On Thursday, H.C. Wainwright maintained its Neutral stance on 60 Degrees Pharmaceuticals Inc (NASDAQ: SXTP), following the company's announcement on December 11 that it is expanding its clinical trial for Arakoda (tafenoquine) to include Brigham and Women's Hospital.
According to InvestingPro data, the stock has shown significant momentum recently, with strong returns over the past month despite trading below its Fair Value. Arakoda, an anti-malaria medication currently marketed in the U.S. and as Kodatef in Australia for patients 18 years and older, is undergoing a Phase 2/3 trial for the treatment of babesiosis, a rare disease transmitted by ticks.
The company-sponsored trial is a randomized, double-blind, multisite, and placebo-controlled study aimed at assessing the efficacy and safety of Arakoda in combination with standard of care medications for hospitalized patients with babesiosis.
The trial, which also includes Yale University, Rhode Island Hospital, and Tufts Medical (TASE:PMCN) Center as study sites, is set to enroll a minimum of 24 patients and up to 33 patients. InvestingPro analysis reveals that while the company holds more cash than debt on its balance sheet, it's currently experiencing rapid cash burn - a critical factor for investors monitoring clinical trial progress.
The endpoints of the trial focus on the time to sustained clinical resolution of symptoms and the time to molecular cure, as determined by an FDA-approved nucleic acid test. The study's design allows for a robust evaluation of Arakoda's potential benefits in a patient population in need of effective treatment options.
60 Degrees Pharmaceuticals anticipates that the trial will complete enrollment by September 30, 2025, with an interim analysis potentially occurring in early 2026. This timeline provides a framework for when further data on the efficacy of Arakoda in treating babesiosis can be expected.
With a current ratio of 5.26 and analysts anticipating sales growth, the company appears positioned to maintain operations through this development period. Subscribers to InvestingPro can access 12 additional key insights about SXTP's financial health and growth prospects.
Arakoda has already been granted FDA Orphan Drug Designation for the treatment of babesiosis, highlighting the medication's potential in addressing this rare condition. The expansion of the clinical trial to Brigham and Women's Hospital marks a significant step in the company's efforts to repurpose its anti-malaria drug for a new therapeutic use.
In other recent news, 60 Degrees Pharmaceuticals has launched a clinical trial for a babesiosis treatment, initiated a pilot program to promote its antimalarial medication, ARAKODA, and secured shareholder approval for several key proposals. The clinical trial, in collaboration with Brigham and Women’s Hospital, aims to evaluate the safety and efficacy of tafenoquine, a drug currently approved for malaria prophylaxis, combined with standard treatments for babesiosis.
The company's Q2 revenue doubled, largely due to a 288% increase in pharmacy deliveries of ARAKODA, despite a net loss due to increased operating expenses.
The company also disclosed a private placement sale of shares and warrants, with H.C. Wainwright & Co. as the exclusive placement agent. Ascendiant Capital maintains its Buy rating on 60 Degrees Pharmaceuticals. The company received approval from its shareholders for several critical proposals during its Special Stockholders Meeting, including the exercise of warrants, an amendment to its equity incentive plan, and a reverse stock split.
Despite these advancements, InvestingPro's analysis indicates a rapid cash burn rate that investors should monitor. Furthermore, the company's financial metrics show significant challenges, including negative gross profit margins and projected earnings decline for the current year.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.