60 Degrees Pharmaceuticals, Inc. (SXTP) reported results for the first five patients to complete tafenoquine-containing combination treatment in its expanded access study of relapsing babesiosis in immunosuppressed patients. All five reported being much or very much improved and had negative conventional PCR results during treatment or follow-up. Four of five (80%) had nonreactive post-treatment blood-donor NAT results; the fifth had a reactive NAT despite a negative follow-up conventional PCR. NAT samples were collected 66–120 days after treatment.
Two additional patients remain on treatment, bringing enrollment to seven; the study remains open pending potential FDA discussions. The company expects to unblind its separate randomized, placebo-controlled hospitalized-patient study in January 2027 and then intends to request a pre-sNDA meeting. It plans to pursue accelerated approval if its efficacy dossier is based primarily on data from immunosuppressed patients with relapsing babesiosis. Tafenoquine is not FDA-approved to treat or prevent babesiosis, and the company cautioned that the small uncontrolled study and historical case comparisons may not predict outcomes in larger studies.
60 Degrees Pharmaceuticals, Inc. updated its investor presentation on tafenoquine development for babesiosis, covering chronic, relapsing and severe acute programs. Tafenoquine is not approved by FDA or EMA for babesiosis; the presentation lists approved uses for malaria prevention and single-dose radical cure of P. vivax malaria with chloroquine.
The randomized hospital study enrolled 30 subjects, remains blinded, and has follow-up completion and unblinding planned for January 2027. Three expanded-access patients had post-treatment NAT-negative results; outcomes for two others were pending. In the chronic B-FREE screening, 2 of 9 patients were positive on genus-level dPCR; 0 of 9 were positive on B. microti NAT and 0 of 9 on Mayo species-specific PCR, and no enrolled patient had yet qualified for the primary per-protocol analysis. A pre-sNDA meeting was planned for late January 2027. The presentation describes a potential sNDA in 2027, with the lead regulatory path depending on the hospital-study result, and a September 2026 request for national-priority review.
The presentation identifies substantial doubt about the company's ability to continue as a going concern as a risk.
60 Degrees Pharmaceuticals (SXTP) has suspended further enrollment in its randomized severe-babesiosis study and intends to finalize the analysis with the 30 subjects enrolled as of October 1, 2026. It plans to unblind the study and report primary and secondary endpoint results in January 2027. The DSMB recommended completing the originally planned enrollment of 33 patients; the company cites marginal impact from three additional patients and seasonal enrollment that could delay unblinding by a year.
The DSMB analysis identified no safety issues, but did not establish whether the study met its endpoints. The company plans to request a pre-sNDA meeting with FDA in January 2027. It also reported molecular cure, using a sensitive NAT, in the first three patients in its expanded-access study; screening data for two additional patients are expected in early November 2026. Any accelerated-approval pathway is subject to FDA review. The company states substantial doubt about its ability to continue as a going concern.
60 DEGREES PHARMACEUTICALS, INC. (SXTP) reports that on September 12, 2026 it submitted a Statement of Interest to the FDA requesting a Commissioner’s National Priority Voucher for an efficacy supplement to NDA 210607 for ARAKODA (tafenoquine) to treat babesiosis, a tick-borne parasitic disease with no FDA-approved therapy. The company highlights published case reports in treatment‑refractory babesiosis showing cure rates of about 83% when tafenoquine is added to atovaquone-based therapy, and confirms that all three currently evaluable patients in its FDA‑authorized expanded access study have been cured.
The company is conducting a randomized, double‑blind, placebo‑controlled trial (NCT06207370), with enrollment for a prespecified interim analysis complete and a DSMB review scheduled for October 1, 2026. Depending on that outcome, it plans either regular approval based on the trial or accelerated approval supported by expanded‑access and published data, targeting an sNDA submission in March–April 2027. The company states that CNPV review could allow tafenoquine to become the first FDA‑approved babesiosis treatment by or before the 2027 tick season, and it commits to manufacture more than 50% of the value of any CNPV‑supported products in the U.S. and to provide volume‑based discounts to federal programs.
60 Degrees Pharmaceuticals, Inc. (SXTP) furnished an updated investor presentation outlining its strategy to expand the label of its marketed antimalarial ARAKODA® (tafenoquine) from malaria prophylaxis into babesiosis and other tick-borne diseases. The presentation highlights non-clinical data, human case-series signals, and a planned staged regulatory path toward a potential sNDA in babesiosis, including an interim analysis on October 6, 2026 and subsequent FDA interactions.
The company reports Q2 2026 net product revenue of $208k, up 106% year over year, with gross profit of $57k and about 27% gross margin. A July 31, 2026 private placement raised approximately $1 in gross proceeds at $1.74 per share or pre-funded warrant, contributing to liquidity of about $1 cash and equivalents as of June 30, 2026 and operating cash use of about $5 over the prior six months, supporting runway into early October 2026. The company also discloses that there is substantial doubt about its ability to continue as a going concern and positions babesiosis as a potentially larger value driver, with an estimated $180M opportunity that could help triple the ARAKODA® asset value if successfully developed and approved.
60 Degrees Pharmaceuticals, Inc. is registering up to 1,769,593 shares of common stock for resale by existing selling stockholders. These include outstanding shares and shares issuable from pre-funded warrants, Series A and B common warrants, and placement agent warrants issued in a July 30, 2026 private placement. The company is not selling any shares and will receive no proceeds from stockholder resales, only any cash paid upon warrant exercise.
The company is a specialty pharmaceutical business focused on infectious diseases, led by its FDA-approved malaria prophylaxis Arakoda (tafenoquine). It is pursuing additional indications such as babesiosis, chronic babesiosis, and veterinary babesiosis through multiple clinical trials, while also advancing early programs in viral diseases via Celgosivir and Australian Chestnut Extract. Prior financing has included at-the-market offerings and a 1:4 reverse stock split that restored compliance with Nasdaq listing rules.
60 Degrees Pharmaceuticals, Inc. reported that for the six months ended June 30, 2026, net revenue was $133,175, down from $440,831 a year earlier as prior-period research revenue did not recur, while net product revenue increased. Operating expenses rose to $4,499,238, leading to a net loss attributable to the company of $4,353,740 and a net loss attributable to common stockholders of $4,604,865. Net cash used in operating activities was $4,973,280.
Cash and cash equivalents were $1,022,606 and total assets $4,282,694 at June 30, 2026. Management states there is substantial doubt about the company’s ability to continue as a going concern for one year from issuance, even after raising approximately $3.37 million through at-the-market offerings in early 2026 and disclosing an additional ~$0.7 million in net proceeds from a July 2026 PIPE offering. The company also carries a Level 3 derivative liability of $384,973 tied to a potential $10 million milestone payment to Knight Therapeutics and has significant customer concentration, with a small number of distributors accounting for most receivables and product revenues.
60 Degrees Pharmaceuticals, Inc. held its virtual 2026 annual stockholders meeting on August 5, 2026. As of the July 2, 2026 record date, 2,659,288 shares of common stock were outstanding. Holders of 1,107,592 shares, about 41.6% of the voting shares, were represented in person or by proxy, establishing a quorum pursuant to the Delaware General Corporation Law and the company’s amended and restated bylaws.
Stockholders cast more votes “for” than “withheld” for each of the five director nominees, including Geoffrey Dow (147,223 for; 25,031 withheld) and Eric Francois (141,202 for; 31,052 withheld), with 935,338 broker non-votes on each election. For each additional proposal on the agenda, the required affirmative vote of a majority of shares represented at the meeting was achieved, and each proposal was approved, with reported “for” votes ranging from 92,303 to 997,089.
60 Degrees Pharmaceuticals, Inc. received a Schedule 13G from Lind Global Fund III LP, Lind Global Partners III LLC, and Jeff Easton reporting a beneficial ownership position in its common stock.
Each reporting person has sole voting and dispositive power over 191,571 shares, representing 5.45% of the common stock. Their holdings consist of 191,571 shares of common stock and 191,571 Series A Warrants plus 191,571 Series B Warrants. Due to conversion limitations in the warrants, their beneficial ownership is limited to an aggregate of 191,571 shares. The warrants include a provision that restricts conversion if it would cause the holder to beneficially own more than 4.99% of the company.
60 Degrees Pharmaceuticals entered into securities purchase agreements with institutional investors on July 30, 2026 for a private placement priced at-the-market under Nasdaq rules. The company is issuing 191,571 shares of common stock at $1.74 per share and pre-funded warrants for 383,142 shares at $1.739, together with Series A and Series B common stock warrants.
The transaction covers a total of 574,713 common shares (or pre-funded warrants) plus Series A and short-term Series B warrants to purchase up to 574,713 shares each, all with an exercise price of $1.49 per share. Gross proceeds are approximately $1.0 million, before fees and expenses, with intended use for working capital, general operations and the company’s research and development program.
Pre-funded warrants are exercisable immediately at $0.001 per share and remain outstanding until fully exercised. The Series A warrants expire five years after the effective date of a resale registration statement and the Series B warrants after 24 months, and both are subject to a Beneficial Ownership Limitation generally capping holders at 4.99% or, at their election, 9.99% of outstanding common stock. H.C. Wainwright & Co. receives a 7.5% cash fee, a 1.0% management fee, expense reimbursements and warrants to purchase 43,103 shares at $2.175 per share. The unregistered securities rely on Section 4(a)(2) and Rule 506 of Regulation D, and the company has agreed to file resale registration statements using best efforts within 45 days of July 30, 2026, or 75 days if subject to full SEC review.