Serina Therapeutics Parkinson’s trial clears safety review

Early blinded data from the first SER-252 dose cohort support advancing Serina Therapeutics’ Phase 1b registrational Parkinson’s study to higher doses.

Rhea-AI Filing Summary

Serina Therapeutics, Inc. (SER) reported initial blinded observations from Cohort 1 of its ongoing Phase 1b registrational study of SER-252 in patients with advanced Parkinson’s disease. An independent Safety Monitoring Committee completed its blinded safety and tolerability review and recommended that the study advance to Cohort 2, supporting continued dose escalation.

Cohort 1, which tested the lowest single dose of subcutaneous SER-252, showed a pharmacokinetic profile consistent with sustained apomorphine exposure and included sustained periods of motor-function improvement in individual patients on exploratory measures. The study will progress through ascending dose levels, and Serina expects topline data from the single-ascending-dose portion in the first half of 2027.

Positive

• Independent safety committee backs dose escalation after reviewing blinded Cohort 1 data, with pharmacokinetic and exploratory clinical observations supporting continued evaluation of SER-252 in advanced Parkinson’s disease.

Negative

• Going-concern risk highlighted in the forward-looking statements section, noting Serina’s ability to continue as a going concern as a key uncertainty alongside other development and regulatory risks.

Filing Explained

Although the company says the Cohort 1 observations support continued dose escalation, it also discloses that they are preliminary, blinded and exploratory in eight patients and may not evidence a treatment effect or predict later results.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Cohort 1 enrollment: 8 patients Randomization ratio: 3:1 SER-252 to placebo Single-ascending-dose cohorts: 5 cohorts of 8 (n=40) +3 more

6 metrics

Cohort 1 enrollment 8 patients Patients with Parkinson’s disease and motor fluctuations enrolled in Cohort 1 of the Phase 1b SER-252 study

Randomization ratio 3:1 SER-252 to placebo Allocation per cohort in the Phase 1b registrational SER-252 trial

Single-ascending-dose cohorts 5 cohorts of 8 (n=40) Planned single-ascending-dose component of the SER-252-1b study

Multiple-ascending-dose cohorts Up to 3 cohorts of 16 (n=48) Planned multiple-ascending-dose component of the SER-252-1b study

Topline data timing First half of 2027 Expected timing for topline results from the single-ascending-dose portion of the SER-252 study

Study geographies 4 countries SER-252 Phase 1b study sites in the U.S., Australia, South Korea and Taiwan

Key Terms

Independent Safety Monitoring Committee, single-ascending-dose, multiple-ascending-dose, continuous dopaminergic stimulation, +2 more

6 terms

Independent Safety Monitoring Committee medical

"the independent Safety Monitoring Committee (SMC) has completed its blinded review"

single-ascending-dose medical

"Cohort 1 evaluated the lowest dose level in the single-ascending-dose portion"

A single-ascending-dose (SAD) study is an early-stage clinical trial where small groups of volunteers each receive one single dose of a drug or treatment, with later groups given progressively higher doses to assess safety, tolerability and how the body handles the compound. Think of it as testing one scoop at a time to see how people react before increasing the amount. For investors, SAD results provide first human data on safety and dosing that inform development risk and next steps.

multiple-ascending-dose medical

"multiple-ascending-dose components (up to three cohorts of sixteen; n=48)"

A multiple-ascending-dose (MAD) study is a type of clinical trial where groups of volunteers take the same drug repeatedly while subsequent groups receive progressively higher doses, to track how the drug builds up in the body and whether side effects emerge or worsen over time. For investors it matters because MAD results set safe and effective dose ranges, reveal early safety and drug‑behavior signals, and materially affect the likelihood and cost of later, larger trials—like slowly turning up the heat on a recipe to find the right balance without burning it.

continuous dopaminergic stimulation medical

"designed to provide continuous dopaminergic stimulation (CDS) via subcutaneous injection"

Continuous dopaminergic stimulation is a medical approach that delivers steady, sustained levels of dopamine or dopamine‑like medication to the brain—using long‑acting pills, patches, pumps, or implants—to avoid the highs and lows caused by intermittent dosing. For investors, it matters because therapies and devices built on this concept target more consistent symptom control and fewer treatment complications, which affects clinical trial outcomes, regulatory review, adoption by clinicians and patients, and the commercial potential of related products.

MDS-UPDRS medical

"exploratory clinical measures including MDS-UPDRS motor scores and structured assessments"

A clinician-rated scorecard used to measure the severity and progression of Parkinson’s disease symptoms, covering movement problems, daily activities and other related issues. Investors use changes in this score during clinical trials as a clear, standardized signal of a drug’s effectiveness—similar to a report card showing whether a treatment meaningfully improves patients’ lives, which can influence regulatory approval, market expectations and a company’s valuation.

registrational study medical

"ongoing Phase 1b registrational study of SER-252 in patients"

A registrational study is a late-stage clinical trial designed to give the government regulators the evidence they need to decide whether a drug, therapy, or medical device can be approved for sale. Think of it as the final exam or road test for a medical product: its results largely determine whether the product can reach the market, which directly affects potential revenue, company valuation, and investor risk.

FAQ

What did Serina Therapeutics (SER) announce about the SER-252 study?

Serina announced that an independent Safety Monitoring Committee completed a blinded review of Cohort 1 in its Phase 1b registrational SER-252 study and recommended advancing to Cohort 2, based on safety, tolerability and supportive pharmacokinetic and exploratory clinical observations.

What were the key blinded Cohort 1 observations for SER-252 in SER?

At the lowest dose tested, blinded Cohort 1 observations showed a pharmacokinetic profile consistent with sustained apomorphine exposure and included sustained periods of improved motor function in individual patients on exploratory clinical assessments, alongside safety and tolerability findings that supported escalation to the next dose level.

How is Serina Therapeutics’ SER-252 Phase 1b registrational study designed?

The SER-252-1b trial is randomized, double-blind and placebo-controlled, with a single-ascending-dose component of five cohorts of eight patients (n=40) and a multiple-ascending-dose component of up to three cohorts of sixteen patients (n=48), evaluating safety, tolerability, pharmacokinetics and exploratory efficacy measures.

When does Serina Therapeutics (SER) expect topline data from SER-252?

Serina expects to report topline data from the single-ascending-dose portion of the SER-252 Phase 1b registrational study in the first half of 2027, following progression through planned ascending dose cohorts overseen by the independent Safety Monitoring Committee.

What is SER-252 and how is it intended to help advanced Parkinson’s patients?

SER-252 is an investigational, long-acting subcutaneous formulation of apomorphine enabled by Serina’s POZ technology, designed to provide continuous dopaminergic stimulation, aiming for more consistent motor control while reducing the treatment burden associated with existing continuous infusion approaches in advanced Parkinson’s disease.

What key risks does Serina Therapeutics (SER) highlight in this update?

Serina notes that Cohort 1 data are preliminary, blinded, exploratory and from a small patient group and cites significant risks, including development and regulatory uncertainties and Serina’s ability to continue as a going concern, as discussed further in its prior SEC filings.

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Available on EDGAR 09/09/2026 - 07:43 AM Accepted by SEC EDGAR 09/09/2026 - 07:43 AM Learn about SEC filing dates

0001708599false00017085992026-09-092026-09-09

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): September 9, 2026

Serina Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

1-38519

82-1436829

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

601 Genome Way, Suite 2001

Huntsville, Alabama 35806

(Address of principal executive offices)

(256) 327-9630

(Registrant’s telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of exchange on which registered

Common Stock, par value $0.0001 per share

SER

NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 Other Items.

On September 9, 2026, the Company issued a press release announcing that the Independent Safety Monitoring Committee has completed its blinded review of Cohort 1 of the Company's ongoing Phase 1b registrational study of SER-252 in patients with advanced Parkinson's disease and has recommended that the study advance to Cohort 2. Cohort 1, which evaluated the lowest dose in the single-ascending-dose portion of the study, showed a pharmacokinetic profile consistent with the sustained apomorphine exposure SER-252 is designed to provide, along with sustained periods of improvement in motor function in individual patients on exploratory clinical measures. The Company expects to report topline data from the single-ascending-dose portion of the study in the first half of 2027. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01 - Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press Release, dated September 9, 2026, reporting Cohort 1 Observations from SER-252 Registrational Study in Advanced Parkinson’s Disease and Advances to Cohort 2
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			SERINA THERAPEUTICS, INC.
Date: September 9, 2026			By:			/s/ Steve Ledger
						Chief Executive Officer

Serina Therapeutics Reports Cohort 1 Observations from SER-252 Registrational Study in Advanced Parkinson’s Disease and Advances to Cohort 2

- Independent Safety Monitoring Committee recommends advancement to Cohort 2 following blinded review of Cohort 1 safety and tolerability data –

- Pharmacokinetic observations at the lowest dose evaluated were consistent with the sustained apomorphine exposure SER-252 is designed to provide –

- Blinded Cohort 1 observations included sustained periods of improvement in motor function in individual patients on exploratory clinical measures –

- Serina expects to report topline data from the single-ascending-dose portion of the study in the first half of 2027 -

HUNTSVILLE, Ala., September 9, 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 that the independent Safety Monitoring Committee (SMC) has completed its blinded review of Cohort 1 of the ongoing Phase 1b registrational study of SER-252 in patients with advanced Parkinson’s disease and recommended that the study advance to Cohort 2.

Cohort 1 evaluated the lowest dose level in the single-ascending-dose portion of the study. In addition to supporting continued dose escalation, blinded Cohort 1 observations showed a pharmacokinetic profile consistent with the sustained apomorphine exposure SER-252 is designed to provide and included sustained periods of improvement in motor function in individual patients on exploratory clinical measures.

The SMC's recommendation to advance was based on its review of blinded safety and tolerability data from Cohort 1. Considered together with the blinded pharmacokinetic, safety and exploratory clinical observations, these results support continued evaluation through the planned dose-escalation study.

“These initial observations strengthen our confidence in SER-252 and are consistent with the profile the program was designed to achieve,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “At the lowest dose evaluated, we observed the sustained pharmacokinetic profile SER-252 was engineered to achieve, together with encouraging clinical observations in a study designed to provide an assessment of treatment effect. Importantly, the independent Safety Monitoring Committee has recommended that we proceed with dose escalation, giving us a clear path into Cohort 2 while preserving the integrity of the blinded study.”

Mr. Ledger continued, “Patients with advanced Parkinson’s disease can reach a point where oral medications no longer provide predictable control of motor symptoms, leaving them with increasingly disruptive periods of ‘OFF’ time and limited treatment options. Apomorphine is a well-established and potent dopaminergic therapy, but available approaches for sustained delivery can impose a significant treatment burden. SER-252 is designed to provide sustained apomorphine exposure through a convenient, long-acting subcutaneous treatment, with the potential to offer a differentiated next-generation option for these patients.”

Cohort 1 Observations and Study Progression

Cohort 1 enrolled eight patients with Parkinson’s disease and motor fluctuations in the randomized, double-blind, placebo-controlled study. Patients in each cohort are randomized 3:1 to receive a single dose of SER-252 or placebo, with each successive cohort evaluating a higher dose of SER-252.

The study is designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous SER-252, with exploratory clinical measures including MDS-UPDRS motor scores and structured assessments of patient motor state.

During Cohort 1, patients were withdrawn from background Parkinson’s medications in accordance with the study protocol, allowing investigators to characterize the pharmacokinetic profile and observe changes in motor function with limited contribution from concomitant dopaminergic therapy.

At the starting dose, blinded observations included:

•a sustained pharmacokinetic profile consistent with prolonged apomorphine exposure;

•sustained periods of improvement in motor function in individual patients on exploratory clinical assessments; and

•safety and tolerability findings that supported the SMC’s recommendation to advance to the next dose level.

The Company is now advancing SER-252 into Cohort 2 and will continue to evaluate safety, tolerability, pharmacokinetics and exploratory measures of clinical activity across ascending dose levels. Serina expects to report topline data from the single-ascending-dose portion of the study in the first half of 2027.

Addressing a Significant Need in Advanced Parkinson’s Disease

As Parkinson’s disease progresses, many patients experience increasingly unpredictable motor fluctuations as the duration of benefit from individual doses of oral levodopa shortens. For patients whose symptoms can no longer be adequately controlled with conventional oral therapy, more intensive treatment approaches may be required to provide sustained dopaminergic stimulation.

SER-252 is an investigational, long-acting formulation of apomorphine enabled by Serina’s proprietary POZ technology. It is designed to provide continuous dopaminergic stimulation (CDS) via subcutaneous injection with the goal of providing more consistent motor control while reducing the administration burden associated with existing continuous infusion approaches. CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Serina believes this profile could differentiate SER-252 from existing continuous infusion approaches and support its potential as a next-generation, device-assisted treatment option for patients with advanced Parkinson’s disease.

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 will be conducted across sites in the U.S., Australia, South Korea, and Taiwan.

For more information, please visit https://serinatx.com.

Cautionary Statement Regarding Forward-Looking Statements

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 fact that the Cohort 1 data described in this release are preliminary, blinded, and exploratory, and involve a small number of patients, and therefore may not be evidence of treatment effect or predictive of future results; 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

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 17.8 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 23.2 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 13.3 KB