Serina Therapeutics Announces Completion of Enrollment and Dosing in Cohort 1 of Registrational Trial of SER-252 for Advanced Parkinson’s Disease
Rhea-AI Summary
Serina Therapeutics (NYSE American: SER) reported completion of enrollment and dosing of all eight patients in Cohort 1 of its ongoing Phase 1b registrational trial of SER-252 for advanced Parkinson’s disease, ahead of prior guidance to finish by the end of the third quarter of 2026.
The randomized, double-blind, placebo-controlled study includes single-ascending-dose (five cohorts of eight, n=40) and multiple-ascending-dose parts (up to three cohorts of sixteen, n=48) to assess safety, tolerability and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures such as MDS-UPDRS motor scores. An independent Safety Monitoring Committee will now conduct a blinded review of Cohort 1 data to inform the next dose-escalation step. Trial sites are in the United States and Australia, with plans to add locations in South Korea and Taiwan.
Positive
- Cohort 1 enrollment and dosing completed ahead of Q3 2026 guidance
- Phase 1b registrational design includes up to 88 patients across SAD and MAD
- Independent Safety Monitoring Committee overseeing blinded dose-escalation decisions
- Multinational trial footprint in U.S. and Australia with planned expansion to Asia
Negative
- None.
Market reaction after Phase 1b enrollment milestone: SER -3.69% in the Jul 23 session
In the Jul 23 session, SER declined 3.69%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 09 | Cohort dosing milestone | Positive | +10.0% | Completed sentinel dosing and received committee recommendation to continue dosing |
| May 14 | First-quarter earnings | Negative | -4.7% | Reported operating expenses, net loss, and ongoing clinical development costs |
| Apr 07 | LNP presentation | Negative | -3.3% | Presentation included a rat study that failed to elicit an antibody response |
| Apr 02 | Listing compliance | Positive | +1.4% | NYSE American accepted the compliance plan and granted a cure period |
| Mar 25 | Full-year earnings | Negative | -13.9% | Reported annual net loss and year-end cash alongside clinical progress |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Historical reactions were directionally aligned with the classified tone across the five selected events, including a 10% rise after the July 9 cohort milestone and a 13.86% decline after the March 25 earnings release.
Key Terms
pharmacokinetics medical
placebo-controlled medical
single-ascending-dose medical
multiple-ascending-dose medical
double-blind medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- All eight patients enrolled and dosed in Cohort 1 ahead of previously disclosed guidance of the end of the third quarter of 2026 -
- Independent Safety Monitoring Committee to review Cohort 1 safety and tolerability in accordance with the study protocol -
- Company expects to provide a further update following completion of the Safety Monitoring Committee review –
HUNTSVILLE, Ala., July 23, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the completion of enrollment and dosing in Cohort 1 of its ongoing Phase 1b registrational clinical trial evaluating SER-252 in patients with advanced Parkinson’s disease.
All eight patients in Cohort 1 have now been dosed across clinical sites in the United States and Australia. The milestone was achieved ahead of the Company’s previously disclosed guidance to complete Cohort 1 enrollment and dosing by the end of the third quarter of 2026.
“Earlier this month, we shared we expected to complete Cohort 1 ahead of our prior end-of-third-quarter guidance, and today we have delivered that milestone,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “The progression from sentinel group review to completion of dosing reflects strong execution by our clinical sites and study team. We are grateful to the patients and investigators participating in the study and look forward to the independent Safety Monitoring Committee’s review, which will inform the next dose-escalation decision.”
The independent Safety Monitoring Committee is expected to perform a blinded review of available Cohort 1 safety and tolerability observations in accordance with the study protocol. Following completion of that review, Serina expects to determine the next dose-escalation step and provide a further update on the clinical program.
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 an independent Safety Monitoring Committee, and the study is being conducted across sites in the United States and Australia with plans to bring on additional sites in South Korea and Taiwan.
About the POZ Platform™
Serina’s proprietary POZ technology is based on a synthetic, water-soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.
Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.
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). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Preclinical studies support the potential of SER 252 to provide CDS without skin reactions.
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.
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These statements are based on management’s current expectations, plans, beliefs, or forecasts for the future, and are subject to uncertainty and changes in circumstances. The facts and assumptions underlying these statements may change, and undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made. Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” "targeting," “expects,” or “estimates”) should be considered to be forward-looking statement, including statements about the potential of Serina’s POZ polymer technology, Serina’s estimates regarding future revenue, expenses, capital requirements and need for additional financing, and Serina’s planned clinical programs, including planned clinical trials. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory holds, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; Serina’s ability to continue as a going concern; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the company’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and, except as required by law, Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630
