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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 7, 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
On July 7, 2026, the Company prepared, and
as of the date of this notice was preparing for submission to the U.S. Food and Drug Administration (“FDA”), a statistical
analysis plan (the “SAP”) for the planned interim analysis of its randomized, placebo-controlled trial of tafenoquine in patients
hospitalized with severe babesiosis (NCT0627370). The SAP states the following:
“An interim analysis will be performed
at the earlier of (i) 10/30/26 or (ii) after 24 of the 33 planned patients have been randomized and followed for at least 50 days. A conditional
power (CP) analysis will be performed for time to sustained clinical resolution (TTSCR) and for time to molecular cure (TTMC), each independently.
If the CP is at least 80% then a log-rank test will be performed and a one-sided statistical significance of 0.02137 or less for time
to TTSCR will result in early reporting of the study. If the conditional power is between 50% and 80% for either TTSCR or TTMC then a
sample size reassessment will be performed. Sample size increase is capped at 33 additional patients (66 total). The results of the interim
analysis will be presented to the DSMB for recommendation to the sponsor. The Sponsor and investigators will be blind to the analysis
and will not know the calculated clinical power of either endpoint if the study is continued.”
As of the date of this Current Report, the
Company had enrolled 23 patients in this study. 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 supplementary New Drug Application (sNDA) submission to
the 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 sNDA 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: July 9, 2026 |
By: |
/s/ Geoffrey Dow |
| |
Name: |
Geoffrey Dow |
| |
Title: |
Chief Executive Officer and President |
