FDA clears Serina Therapeutics (SER) IND for SER-252 in advanced Parkinson’s

Rhea-AI Filing Summary

Serina Therapeutics, Inc. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson’s disease. This clearance permits the company to move forward with regulatory and site-level preparations.

The IND enables Serina to begin a planned Phase 1b registrational clinical study of SER-252 in patients with advanced Parkinson’s disease, a stage aimed at generating data that could ultimately support a future marketing application if successful.

Positive

• FDA IND clearance for SER-252 allows Serina Therapeutics to initiate a planned Phase 1b registrational clinical study in advanced Parkinson’s disease, a potentially transformative regulatory milestone for the company’s pipeline.

Negative

• None.

Insights

Biopharma regulatory and clinical strategy analyst

FDA IND clearance for SER-252 is a key step toward a registrational trial in advanced Parkinson’s disease.

Serina Therapeutics obtained FDA clearance of its IND application for SER-252, an investigational therapy for advanced Parkinson’s disease. IND clearance is required before testing a new drug in humans and reflects FDA’s agreement that the proposed clinical plan can proceed.

The company plans a Phase 1b registrational clinical study, suggesting the design may support eventual approval if safety and efficacy data are strong. Because the excerpt does not provide enrollment size, endpoints, or timelines, the eventual impact will depend on how the study is executed and what results emerge.

Future company disclosures describing the Phase 1b trial’s start, patient population details, and early safety or efficacy observations will be important in understanding how SER-252 might progress within the advanced Parkinson’s disease treatment landscape.

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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): January 27, 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 January 28, 2026, the Company issued a press release announcing that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson’s disease. The IND clearance allows Serina to proceed with regulatory and site-level activities to support initiation of a planned Phase 1b registrational clinical study evaluating SER-252 in patients with advanced Parkinson’s disease. A copy of the press release is filed as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

Item 9.01 - Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press Release, dated January 28, 2026, announcing FDA Clearance of IND Application for SER-252 for the Treatment of Advanced Parkinson’s disease
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: January 28, 2026			By:			/s/ Steve Ledger
						Chief Executive Officer

FAQ

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

Serina Therapeutics announced that the FDA has cleared its IND application for SER-252, an investigational therapy for advanced Parkinson’s disease. This clearance authorizes the company to begin regulatory and site-level work for a planned Phase 1b registrational clinical study.

What does FDA IND clearance mean for SER-252 and Serina Therapeutics?

FDA IND clearance means regulators have reviewed SER-252’s preclinical and proposed clinical data package and allowed human testing to proceed. For Serina Therapeutics, it enables a planned Phase 1b registrational study in advanced Parkinson’s disease, moving the program from preclinical work into clinical development.

What stage of clinical development is planned for SER-252 in Parkinson’s disease?

Serina Therapeutics plans a Phase 1b registrational clinical study of SER-252 in patients with advanced Parkinson’s disease. A registrational study is typically structured so that, if results are favorable, the data may support a future regulatory marketing application for approval.

Which condition is SER-252 intended to treat?

SER-252 is described as an investigational therapy for advanced Parkinson’s disease. The planned Phase 1b registrational clinical study will evaluate SER-252 in patients with advanced forms of this neurodegenerative disorder, aiming to generate safety and efficacy data in that population.

How does the IND clearance affect Serina Therapeutics’ clinical plans?

With the IND cleared, Serina Therapeutics can advance regulatory and site-level activities needed to start its Phase 1b registrational study of SER-252. These activities typically include site selection, ethics approvals, operational setup, and preparing to enroll patients with advanced Parkinson’s disease.

Where can investors find more details on the SER-252 announcement?

More details are provided in a press release dated January 28, 2026, which describes FDA clearance of the IND application for SER-252 in advanced Parkinson’s disease. That press release has been filed as Exhibit 99.1 and is incorporated by reference into the company’s disclosure.