- First patient successfully enrolled in global registrational study in Australia
- Operational presence in Australia positions Serina to advance enrollment in Cohort 1
- Company remains on track for first patient dosing in the first quarter of 2026

HUNTSVILLE, AL, Feb. 19, 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 the first patient has been enrolled in the Company's Phase 1b registrational 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 remains on track to initiate dosing during the current quarter, consistent with previously disclosed guidance.

"Enrolling our first patient represents an important operational milestone as we advance SER-252 into the clinic," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. "Our team has built a strong operational presence in Australia, working closely with leading Parkinson's disease specialists and patient advocacy organizations to support efficient enrollment. With FDA alignment on our registrational development strategy under a 505(b)(2) NDA pathway, we are focused on executing this trial and generating meaningful clinical data for patients with advanced Parkinson's disease who face significant unmet medical needs."

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.

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
[email protected]
(256) 327-9630