Serina Therapeutics (NYSE: SER) files complete FDA hold response for SER-252 Parkinson's program

Rhea-AI Filing Summary

Serina Therapeutics, Inc. reported that it has submitted a complete response to the U.S. Food and Drug Administration’s clinical hold letter for SER-252, its lead program for advanced Parkinson's disease. The company disclosed that the FDA’s clinical hold letter for SER-252 was dated November 25, 2025, and that its response was submitted on December 10, 2025. Serina also issued a press release on this regulatory update, which is included as an exhibit to the report and incorporated by reference.

Insights

Biotech regulatory analyst

Serina has replied to the FDA’s clinical hold on SER-252, but outcomes are not yet disclosed.

Serina Therapeutics states that on December 10, 2025, it submitted a complete response to the FDA’s clinical hold letter for SER-252, its lead program for advanced Parkinson's disease. The clinical hold letter is dated November 25, 2025, indicating the regulatory questions or issues were raised recently.

This step is part of the standard FDA process when a clinical hold is imposed, and the submission is meant to address the agency’s concerns. The information provided does not describe the FDA’s specific issues or any change in status for SER-252, so the regulatory outcome remains unknown based on this report alone.

The company also issued a press release, filed as Exhibit 99.1, to provide more detail on the regulatory update. Future public communications and filings will be needed to see how the FDA responds to this complete submission for SER-252.

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): December 10, 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 December 10, 2025, Serina Therapeutics, Inc. (the “Company”) issued a press release providing a regulatory update on the Company's lead SER-252 program for advanced Parkinson's disease, announcing the submission of the Company’s complete response to the FDA’s clinical hold letter for SER-252, dated November 25, 2025. 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 December 10, 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: December 10, 2025			By:			/s/ Steve Ledger
						Chief Executive Officer

FAQ

What did Serina Therapeutics (SER) announce regarding its SER-252 program?

Serina Therapeutics announced that it submitted a complete response to the U.S. Food and Drug Administration’s clinical hold letter for SER-252, its lead program for advanced Parkinson's disease.

When did Serina Therapeutics submit its response to the FDA clinical hold on SER-252?

The company submitted its complete response to the FDA’s clinical hold letter for SER-252 on December 10, 2025.

What is the date of the FDA clinical hold letter for SER-252 mentioned by Serina Therapeutics?

The FDA’s clinical hold letter for SER-252 is dated November 25, 2025, according to Serina Therapeutics.

How did Serina Therapeutics communicate the SER-252 regulatory update to investors?

Serina Therapeutics issued a press release providing a regulatory update on SER-252, and this press release is filed as Exhibit 99.1 and incorporated by reference.

Does this Serina Therapeutics 8-K report confirm that the FDA lifted the clinical hold on SER-252?

No. The report states that Serina submitted a complete response to the FDA’s clinical hold letter for SER-252 but does not describe any FDA decision or change in the hold status.

What SEC form did Serina Therapeutics use to disclose the SER-252 regulatory update?

Serina Therapeutics used a Form 8-K current report under Item 8.01 (Other Events) to disclose the regulatory update on SER-252.