Serina Therapeutics (SER): FDA clinical hold on SER-252 IND

Serina Therapeutics (SER) reported that the U.S. Food and Drug Administration has placed a clinical hold on the company’s IND application for SER-252, its lead development program for advanced Parkinson’s disease.

Rhea-AI Filing Summary

Serina Therapeutics (SER) reported that the U.S. Food and Drug Administration has placed a clinical hold on the company’s IND application for SER-252, its lead development program for advanced Parkinson’s disease. The update was announced on November 3, 2025.

The company furnished a press release as Exhibit 99.1 providing the regulatory update on the SER-252 program.

Positive

• None.

Negative

• FDA clinical hold on the IND for SER-252, the company’s lead program for advanced Parkinson’s disease

Insights

Biotech regulatory analyst

FDA clinical hold on lead Parkinson’s IND is a material setback.

The FDA placed a clinical hold on SER-252, Serina Therapeutics’ lead program for advanced Parkinson’s disease. A clinical hold is an FDA order that prevents initiation or continuation of a clinical study until issues are resolved.

Because SER-252 is the lead program, the hold directly affects the near-term clinical path. The company issued a press release on November 3, 2025 as Exhibit 99.1 with the update. Subsequent filings may provide the FDA’s requested actions or timeline to address the hold.

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.

FAQ

What did Serina Therapeutics (SER) announce in this 8-K?

The company announced that the FDA placed a clinical hold on its SER-252 IND.

Which Serina Therapeutics program is affected by the FDA action?

SER-252, the company’s lead development program for advanced Parkinson’s disease.

When was the regulatory update on SER-252 announced?

On November 3, 2025.

Where can investors read more details about the update?

In the company’s press release filed as Exhibit 99.1.

Does this filing include financial results or guidance?

No. It provides a regulatory update and lists Exhibit 99.1.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 11/03/2025 - 06:03 AM Learn about SEC filing dates

0001708599false00017085992025-08-252025-08-25

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): November 3, 2025

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 November 3, 2025, Serina Therapeutics, Inc. (the "Company") issued a press release providing a regulatory update on the Company's SER-252 Program, announcing that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Investigational New Drug (IND) application for SER-252, Serina’s lead development program for 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 November 3, 2025, on Regulatory Update on SER-252 Program
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: November 3, 2025			By:			/s/ Steve Ledger
						Chief Executive Officer