aibio60 Degrees outlines next steps after its babesiosis hospital study interim analysis
Tickers SXTP
At an October 6, 2026 webinar, the company said 30 patients were enrolled in its hospital study and that it plans to complete the current dataset and move to unblinding.
Key facts
- Company
- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP)
- News type
- Company Updates
- Primary source
- 60 Degrees Pharmaceuticals, Inc. 8-K (2026-10-06)
60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP) held a webinar on October 6, 2026 on tafenoquine for severe babesiosis. The investor presentation was furnished to the Securities and Exchange Commission as an exhibit to a Form 8-K filed the same day. The agenda covered the clinical context and current standard of care, published evidence for tafenoquine plus atovaquone, the hospital study's interim analysis and feedback from the data safety monitoring board (DSMB), next steps and the regulatory path, and near-term catalysts.
The hospital study
The deck describes a randomized, placebo-controlled study of tafenoquine plus standard of care against placebo plus standard of care in hospitalized babesiosis patients. It says 30 patients were enrolled as of October 1, 2026. The primary endpoint is time to sustained clinical resolution (TTSCR), and follow-up runs through early January 2027.
A slide on interim analysis scenarios lays out the outcomes that could follow the DSMB's recommendation. These include ending the study early if the endpoint is met, enrolling more subjects, or completing the study as originally planned. For the current data, the slide's stated next step is to complete the 30-patient dataset and move to unblinding, not to end the study early on a met endpoint. The deck discloses no interim efficacy result, p-value or conditional power for the trial, so what the DSMB saw is not public.
The deck also addresses enrolling the final three subjects. It says that waiting adds a full tick season, that enrolling those three would defer complete data output until fall 2027, and that the statistical benefit of three additional patients is limited.
The expanded access study
The deck says six patients are enrolled in the expanded access study for relapsing immunosuppressed patients. The first three were NAT-negative after therapy. Patients four and five were expected to complete follow-up in early November, and a sixth patient had just been enrolled. The study uses NAT to define parasite clearance.
The deck summarizes the Krause and colleagues case series in Clinical Infectious Diseases, published in 2024. It says four of five patients achieved definitive clearance with tafenoquine-containing regimens, that successful cases used other antimicrobials, including atovaquone-proguanil in three cases, and that tafenoquine alone failed to prevent relapse in one case. The dosing shown is a 600 mg loading dose followed by 200 or 300 mg weekly maintenance. That is a published series of five patients, and in one case tafenoquine alone failed to prevent relapse.
The deck also cites a SCID mouse model of B. microti. In that model, the combination of atovaquone and tafenoquine prevented detectable recrudescence through the end of follow-up, while neither drug alone achieved that result. The source cited is Vydyam and colleagues in the Journal of Infectious Diseases, 2024. Mouse results do not show that the combination works in people.
The product and the market
ARAKODA (tafenoquine) received US FDA approval in 2018 and became commercially available in 2019 for malaria prophylaxis in adults. The deck says eight studies involved more than 1,100 patients, that the 52-week adverse event rate was comparable to placebo, and that G6PD screening is required. It notes that ARAKODA is not approved for the treatment or prevention of babesiosis.
Its pipeline slide lists the ARAKODA regimen for human babesiosis as a program and says the company is preparing a dossier for an FDA meeting.
Financial position
The annual report filed March 30, 2026 reported revenue of $1.0 million for 2025 and $607,574 for 2024. The net loss was $7.4 million in 2025 and $7.9 million in 2024. The quarterly report filed August 14, 2026 gives cash and cash equivalents of $1.0 million at June 30, 2026. The deck's own risk language says there is substantial doubt about the company's ability to continue as a going concern, and cash from operations was negative $6.8 million in 2025.
What comes next
The deck dates unblinding of the hospital study to early January 2027, after follow-up runs through that period. Its program slides are labeled as planning for 2027, and ARAKODA is not approved for babesiosis, so FDA review of any babesiosis use has not started.