Serina Therapeutics Announces Dosing of First Patient in Phase 1b Registrational Trial of SER-252 for Advanced Parkinson’s Disease
Rhea-AI Summary
Serina Therapeutics (NYSE: SER) has dosed the first patient in a Phase 1b registrational trial of SER-252 for advanced Parkinson's disease. The study will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy and is aligned with an FDA 505(b)(2) NDA pathway.
Serina expects a blinded Safety Monitoring Committee review from Cohort 1 enabling advancement to Cohort 2 in 3Q 2026 and will provide ongoing clinical and operational updates as enrollment progresses.
Positive
- First patient dosed in Phase 1b registrational trial
- FDA alignment on 505(b)(2) NDA pathway
- Planned blinded Safety Monitoring Committee review in 3Q 2026
Negative
- No efficacy results available; only initial safety/tolerability data expected
- Advancement timeline dependent on blinded review from Cohort 1
Key Figures
Market Reality Check
Peers on Argus
SER was down 3.09% while several biotech peers were positive (e.g., MAIA +6.4%, JUNS +4%, VTVT +3.28%), indicating stock-specific trading despite today’s trial update.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 19 | Trial enrollment start | Positive | -0.9% | First patient enrolled in Phase 1b SER-252 trial for advanced Parkinson’s. |
| Feb 03 | Investor webinar | Neutral | +1.5% | Announcement of CEO presentation and Q&A on FDA-related strategic priorities. |
| Jan 28 | IND clearance | Positive | -0.7% | FDA cleared IND for SER-252 enabling planned Phase 1b registrational study. |
| Jan 15 | NYSE deficiency notice | Negative | +0.8% | NYSE deficiency notification over low stockholders’ equity and recent losses. |
| Dec 11 | Leadership appointment | Positive | -2.2% | Appointment of VP, Head of Chemistry to support POZ-based candidate development. |
Recent positive regulatory and clinical milestones for SER-252 have often been met with small negative or modest price reactions.
Over the last few months, Serina has advanced SER-252 through key steps: FDA IND clearance on Jan 28, 2026, first patient enrollment on Feb 19, 2026, and now first dosing in the Phase 1b registrational trial. Alongside this, the company addressed NYSE listing deficiencies and strengthened its chemistry leadership. Historically, these positive clinical and regulatory updates have produced modest, sometimes negative, 24-hour price reactions, underscoring cautious market sentiment around the program and the company’s financial position.
Regulatory & Risk Context
An effective S-3 from Jan 30, 2026 registers 7,722,006 shares for resale tied to a 2025 senior unsecured convertible note and warrants. While Serina receives no proceeds from resales, the note provides up to $20,000,000 of funding at 10% interest, convertible at $5.18 with warrants exercisable at $5.44. The filing highlights going-concern risks, NYSE equity deficiencies, and early-stage clinical uncertainty.
Market Pulse Summary
This announcement marks the first patient dosed in Serina’s Phase 1b registrational SER-252 trial for advanced Parkinson’s disease, building on recent IND clearance and enrollment progress. The study targets patients inadequately controlled by current therapies and plans a blinded Cohort 1 safety review in 3Q 2026. Historically, similar milestones have produced limited price impact, while NYSE listing deficiencies and going-concern language remain important context. Investors may track enrollment pace, safety findings, and regulatory or financing updates.
Key Terms
phase 1b medical
registrational medical
pharmacokinetics medical
safety monitoring committee medical
505(b)(2) nda pathway regulatory
AI-generated analysis. Not financial advice.
- Blinded evaluation of safety and tolerability data by the Safety Monitoring Committee from Cohort 1 and advancement to Cohort 2 is expected in 3Q 2026 –
- Advancement reflects continued execution of capital-efficient development strategy leveraging POZ Platform™ -
HUNTSVILLE, AL, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. ("Serina" or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing drug candidates enabled by its proprietary POZ Platform™ drug optimization technology, today announced that it has dosed the first patient in its Phase 1b registrational clinical trial evaluating SER-252 in patients with advanced Parkinson's disease.
The Phase 1b registrational study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SER-252 in patients with advanced Parkinson’s disease whose symptoms are inadequately controlled by current standard-of-care therapies. Serina anticipates that blinded review of safety and tolerability by the Safety Monitoring Committee from Cohort 1 will allow advancement to Cohort 2 in the third quarter of 2026.
“Dosing the first patient represents an important inflection point for Serina as we begin generating clinical data with SER-252,” said Steve Ledger, Chief Executive Officer of Serina. "With FDA alignment on our 505(b)(2) NDA pathway and recognition of this Phase 1b trial as registrational, we are positioned to efficiently generate the clinical data necessary to bring SER-252 to market. We are grateful to our clinical investigators, the Parkinson's community in Australia, and the patients who are making this trial possible."
Serina has established relationships with Parkinson's Australia and Neuroscience Trials Australia to support patient identification and enrollment activities. The Company plans to provide further updates on the trial as patient enrollment progresses.
Initial dosing activities are underway at global clinical sites, including Australia, where Serina has established strong investigator relationships to support efficient trial execution. The Company expects to provide additional clinical and operational updates as the study advances.
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.
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.
Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of federal securities laws. All statements that are not historical fact, including statements about Serina's planned clinical programs, including timing for patient enrollment and dosing, the potential of Serina's POZ polymer technology, and the Company's ability to advance its clinical trial, are forward-looking statements 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. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change.
Actual results may differ materially from those projected in such statements due to a variety of important factors including, 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 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, 2024, 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 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
FAQ
What milestone did Serina Therapeutics (SER) announce on February 24, 2026?
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When does Serina expect the Safety Monitoring Committee review for the SER-252 trial (SER)?
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