60 degrees pharmaceuticals, Inc. Stock Price, News & Analysis

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW), a company focused on developing new medicines for infectious diseases, has regained compliance with Nasdaq's minimum bid price requirement. The company received written notice from Nasdaq on August 26, 2024, confirming its compliance with the Minimum Bid Price Requirement set forth in Nasdaq Listing Rule 5550(a)(2).

60P had been notified of non-compliance on February 27, 2024, as its common stock failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. To regain compliance, the company needed to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This was achieved between August 12, 2024, and August 23, 2024, with the company's closing price reaching $1.81 on August 23, 2024.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) reported Q2 2024 financial results, showing significant growth in net product revenues. Key highlights include:

- Net product revenues doubled year-over-year to $125,000
- Sequential quarter-over-quarter revenue growth of 18.3%
- Gross profit improved from ($124,000) loss to $35,000 gain
- ARAKODA® pharmacy deliveries increased by 288%
- Operating expenses rose to $4.22 million, impacted by a non-recurring R&D charge
- Net loss widened to $4.29 million or ($4.23) per share

The company also reported progress in its clinical trials, with the first patient enrolled in a tafenoquine study for Babesiosis at Tufts Medical Center. Additionally, the FDA granted Orphan Drug Designation for tafenoquine in acute babesiosis treatment.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has granted the University of Kentucky a right of reference to its NDA for ARAKODA® (tafenoquine), an FDA-approved anti-malarial. This allows the FDA to review ARAKODA's data when evaluating protocols for the university's upcoming Phase IIb study of SJ733, an oral ATP4 inhibitor of Plasmodium, combined with tafenoquine for vivax malaria treatment.

The study, funded by the Global Health Innovative Technology Fund, aims to evaluate the safety, tolerability, and pharmacokinetics of this single-dose combination. It potentially offers a significant advancement in malaria treatment, especially in areas with chloroquine-resistant P. vivax. 60 Degrees Pharma will supply tafenoquine and placebos for the trial.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has announced a 1:12 reverse stock split of its common stock, effective August 12, 2024. This move is primarily aimed at complying with Nasdaq's $1.00 minimum bid price requirement to maintain its listing. The stock will continue trading under the symbol 'SXTP' with a new CUSIP number 83006G203. The split will automatically convert 12 current shares into one new share, with proportional adjustments made to equity awards, warrants, and convertible notes. No fractional shares will be issued, and all fractions will be rounded up. The split won't alter the par value or authorized number of shares, and stockholders' percentage interests will remain unchanged.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has been awarded a contract with the U.S. Army Medical Materiel Development Activity to support commercial validation of new packaging for ARAKODA® (tafenoquine), its FDA-approved malaria prevention product. This follows the company's increase in ARAKODA's commercial batch size in Q1 2024, anticipating higher sales volume. Notably, Q1 2024 ARAKODA sales revenue surged 515% year-over-year to $105.7 thousand.

The company aims to ensure a sustainable supply of ARAKODA for civilian and military customers in the U.S. Additionally, 60 Degrees Pharmaceuticals is exploring ARAKODA's potential role in treating babesiosis, an emerging tick-borne disease that can be life-threatening in elderly and immunosuppressed patients.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has signed clinical trial agreements with Yale University, Rhode Island Hospital, and Tufts Medical Center for its Tafenoquine Babesiosis Study. This marks the world's first randomized, double-blind, placebo-controlled trial evaluating tafenoquine's efficacy and safety in treating relapsing babesiosis. The study aims to enroll 24-33 hospitalized patients, with interim results expected by September 2025.

Babesiosis, a tick-borne illness, is becoming increasingly prevalent in the Northeast U.S. Recent case studies suggest tafenoquine combined with standard treatment shows high cure rates in immunosuppressed patients with relapsing babesiosis. The total accessible market for ARAKODA® (tafenoquine) for babesiosis in the U.S. is estimated at 400,000 patients through December 2035.

60 Degrees Pharmaceuticals announced IRB approval for an open-label study of the ARAKODA® regimen of tafenoquine to treat persistent babesiosis in immunocompromised patients. The study aims to replicate the 80% cure rate observed in an earlier Yale School of Public Health case series. Tafenoquine, approved for malaria prophylaxis in the U.S., has not been proven effective for babesiosis treatment or prevention. The increasing incidence of babesiosis, a tick-borne illness, particularly affects the elderly and immunosuppressed. This clinical program is now enrolling at Tufts Medical Center.

60 Degrees Pharmaceuticals (SXTP) has enrolled the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine in treating human babesiosis. The randomized, double-blind, placebo-controlled study aims to enroll 24-33 participants to assess time to sustained clinical resolution and molecular cure using an FDA-approved nucleic acid test. Tafenoquine, already approved for malaria prophylaxis under the name ARAKODA, has been designated as an orphan drug by the FDA for this new indication. Babesiosis, a tick-borne disease, poses significant health risks, particularly for the elderly and immunosuppressed.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has received FDA orphan drug designation for its tafenoquine candidate, aimed at treating acute babesiosis. This designation offers benefits such as market exclusivity, tax credits, and exemption from certain FDA fees.

The company has partnered with Tufts Medical Center to conduct the first clinical trial evaluating tafenoquine's efficacy and safety in humans, starting June 13, 2024. The trial will involve at least 24 hospitalized patients and may expand to additional sites in the Northeast U.S.

Babesiosis, a disease transmitted by ticks, can be life-threatening, especially in elderly or immunosuppressed individuals. Up to 47,600 of the estimated 476,000 Lyme disease patients in the U.S. each year may be co-infected with Babesia.

CEO Geoff Dow emphasized the need for new therapeutic options, highlighting promising animal study results for tafenoquine.