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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):
July 10, 2025
Klotho Neurosciences, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-41340 |
|
86-2727441 |
| (Commission File Number) |
|
(IRS Employer
Identification No.) |
13576 Walnut Street, Suite A
Omaha, NE 68144
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code (833) 931-6330
(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(s) |
|
Name of Each Exchange on Which Registered |
| Common Stock |
|
KLTO |
|
The Nasdaq
Stock Market LLC |
| Warrants |
|
KLTOW |
|
The Nasdaq Stock Market LLC |
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 10, 2025, Klotho
Neuroscience, Inc. (the “Company”) issued a press release regarding the U.S. Food and Drug Administration (the “FDA”) granting Orphan Drug Designation
for the Company’s KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis also know as “ALS” or “Lou Gehrig’s
Disease.” A copy of the press release is attached hereto as Exhibit 99.1.
The information contained in this Item 7.01 and
Exhibit 99.1, attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended and shall not be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the
Securities Exchange Act of 1934, as amended or the Securities Act of 1933, as amended whether made before or after the date hereof and
irrespective of any general incorporation language in any filings.
This Form 8-K contains forward-looking statements.
These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These
forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,”
“estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,”
“should,” “will,” “would,” “will be,” “will continue,” “will likely result,”
and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include
descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements
about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many
factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s
inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections
and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors
and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange
Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained
in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided
herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except
as required under applicable law.
Item
9.01 Financial Statements and Exhibits.
| Exhibits |
|
Description |
| 99.1 |
|
Press Release |
| 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.
| Dated: July 10, 2025 |
KLOTHO NEUROSCIENCES, INC. |
| |
|
|
| |
By: |
/s/ Joseph Sinkule |
| |
Name: |
Joseph Sinkule |
| |
Title: |
Chief Executive Officer |
2
