Form 8-K
8-K — Serina Therapeutics, Inc.
Accession: 0001708599-26-000054
Filed: 2026-09-09
Period: 2026-09-09
CIK: 0001708599
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — ser-20260909.htm (Primary)
EX-99.1 (cohort1pr09032026_sredits.htm)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
8-K (Primary)
Filename: ser-20260909.htm · Sequence: 1
ser-20260909
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
EX-99.1
EX-99.1
Filename: cohort1pr09032026_sredits.htm · Sequence: 2
Document
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
XML — IDEA: XBRL DOCUMENT
XML
Filename: R1.htm · Sequence: 7
v3.26.1
Cover
Sep. 09, 2026
Cover [Abstract]
Document Type
8-K
Document Period End Date
Sep. 09, 2026
Entity Registrant Name
Serina Therapeutics, Inc.
Entity Incorporation, State or Country Code
DE
Entity File Number
1-38519
Entity Tax Identification Number
82-1436829
Entity Address, Address Line One
601 Genome Way
Entity Address, Address Line Two
Suite 2001
Entity Address, City or Town
Huntsville
Entity Address, State or Province
AL
Entity Address, Postal Zip Code
35806
City Area Code
(256)
Local Phone Number
327-9630
Written Communications
false
Soliciting Material
false
Pre-commencement Tender Offer
false
Pre-commencement Issuer Tender Offer
false
Title of 12(b) Security
Common Stock, par value $0.0001 per share
Trading Symbol
SE
Security Exchange Name
NYSEAMER
Entity Emerging Growth Company
false
Entity Central Index Key
0001708599
Amendment Flag
false
X
- Definition
Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
No definition available.
+ Details
Name:
dei_AmendmentFlag
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Area code of city
+ References
No definition available.
+ Details
Name:
dei_CityAreaCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Cover page.
+ References
No definition available.
+ Details
Name:
dei_CoverAbstract
Namespace Prefix:
dei_
Data Type:
xbrli:stringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
No definition available.
+ Details
Name:
dei_DocumentPeriodEndDate
Namespace Prefix:
dei_
Data Type:
xbrli:dateItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
No definition available.
+ Details
Name:
dei_DocumentType
Namespace Prefix:
dei_
Data Type:
dei:submissionTypeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Address Line 1 such as Attn, Building Name, Street Name
+ References
No definition available.
+ Details
Name:
dei_EntityAddressAddressLine1
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Address Line 2 such as Street or Suite number
+ References
No definition available.
+ Details
Name:
dei_EntityAddressAddressLine2
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the City or Town
+ References
No definition available.
+ Details
Name:
dei_EntityAddressCityOrTown
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Code for the postal or zip code
+ References
No definition available.
+ Details
Name:
dei_EntityAddressPostalZipCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the state or province.
+ References
No definition available.
+ Details
Name:
dei_EntityAddressStateOrProvince
Namespace Prefix:
dei_
Data Type:
dei:stateOrProvinceItemType
Balance Type:
na
Period Type:
duration
X
- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityCentralIndexKey
Namespace Prefix:
dei_
Data Type:
dei:centralIndexKeyItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Indicate if registrant meets the emerging growth company criteria.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityEmergingGrowthCompany
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
No definition available.
+ Details
Name:
dei_EntityFileNumber
Namespace Prefix:
dei_
Data Type:
dei:fileNumberItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Two-character EDGAR code representing the state or country of incorporation.
+ References
No definition available.
+ Details
Name:
dei_EntityIncorporationStateCountryCode
Namespace Prefix:
dei_
Data Type:
dei:edgarStateCountryItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityRegistrantName
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityTaxIdentificationNumber
Namespace Prefix:
dei_
Data Type:
dei:employerIdItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Local phone number for entity.
+ References
No definition available.
+ Details
Name:
dei_LocalPhoneNumber
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
Name:
dei_PreCommencementIssuerTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
+ Details
Name:
dei_PreCommencementTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
+ Details
Name:
dei_Security12bTitle
Namespace Prefix:
dei_
Data Type:
dei:securityTitleItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
Namespace Prefix:
dei_
Data Type:
dei:edgarExchangeCodeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
Name:
dei_SolicitingMaterial
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
dei_
Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration