australie.
Serina reste sur la bonne voie pour lancer une étude de phase 1b de registre de SER-252 au T4 2025 avec une première administration attendue avant la fin de l'année. L'essai SER-252-1b est randomisé, en double aveugle, contrôlé par placebo, avec des doses uniques croissantes (cinq cohortes de huit; n=40) et des composants à doses croisées multiples (jusqu'à trois cohortes de 16; n=48), évaluant la sécurité, la tolérance et la pharmacocinétique, ainsi que des évaluations exploratoires moteurs MDS-UPDRS sur les sites américains et australiens.
Serina Therapeutics (NYSE: SER) entnahm die erste Tranche von 5 Millionen USD aus einer Finanzierung, die bis zu 20 Millionen USD entsprechend Meilensteinen der Entwicklung bereitstellen kann. Das Unternehmen reichte eine IND bei der FDA ein und erhielt die erste HREC-Zustimmung in Australien.
Serina bleibt auf Kurs, um im vierten Quartal 2025 eine registrierungssorientierte Phase-1b-Studie von SER-252 zu initiieren mit erstem Patienteneinsatz voraussichtlich vor Jahresende. DieSER-252-1b-Studie ist randomisiert, doppelblind, placebo-kontrolliert mit einzelstufigen aufsteigenden Dosen (fünf Kohorten zu acht; n=40) und Komponenten mit mehrstufigen Dosen (bis zu drei Kohorten mit 16; n=48), und bewertet Sicherheit, Verträglichkeit und Pharmakokinetik sowie explorative motorische MDS-UPDRS-Bewertungen an Standorten in den USA und Australien.
Serina Therapeutics (NYSE: SER) سحبت الشرائح الأولى من تمويل بقيمة 5 ملايين دولار يمكن أن يوفر حتى 20 مليون دولار مرتبطة بمعالم التطوير. قدمت الشركة IND إلى FDA وتلقت الموافقة الأولى لـ HREC في أستراليا.
لا تزال سيرينا في الطريق لبدء دراسة تسجيلية من المرحلة 1b لـ SER-252 في الربع الرابع من 2025 مع إعطاء جرعة أولية متوقعة قبل نهاية السنة. تجربة SER-252-1b عشوائية، مزدوجة التعمية، محكومة بالدواء الوهمي، مع جرعات وحيدة تصاعدية (خمسة طُواف من ثمانية؛ لعدد ع samples=40) ومكونات جرعات تصاعدية متعددة (حتى ثلاثة طُواف من 16؛ n=48)، تقيم السلامة والتحمل والدواء الحركي، بالإضافة إلى تقييمات حركية استكشافية لـ MDS-UPDRS عبر مواقع في الولايات المتحدة وأستراليا.
Serina Therapeutics (NYSE: SER) 已按照一项融资协议从初次阶段获得第一笔< b>500万美元的拨款，该协议最多可提供到< b>2000万美元，与研发里程碑相关。公司已向FDA提交< b>IND，并在澳大利亚获得第一项< b>HREC批准。
Serina 仍在按计划推进，在< b>2025年第四季度启用 SER-252 的注册性1b期研究，预计在年末前完成首例给药。SER-252-1b 试验为随机、双盲、安慰剂对照，采用单次递增剂量（五组，每组8名，共40名；n=40）以及多次递增剂量组分（最多三组，每组16名；n=48），评估安全性、耐受性和药代动力学，并在美国和澳大利亚站点进行探索性MDS-UPDRS运动评分的评估。
- $5.0M initial tranche drawn under up to $20M financing
- IND submitted to FDA and HREC approval obtained in Australia
- Planned registrational Phase 1b study start targeted in Q4 2025
- First patient dosing expected before end of 2025
- Subsequent financing tranches conditional on defined milestones
- Planned registrational cohort totals n=88, a limited sample for broad efficacy readouts
Insights
Serina secured
The drawdown of the initial
Key dependencies and risks include successful patient enrollment, dose-escalation safety decisions by the Safety Review Committee, and achievement of development milestones required to access remaining tranches. The financing is milestone-driven, so delays in enrollment or safety issues would directly affect future funding. Operational execution across two countries adds logistical complexity.
Concrete items to watch in the near term are initiation of site activation and first patient dosing targeted before the end of
$5 million tranche received under up to$20 million financing agreement- IND submitted to FDA and HREC approval obtained in Australia; global trial initiation in Q4 2025
HUNTSVILLE, AL, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the drawdown of the first
The initial tranche was received in accordance with the terms of the agreement. Subsequent tranches are tied to achievement of defined development milestones, including patient enrollment in the planned clinical trial.
“The financing milestone provides the resources to advance SER-252 into the planned registrational trial, marking an important step toward addressing the unmet needs of those with advanced Parkinson’s disease,”, said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “We are pleased to have filed the IND and to be progressing on schedule toward initiating the study in the current quarter.”
Serina has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and received its first Human Research Ethics Committee (HREC) approval in Australia for SER-252. 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.
SER-252 Registrational Study Design Overview
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. The registrational study is designed to evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation will be overseen by a Safety Review Committee and the study will be conducted across sites in the U.S. and Australia.
About SER-252 (POZ-apomorphine)
SER 252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection. CDS has been shown to reduce the severity of motor fluctuations (which includes levodopa-induced dyskinesia) and enable greater daily on time, with reduced off time, in advanced Parkinson’s patients. SER-252 leverages strategic partner Enable Injections’ enFuse™ wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection.
About Serina Therapeutics
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. For more information, please visit https://serinatx.com.
For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630
FAQ
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