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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): June 3, 2026
60
DEGREES PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-41719 |
|
45-2406880 |
(State
or other jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification Number) |
1025
Connecticut Avenue NW Suite 1000,
Washington,
D.C. |
|
20036 |
| (Address
of registrant’s principal executive office) |
|
(Zip
code) |
(202) 327-5422
(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 (see General Instruction A.2. below):
| ☐ |
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, par value $0.0001 per share |
|
SXTP |
|
The Nasdaq Stock
Market LLC |
| Warrants,
each warrant to purchase one share of Common Stock |
|
SXTPW |
|
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
8.01 Other Events
The
Company intends to submit an application for a Commissioner’s National Priority Review Voucher if the outcome of any interim and/or
final analysis of the Company’s randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis
supports moving forward with a New Drug Application submission to the U.S. Food and Drug Administration (“FDA”) before the
end of the first quarter of 2028. The Company is providing this disclosure to inform investors regarding its current development and
regulatory plans. The Company’s expectations regarding the trial, any future NDA submission, and any potential voucher application
are forward-looking statements and are subject to risks and uncertainties, including the outcome of clinical development, interactions
with regulatory authorities, and other factors that could cause actual results to differ materially from those anticipated.
Cautionary
Statement Regarding Forward-Looking Statements
This
Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Such statements involve risks and uncertainties that could cause the Company’s actual results and financial position
to differ materially. These risks and uncertainties include uncertainties associated with market conditions and other risks described
under the heading “Risk Factors” in the Company’s SEC Filings on Form 10-K and Form 10-Q. The Company assumes no responsibility
to update or revise any forward-looking statements to reflect events, trends or circumstances after the date hereof.
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.
| |
60
DEGREES PHARMACEUTICALS, INC. |
| |
|
| Date:
June 3, 2026 |
By: |
/s/
Geoffrey Dow |
| |
Name: |
Geoffrey
Dow |
| |
Title: |
Chief
Executive Officer and President |
