60 Degrees Pharma details babesiosis trial analysis

60 Degrees Pharmaceuticals outlined its statistical analysis plan for an interim look at its randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis.

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

60 Degrees Pharmaceuticals outlined its statistical analysis plan for an interim look at its randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis. An interim analysis is planned for the earlier of October 30, 2026 or after 24 of 33 planned patients have been randomized and followed for at least 50 days.

The plan uses conditional power analyses for time to sustained clinical resolution and time to molecular cure, with potential early reporting or sample size increase up to 66 patients. As of this notice, 23 patients had been enrolled. If results support an sNDA, the company aims to pursue a Commissioner’s National Priority Review Voucher before the end of the first quarter of 2028.

Insights

Company sets clear interim analysis and sNDA pathway for tafenoquine babesiosis trial.

60 Degrees Pharmaceuticals has defined a formal statistical analysis plan for its severe babesiosis tafenoquine study. The interim review will occur by October 30, 2026 or once 24 of 33 planned patients have sufficient follow-up, using conditional power to guide decisions.

The design allows early reporting if conditional power for time to sustained clinical resolution is high, or a sample size increase up to 66 patients if results are intermediate. A Data Safety Monitoring Board will review interim findings while sponsor and investigators remain blinded, which helps preserve trial integrity.

The company links positive interim or final outcomes to a potential supplementary New Drug Application and a Commissioner’s National Priority Review Voucher request before the end of Q1 2028. Actual outcomes and timing will depend on enrollment progression, interim statistics, and regulatory feedback described in future disclosures.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Initial planned enrollment: 33 patients Interim trigger date: October 30, 2026 Enrollment-based interim trigger: 24 patients +5 more

8 metrics

Initial planned enrollment 33 patients Planned patients in severe babesiosis tafenoquine trial

Interim trigger date October 30, 2026 Calendar-based trigger for interim analysis

Enrollment-based interim trigger 24 patients Randomized and followed at least 50 days to trigger interim

Maximum sample size 66 patients Sample size increase capped at 33 additional patients

Patients enrolled 23 patients Enrolled in the study as of the notice date

Early reporting significance level 0.02137 (one-sided) Log-rank test significance threshold for early reporting

High conditional power threshold 80% Conditional power level that can trigger early reporting test

Intermediate conditional power range 50%–80% Range that prompts sample size reassessment

Key Terms

statistical analysis plan, conditional power, time to sustained clinical resolution (TTSCR), time to molecular cure (TTMC), +3 more

7 terms

statistical analysis plan technical

"the Company prepared, and as of the date of this notice was preparing for submission to the U.S. Food and Drug Administration, a statistical analysis plan"

A statistical analysis plan is a detailed written blueprint that explains exactly how study data will be measured, compared and reported, including which outcomes will be examined, which calculations will be used, and how missing or messy data will be handled. For investors it matters because a clear, pre‑set plan reduces the risk of biased or surprising results—think of it as a recipe that ensures reported findings are reproducible and trustworthy for judging a drug or product’s prospects.

conditional power technical

"A conditional power (CP) analysis will be performed for time to sustained clinical resolution"

time to sustained clinical resolution (TTSCR) medical

"conditional power (CP) analysis will be performed for time to sustained clinical resolution (TTSCR)"

time to molecular cure (TTMC) medical

"conditional power (CP) analysis will be performed for time to sustained clinical resolution (TTSCR) and for time to molecular cure (TTMC)"

Data Safety Monitoring Board regulatory

"The results of the interim analysis will be presented to the DSMB for recommendation to the sponsor."

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

supplementary New Drug Application (sNDA) regulatory

"supports moving forward with a supplementary New Drug Application (sNDA) submission to the FDA"

A supplementary new drug application (sNDA) is a formal request to a drug regulator to approve a change to an already approved medicine, such as a new use, strength, formulation, or labeling. Think of it like asking for a permit to change a product so it can serve more customers or be used in a different way. Investors care because approved changes can expand sales, extend a drug’s commercial life, and alter revenue and risk profiles.

Commissioner’s National Priority Review Voucher regulatory

"The Company intends to submit an application for a Commissioner’s National Priority Review Voucher"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did 60 Degrees Pharmaceuticals (SXTP) disclose about its tafenoquine babesiosis trial?

60 Degrees Pharmaceuticals described a detailed statistical analysis plan for an interim review of its randomized, placebo-controlled tafenoquine trial in severe babesiosis, including timing, decision rules for early reporting or sample size increase, and links to potential sNDA and voucher applications.

When is the interim analysis planned for the SXTP tafenoquine severe babesiosis study?

The interim analysis will occur at the earlier of October 30, 2026 or after 24 of the 33 planned patients have been randomized and followed for at least 50 days, establishing a clear calendar and enrollment-based trigger for the interim review.

How many patients are planned and currently enrolled in SXTP’s babesiosis trial?

The trial plans to enroll 33 patients initially, with a potential increase to 66. As of the disclosure date, 23 patients had been enrolled, indicating the study is close to the 24-patient threshold that can also trigger the interim analysis after adequate follow-up.

What statistical criteria could lead to early reporting in the SXTP tafenoquine trial?

If conditional power for time to sustained clinical resolution is at least 80%, a log-rank test will be performed and a one-sided significance level of 0.02137 or less would result in early reporting of the study, subject to Data Safety Monitoring Board review.

Could 60 Degrees Pharmaceuticals seek a Priority Review Voucher for tafenoquine?

The company intends to apply for a Commissioner’s National Priority Review Voucher if interim and/or final trial results support pursuing a supplementary New Drug Application before the end of the first quarter of 2028, tying regulatory incentives to positive clinical outcomes.

How will decisions from the interim analysis be made in SXTP’s babesiosis trial?

Interim results will be presented to the Data Safety Monitoring Board, which will make recommendations to the sponsor. The sponsor and investigators will remain blinded and will not know the calculated conditional power for key endpoints if the study continues after review.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 07/09/2026 - 04:05 PM

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

Source: View Original Filing on SEC EDGAR

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60 Degrees Pharma details babesiosis trial analysis

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