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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): November 26, 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
1.01 | Entry
into a Material Definitive Agreement |
On
November 26, 2024, Serina Therapeutics, Inc., a Delaware corporation (the “Company”), entered into an agreement (the “Agreement”)
with Juvenescence Limited and JuvVentures (UK) Limited (including its successors and assigns, “Juvenescence”) pursuant to
which Juvenescence purchased shares of the Company’s common stock, $0.0001 par value (the “Common Stock”) and warrants
to purchase Common Stock for cash and the surrender by Juvenescence of certain previously issued warrants. The Agreement also provided
for certain amendments to that certain Letter Agreement, dated August 29, 2023, between the Company and Juvenescence (the “Letter
Agreement”), as described below.
Purchase
and Sale of Common Stock and Incentive Warrants
Pursuant
to the Agreement, Juvenescence agreed to purchase from the Company 1,000,000 shares of Common Stock at the purchase price of $10.00 per
share, for an aggregate amount of $10 million in two tranches as described below, along with warrants to purchase an additional 755,728
shares of Common Stock at an exercise price of $18.00 per share (the “Replacement Incentive Warrants”). The Replacement Incentive
Warrants expire on March 26, 2028, and have substantially the same terms and conditions as the surrendered Incentive Warrants (as defined
below).
The
closing on the first tranche of 500,000 shares of Common Stock for an aggregate of $5 million occurred on November 27, 2024. In connection
with the first tranche closing, Juvenescence pledged 122,136 shares of Common Stock to the Company as security for the closing of the
second tranche. If the second tranche closing does not occur on or before January 31, 2025, due to Juvenescence’s failure to comply
with the terms of the Agreement, then the pledged shares will be transferred to the Company.
Under
the Agreement, Juvenescence also agreed to purchase the second tranche of 500,000 shares of Common Stock and the corresponding Replacement
Incentive Warrants for a second aggregate payment of $5 million.
The
Agreement requires that the Company file a registration statement on or before April 2, 2025, to register Juvenescence’s resale
of the shares issued pursuant to the Agreement and upon the exercise of the Replacement Warrants.
Surrender
of Post-Merger Warrants
In
consideration for the Agreement, Juvenescence surrendered to the Company 755,728 warrants (the “Post-Merger Warrants”) issued
to Juvenescence pursuant to that certain warrant agreement, dated March 19, 2024, by and between the Company and Equiniti Trust Company,
LLC (the “Warrant Agreement”), including all underlying Incentive Warrants (as defined in the Warrant Agreement) issuable
upon exercise thereof. Upon surrender, the Company cancelled of the surrendered Post-Merger and Incentive Warrants.
Amendment
to Letter Agreement
The
stock purchases by Juvenescence under the Agreement are in lieu of future required exercises by Juvenescence of the Post-Merger Warrants
pursuant to the Letter Agreement, which would have resulted in similar proceeds to the Company but at later dates. Accordingly, the Letter
Agreement was amended to delete the requirements for Juvenescence to exercise the Post-Merger Warrants in Section 2 of the Letter Agreement.
Relationships
between the Company and Juvenescence
Juvenescence
is the largest holder of the Company’s Common Stock and, under the Letter Agreement, has appointed Greg Bailey and Richard Marshall
as its designees to the Company’s Board of Directors. Additional information about the relationships among the Company, Juvenescence,
and Messrs. Bailey and Marshall is described under note 4, Related Party Transactions, in the Notes to Condensed Consolidated
Interim Financial Statements in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, which description
is hereby incorporated by reference.
Because
of the relationships among the Company, Juvenescence, and Messrs. Bailey and Marshall, in considering the Agreement, the Company’s
Board of Directors established and delegated to a special committee comprised solely of independent and disinterested directors (the
“Special Committee”) the power and authority to evaluate, negotiate and approve, or decline to approve, the Agreement and
the related transactions. On November 26, 2024, the Special Committee approved the execution and delivery by the Company of the Agreement
and the related transactions, including for purposes of the Company’s Related Person Transaction Policy.
Item
3.02 | Unregistered
Sales of Equity Securities |
The
disclosures set forth in Item 1.01 above are incorporated by reference into this Item 3.02. The shares of Common Stock issued under the
Agreement were, and the shares of Common Stock issuable under the Agreement and upon exercise of the Replacement Incentive Warrants will
be, issued pursuant to the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended
(the “Securities Act”), and Rule 506(b) of Regulation D as promulgated by the SEC under the Securities Act.
On
December 2, 2024, the Company issued a press release, a copy of which is furnished as Exhibit 99.1 hereto and incorporated by reference
into this Item 8.01, announcing that the Company had entered into the Agreement.
Item
9.01 | Financial
Statements and Exhibits |
(d)
Exhibits
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 2, 2024 |
By: |
/s/
Steve Ledger |
|
|
Chief
Executive Officer |
Exhibit
99.1
Serina
Therapeutics Secures $10 Million Financing to Continue Advancing Lead IND Candidate
into
Phase 1 Clinical Trial in Advanced Parkinson’s Disease Patients
HUNTSVILLE,
December 2, 2024 (GLOBE NEWSWIRE) — Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage
biotechnology company, today announced a $10 million equity financing with strategic shareholder JuvVentures (UK) Limited. The transaction
provides Serina with funding to continue advancing SER-252 (POZ-apomorphine), enabled by its proprietary POZ Platform™ drug optimization
technology, into a Phase 1 clinical trial in advanced Parkinson’s disease patients in the second half of 2025.
Under
the terms of the funding agreement, Serina will issue one million shares of common stock at $10 per share, a 120% premium to the closing
price on November 26, 2024. The financing will be delivered in two tranches: the first $5.0 million tranche was received November 27,
2024, and the second $5.0 million tranche by January 31, 2025. Serina filed a Form 8-K with the SEC on December 2, 2024 that provides
additional information regarding this transaction.
About
SER-252 (POZ-apomorphine)
SER
252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic
stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) and enable greater
on time, with reduced off time, in advanced Parkinson’s patients. SER-252 leverages strategic partner Enable Injections’
enFuse™ wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer,
long-acting subcutaneous injection without skin reactions.
About
the POZ Platform™
Serina’s
proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ
technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered
via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs
that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes
that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the
blood.
Serina’s
POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional
applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license
agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.
About
Serina Therapeutics
Serina
is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases
and other indications. Serina’s POZ PlatformTM 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 the company’s Annual Report on Form 10-K for the year ended December 31, 2023, the company’s Current Report
on Form 8-K that was filed with the SEC on April 1, 2024, and the company’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
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