Serina Therapeutics Announces First Patient Enrolled in Phase 1b Registrational Trial of SER-252 for Advanced Parkinson's Disease
Rhea-AI Summary
Serina Therapeutics (NYSE American: SER) announced the first patient enrollment in its Phase 1b registrational trial of SER-252 for advanced Parkinson's disease in Australia on Feb 19, 2026. The study will assess safety, tolerability, pharmacokinetics and preliminary efficacy.
The company said it remains on track to begin dosing in Q1 2026 and cited FDA alignment on a 505(b)(2) NDA pathway. Serina noted operational partnerships with Parkinson's Australia and Neuroscience Trials Australia to support enrollment.
Positive
- First patient enrolled in Phase 1b registrational trial for SER-252
- FDA alignment on a 505(b)(2) registrational development pathway
- Australian operational presence and partnerships to support efficient enrollment
Negative
- No efficacy data yet—trial is designed to collect preliminary efficacy among other endpoints
- Enrollment and dosing timelines remain subject to typical clinical trial and operational risks
Key Figures
Market Reality Check
Peers on Argus
SER gained 1.82% while peers were mixed: VTVT -0.56%, JUNS -0.18%, PYPD -3.63%, but RLMD +11.78% and MAIA +9.47%. Moves do not show a unified sector direction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 03 | Investor webinar | Neutral | +1.5% | Announcement of CEO presentation and Q&A on FDA-era strategic priorities. |
| Jan 28 | IND clearance | Positive | -0.7% | FDA cleared IND for SER-252 enabling Phase 1b registrational study start-up. |
| Jan 15 | Listing deficiency | Negative | +0.8% | NYSE notice over low stockholders’ equity and multi-year losses, triggering cure plan. |
| Dec 11 | Leadership hire | Positive | -2.2% | Appointment of VP, Head of Chemistry to support POZ-based candidates including SER-252. |
| Dec 10 | Hold response | Positive | -3.0% | Submission of complete response to FDA full clinical hold on SER-252 with revised protocol. |
Positive or strategic news has often seen muted or negative next‑day moves, while clearly negative regulatory/listing news has not reliably sold off.
Over the last few months, Serina has moved SER-252 from an FDA clinical hold response on Dec 10, 2025 toward IND clearance on Jan 28, 2026, and now to first patient enrollment in this Phase 1b registrational study. Alongside these clinical steps, the company received an NYSE deficiency notice tied to low shareholders’ equity and has been strengthening its leadership team. Recent news often showed price reactions that diverged from the apparent tone of announcements.
Regulatory & Risk Context
An effective S-3 filed on 2026-01-30 registers 7,722,006 shares for resale tied to a 2025 senior unsecured convertible note and warrants. The note provides up to $20 million of funding at 10% interest with conversion at $5.18 per share and warrants at $5.44. The company highlights going‑concern doubts, NYSE equity deficiencies, and early-stage clinical risk.
Market Pulse Summary
This announcement marks a key operational milestone as the first patient enters Serina’s Phase 1b registrational trial of SER-252 for advanced Parkinson’s disease, following FDA IND clearance on Jan 28, 2026. It progresses the 505(b)(2) NDA strategy but sits against a backdrop of NYSE equity deficiencies (equity of $1.6 million) and an effective S-3 registering 7,722,006 resale shares linked to a $20 million convertible note, all of which frame the company’s risk profile.
Key Terms
phase 1b medical
pharmacokinetics medical
505(b)(2) nda pathway regulatory
AI-generated analysis. Not financial advice.
- 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
sriley@serinatherapeutics.com
(256) 327-9630
FAQ
What did Serina (SER) announce on February 19, 2026 about SER-252 enrollment?
When does Serina expect to begin dosing patients in the SER-252 Phase 1b trial (SER)?
What is the regulatory pathway for SER-252 that Serina (SER) reported?
How is Serina supporting enrollment for the SER-252 registrational trial (SER)?
What endpoints will the Phase 1b registrational study of SER-252 (SER) evaluate?
What does first patient enrollment mean for investors following Serina's (SER) update?
