FDA feedback supports Serina (NYSE: SER) SER-252 registrational plan

Rhea-AI Filing Summary

Serina Therapeutics reported that the U.S. Food and Drug Administration provided written feedback after a recent Type B meeting supporting advancement of its drug candidate SER-252 (POZ-apomorphine) into a registrational clinical study program for advanced Parkinson’s disease. The program is expected to proceed under the 505(b)(2) New Drug Application pathway, which allows reliance on certain existing data for approval. The company communicated this update through a press release that is attached as an exhibit to the report.

Positive

• FDA feedback supports registrational program for SER-252, marking a significant regulatory step toward a potential New Drug Application in advanced Parkinson’s disease under the 505(b)(2) pathway.

Negative

• None.

Insights

Biopharma regulatory analyst

FDA feedback supports moving SER-252 into registrational trials, a key regulatory milestone.

The company states that written feedback from a recent FDA Type B meeting supports advancing SER-252 (POZ-apomorphine) into a registrational clinical study program for advanced Parkinson’s disease. A registrational program is typically designed to support a future marketing application, so this feedback helps define a potential path toward approval.

The program is planned under the 505(b)(2) NDA pathway, which can allow use of existing data from other products alongside new studies. That structure may streamline development compared with a full 505(b)(1) route, though requirements still depend on FDA’s expectations and future study results.

The update is communicated via a press release furnished as an exhibit, indicating this is a regulatory interaction rather than an approval. Future outcomes will depend on the design, execution, and results of the planned registrational studies and any subsequent FDA review.

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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): August 25, 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 August 25, 2025, the Company issued a press release announcing that following a recent Type B meeting with the FDA, the Agency’s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinsons’s under the 505(b)(2) NDA pathway. A copy of the press release is furnished 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 announcing the FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway
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: August 25, 2025			By:			/s/ Steve Ledger
						Chief Executive Officer

FAQ

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

The company reported that after a recent Type B meeting, the FDA’s written feedback supports advancing SER-252 (POZ-apomorphine) into a registrational clinical study program for advanced Parkinson’s disease under the 505(b)(2) NDA pathway.

What is SER-252 in Serina Therapeutics' pipeline?

SER-252 is described as POZ-apomorphine, a drug candidate being advanced for advanced Parkinson’s disease. FDA feedback now supports moving it into a registrational clinical study program.

Did the FDA approve SER-252 in this Serina Therapeutics (SER) update?

No. The company states that FDA written feedback after a Type B meeting supports advancing SER-252 into a registrational clinical study program under the 505(b)(2) pathway. This is not described as an approval, but as support for trial design and development path.

What is the significance of the 505(b)(2) NDA pathway for Serina Therapeutics?

The filing notes that SER-252 is being advanced under the 505(b)(2) NDA pathway, which allows a drug sponsor to rely in part on existing data from prior studies or approved products alongside its own data, potentially shaping the development and approval strategy for advanced Parkinson’s disease.

How did Serina Therapeutics disclose the FDA feedback on SER-252?

Serina Therapeutics furnished a press release as Exhibit 99.1, describing that FDA’s written feedback supports the registrational trial design for SER-252 in advanced Parkinson’s disease under the 505(b)(2) NDA pathway, and incorporated that press release by reference.

Does this Serina Therapeutics 8-K include financial statements or major transactions?

The report is filed under Item 8.01 Other Items and focuses on FDA feedback regarding SER-252 and the planned registrational clinical program. It does not describe major transactions or earnings data in the provided content.