Form 8-K - Current report

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): July 29, 2024

Serina Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	1-38519	82-1436829
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	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 ☒

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. ☒

Item 7.01 Regulation FD Disclosure

On July 29, 2024, Serina Therapeutics, Inc. (the “Company”) issued a press release announcing that Randall Moreadith, M.D., Ph.D., the Company's Chief Development Officer, will participate in the 4^th Annual mRNA-Based Therapeutics Summit held between July 29 and July 31, 2024 (“Therapeutics Summit”) in Boston, Massachusetts and will be using the materials furnished as Exhibit 99.1 to this report (the “Presentation”) in connection with the Therapeutics Summit. The Presentation is incorporated into this Item 7.01 by reference. A copy of the press release is furnished as Exhibit 99.2 hereto and is incorporated into this Item 7.01 by reference.

The information in this Item 7.01 is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in Item 7.01 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company or any of its affiliates.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit Number		Exhibit Description
99.1		Presentation of Serina Therapeutics, Inc. to be used beginning July 29, 2024
99.2		Press Release, dated July 29, 2024, issued by Serina Therapeutics, Inc.
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: July 29, 2024	By:	/s/ Steven Ledger
		Interim Chief Executive Officer

Exhibit 99.1

Exhibit 99.2

Serina Therapeutics to Present Novel Data on POZ-Lipid Technology Potentially Enhancing Safety and Efficacy of mRNA LNP Formulations at the 4th mRNA-Based Therapeutics Summit

HUNTSVILLE, Jul. 29, 2024 (GLOBE NEWSWIRE) — Serina Therapeutics (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform^TM drug delivery technology, today announced that Randall Moreadith, MD, Ph.D., Chief Development Officer, will present at the 4th Annual mRNA-Based Therapeutics Summit. The conference will take place from July 29-31, 2024, in Boston, MA.

Dr. Moreadith’s presentation, titled “Overcoming Anti-PEG Antibody Responses to Increase Potency & Decrease Adverse Side Effects of mRNA-LNP Formulations”, is scheduled for 9:00 AM ET on Monday, July 29. In this talk, Dr. Moreadith will present novel data on Serina Therapeutics’ innovative POZ-lipid, a proprietary technology that aims to significantly advance the safety and efficacy of mRNA-LNP formulations. These data show that POZ-lipid does not induce an IgM or IgG antibody response, even with repeated dosing in in vivo models.

This finding is crucial because the PEG-lipids currently used in mRNA vaccines can elicit an anti-PEG antibody response. This response is associated with serious adverse events, including anaphylaxis, which can pose a life-threatening risk to patients. The presentation will provide insights into how Serina’s POZ-lipid technology can potentially mitigate these adverse effects, thereby enhancing the safety and efficacy profile of mRNA-LNP medicines.

Conference Details:

Event: 4th Annual mRNA-Based Therapeutics Summit “Turbocharging New Frontiers of mRNA Medicine to Patients Faster”

Date: July 29-31, 2024

Location: Boston, MA

Presentation Title: “Overcoming Anti-PEG Antibody Responses to Increase Potency & Decrease Adverse Side Effects of mRNA-LNP Formulations”

Presenter: Randall Moreadith, MD, PhD, Chief Development Officer, Serina Therapeutics, Inc.

Time: 9:00 AM ET, Monday, July 29

For more information about the conference and to view the agenda, please visit mRNA-Based Therapeutics Summit Agenda.

About Serina Therapeutics

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases, cancer, and other indications. Serina’s POZ Platform^TM provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.

For more information, please visit https://serinatherapeutics.com.

Cautionary Statement Regarding Forward-Looking Statement

This release contains forward-looking statements within the meaning of federal securities laws. 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. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, 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; 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 Serina’s Annual Report on Form 10-K for the year ended December 31, 2023, Serina’s Current Report on Form 8-K that was filed with the SEC on April 1, 2024, and Serina’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 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:

Investor.relations@serinatherapeutics.com
(256) 327-9630

Cover	Jul. 29, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 29, 2024
Entity File Number	1-38519
Entity Registrant Name	Serina Therapeutics, Inc.
Entity Central Index Key	0001708599
Entity Tax Identification Number	82-1436829
Entity Incorporation, State or Country Code	DE
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	SER
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	true