New 8-count bottles now available through major retail pharmaciesARAKODA® is the only weekly prophylactic therapy to provide protection against the blood and liver stages of malaria WASHINGTON, June 04, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the introduction of a new 8-count bottle format for ARAKODA® (tafenoquine). The 8-count bottle ...

Core Insights - 60 Degrees Pharmaceuticals, Inc. announced results from an insurance claims analysis indicating a significant discrepancy between the number of Americans seeking reimbursement for babesiosis-related medical costs and CDC estimates of actual cases [1][2][10] - The company is investigating the true burden of babesiosis, particularly its association with chronic fatigue, through ongoing clinical trials and studies [6][8][10] Claims Analysis - Approximately 25,000 Americans seek reimbursement for babesiosis-related medical costs annually, while CDC estimates only 2,000 cases in 2020 [2][10] - Claims data revealed that about 31% of babesiosis cases persist longer than 30 days, with nearly half of these cases associated with chronic fatigue lasting over six months [4][10] Chronic Fatigue Insights - Babesia infections can last at least 12 months in 14% of patients, with potential relapses occurring up to 27 months later [3] - Over three years, more than 12 million U.S. adults experienced chronic fatigue lasting more than six months, yet current guidelines do not mandate babesiosis as a differential diagnosis for such fatigue [5][10] Clinical Development - The company is conducting clinical trials to evaluate the safety and efficacy of tafenoquine in treating babesiosis, with data expected in the first half of 2026 [8][10] - A new drug application (NDA) for babesiosis is anticipated to be submitted to the FDA in 2026 [8][10] Product Information - Tafenoquine, marketed as ARAKODA, was approved for malaria prophylaxis in 2018 and is available as a prescription-only medication [9][10] - The drug has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [9]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenues and gross profit for Q1 2025, driven primarily by domestic sales of its lead product ARAKODA® [5][6]. Financial Highlights - Net product revenues for Q1 2025 increased by approximately 55% year-over-year, reaching about $163.6 thousand, up from $105.7 thousand in Q1 2024 [6]. - Gross profit for Q1 2025 was approximately $90.3 thousand, representing a 124% increase from approximately $40.2 thousand in Q1 2024 [5][6]. - Operating expenses rose to approximately $2.09 million in Q1 2025, compared to approximately $1.41 million in Q1 2024, with increased expenditures in sales and investor-related services contributing to this rise [6]. - The net loss attributable to common shareholders for Q1 2025 was approximately $2.01 million, or ($1.56) per share, contrasting with a net income of approximately $308.7 thousand, or $1.83 per share in Q1 2024 [6].

Financial Performance - Product revenues for the three months ended March 31, 2025, were $163,552, a 54.77% increase from $105,674 in the same period of 2024[181]. - Gross profit for the three months ended March 31, 2025, was $90,280, representing a 124.37% increase from $40,237 in the same period of 2024[180]. - Research revenues increased to $92,731 for the three months ended March 31, 2025, up 212.95% from $29,631 in the same period of 2024, driven by a new contract with USAMMDA[187]. - The gross margin percentage improved to 55.20% for the three months ended March 31, 2025, up from 38.08% in the same period of 2024[186]. - The company reported a net loss of $1,876,549 for the three months ended March 31, 2025, compared to a net income of $430,470 in the same period of 2024[179]. Cash Flow and Liquidity - The company had cash and cash equivalents of $3,451,500 as of March 31, 2025, compared to $1,659,353 as of December 31, 2024, indicating a significant increase in liquidity[163]. - Net cash used in operating activities for the three months ended March 31, 2025, was $1,597,366, up from $1,140,438 in the same period of 2024, reflecting increased operational costs[163]. - The net increase in cash and cash equivalents was $1,792,147 for the three months ended March 31, 2025, representing an increase of $1,039,932, or 138.25%, from $752,215 in 2024[195]. - Net cash provided by investing activities was $1,702,518 for the three months ended March 31, 2025, compared to a net cash used of $9,814 in the same period in 2024, marking a significant change of 17,447.85%[197]. - Net cash provided by financing activities decreased by $206,392, or 10.84%, to $1,696,899 for the three months ended March 31, 2025, compared to $1,903,291 in 2024[198]. Operational Highlights - The company suspended a Phase IIB study for the Arakoda regimen of Tafenoquine due to FDA guidance, pivoting back to focus on the commercialization of Arakoda for malaria[145]. - The company plans to increase sales of Arakoda, conduct clinical trials for new indications of Tafenoquine, and reposition small molecule therapeutics for new uses as part of its strategy for profitability[146]. - The FDA authorized the importation of Kodatef from Australia to mitigate potential shortages of Arakoda in the U.S. market due to high demand[155]. - The company enrolled the first patient in a clinical study for tafenoquine in treating persistent babesiosis, with patient enrollment expected to begin in Q3 2025[149]. - Arakoda sales volume increased by 55% to 1,579 boxes sold for the three months ended March 31, 2025, compared to 1,022 boxes in the same period of 2024[183]. - Kodatef sales to the Australian distributor were $12,066 for the three months ended March 31, 2025, compared to $1,004 in the same period of 2024, indicating a significant increase[184]. Expenses and Costs - Total operating expenses for the three months ended March 31, 2025, were $2,093,886, compared to $1,412,316 for the same period in 2024, reflecting increased R&D and administrative costs[179]. - Research and development costs increased by $70,440, or 20.89%, to $407,622 for the three months ended March 31, 2025, compared to $337,182 for the same period in 2024[188]. - General and administrative expenses rose by $611,130, or 56.84%, to $1,686,264 for the three months ended March 31, 2025, driven by higher sales, advertising, and promotion expenses[190]. - Total operating expenses increased by $681,570, or 48.26%, to $2,093,886 for the three months ended March 31, 2025, compared to $1,412,316 for the same period in 2024[188]. - Interest expense for the three months ended March 31, 2025, was $1,790, up from $1,402 in the same period in 2024, reflecting a 27.67% increase[191]. Auditor Concerns - The auditors expressed substantial doubt about the company's ability to continue as a going concern due to recurring operating losses and the need for additional capital[165]. - The company’s contractual obligations as of March 31, 2025, totaled $1,410,583, with $1,166,751 due within one year[171]. Accounting Standards and Regulations - The company has elected to take advantage of the JOBS Act exemption, delaying the adoption of certain accounting standards until they apply to private companies[213]. - The FASB issued ASU 2023-07, which expands disclosure requirements for reportable segments, effective for the 2024 annual period and interim periods beginning in 2025[215]. - ASU 2023-09 requires disaggregated information about effective tax rate reconciliation and income taxes paid, effective for annual periods beginning after December 15, 2024[216]. - ASU 2024-03 mandates public business entities to disclose disaggregated information about certain income statement expenses, effective for fiscal years beginning after December 15, 2026[217]. - The company is classified as a smaller reporting company and is electing scaled disclosure reporting obligations, thus not required to provide certain market risk information[218].

Core Insights - 60 Degrees Pharmaceuticals, Inc. has revealed that the actual burden of babesiosis in the U.S. may be significantly higher than CDC statistics indicate, with nearly 3 million Americans potentially diagnosed with the disease [1][2][9] - The survey conducted by the company suggests that babesiosis is underdiagnosed or underreported, indicating a greater demand for effective treatment than current CDC statistics suggest [2][5] - The company is developing treatment candidates for babesiosis and aims to define the commercial market size for these treatments [5][12] Survey Findings - The survey included 6,000 participants and found that 1.26% of respondents reported a diagnosis of babesiosis, equating to approximately 3 million Americans [6][9] - About 17% of those diagnosed with babesiosis reported experiencing illness for six months or more, suggesting at least 570,000 adults may have chronic disease [6][9] - Approximately 3.7% of respondents reported experiencing chronic fatigue lasting longer than six months, which may be related to babesiosis [7][9] Medical Implications - Babesiosis is a serious tick-borne disease that can co-occur with Lyme disease and may be life-threatening for immunocompromised and elderly individuals [3][10] - There is a hypothesis that persistent Babesia infection may contribute to chronic fatigue, potentially affecting millions of Americans who are undiagnosed [4][8] - The company is conducting clinical trials to test the efficacy of ARAKODA (tafenoquine) in treating babesiosis, although it is currently only approved for malaria prophylaxis [12][13] Company Background - 60 Degrees Pharmaceuticals, Inc. was founded in 2010 and specializes in developing new medicines for infectious diseases [14] - The company achieved FDA approval for its lead product, ARAKODA, in 2018 for malaria prevention and collaborates with research organizations in multiple countries [14]

Core Insights - 60 Degrees Pharmaceuticals is addressing the rising threat of babesiosis, a tick-borne disease, through participation in the Healing Lyme Summit [1][2][4] - The company is conducting two active clinical trials to evaluate the efficacy and safety of tafenoquine for treating severe babesiosis [3][6] Company Overview - 60 Degrees Pharmaceuticals, founded in 2010, focuses on developing treatments for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [6] - The company collaborates with research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private investors [6] Industry Context - Babesiosis is increasingly recognized as a significant public health threat, often co-occurring with Lyme disease, yet awareness and clinical recognition remain limited [2][4] - The Healing Lyme Summit, taking place from April 15–21, 2025, aims to enhance understanding and response to tick-borne illnesses through scientific discussions and educational content [4]

Core Viewpoint - 60 Degrees Pharmaceuticals has signed a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to develop and commercialize tafenoquine for treating and preventing babesiosis, a tick-borne disease [1][2][3] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 [18] - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and is headquartered in Washington D.C. [18] Tafenoquine Development - Tafenoquine is currently not approved by the FDA for babesiosis treatment or prevention, but the agreement with Yale aims to advance its development [2][6] - The drug has shown promise as a next-generation therapeutic for babesiosis, which has limited treatment options for patients with advanced symptoms [3][4] - The clinical trial (NCT06207370) sponsored by 60 Degrees is evaluating tafenoquine's efficacy and safety in treating severe babesiosis, with enrollment ongoing at multiple U.S. sites [5] Babesiosis Context - Babesiosis is caused by the Babesia parasite and transmitted by black-legged ticks, with a significant risk for elderly and immunocompromised patients [4] - An estimated 10% of Lyme disease patients may be coinfected with Babesia, indicating a substantial patient population that could benefit from tafenoquine if approved [4] Clinical Trial Details - The clinical trial is randomized, double-blind, and placebo-controlled, focusing on the time to sustained clinical resolution and molecular cure as primary endpoints [5] - The trial aims to recruit between 24 to 33 patients before conducting an interim analysis [5]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenues and gross profit for the fiscal year 2024, driven by increased sales of ARAKODA, while also facing higher operating expenses and net losses attributable to common shareholders [1][4]. Financial Highlights - FY 2024 net product revenues increased 140% to $607.6 thousand from $253.6 thousand in FY 2023 [4]. - FY 2024 gross profit improved to approximately $222.8 thousand, a turnaround from a gross loss of approximately $221 thousand in FY 2023 [4]. - Operating expenses rose to approximately $10.0 million in FY 2024, up from approximately $4.9 million in FY 2023, primarily due to non-recurring R&D charges [4]. - Net loss attributable to common shareholders was approximately $8.43 million, or $18.55 per share, compared to a net loss of approximately $3.925 million, or $59.18 per share in FY 2023 [4]. Recent Business Highlights - The company submitted a regulatory discretion request to the FDA in December 2024 for the importation of Kodatef, which was granted in February 2025, ensuring continuous supply of ARAKODA in the U.S. [4]. - The company is completing validation of two additional lots of ARAKODA for release into the supply chain by early Q2 2025 [4]. - A randomized evaluation of tafenoquine versus placebo in hospitalized patients with babesiosis commenced in 2024, with interim analysis expected in Q1 2026 [4]. - An open label evaluation of Arakoda in immunosuppressed patients with relapsing/persistent babesiosis began in Q1 2025, with plans to enroll up to 15 patients [4]. - The company completed an epidemiological study on the incidence of babesiosis, with results to be submitted to a peer-reviewed journal [4].

Regulatory Approvals and Clinical Trials - The company has successfully achieved regulatory approval for Arakoda, a malaria preventative treatment, which has been on the market since late 2019[21]. - The FDA authorized the importation of Kodatef from Australia to cover potential disruptions of Arakoda in the U.S. market due to robust demand[47]. - An Investigational Review Board (IRB) approved a Phase II clinical study to evaluate the efficacy and safety of Tafenoquine for chronic babesiosis, with patient enrollment expected to begin in Q3 2025[48]. - The first patient has been enrolled in an expanded access clinical study for persistent babesiosis, confirming the activity of Tafenoquine in patients who have failed standard treatment[49]. - The company entered into a clinical trial agreement with Brigham and Women's Hospital to evaluate tafenoquine for hospitalized babesiosis patients, addressing a critical unmet medical need[51]. - The company is planning three clinical trials for Tafenoquine in babesiosis, with the first patient randomized on June 25, 2024, and interim analysis expected by January 31, 2026[99]. - The FDA has requested a new design for a pediatric malaria prophylaxis study, with an estimated cost of $2 million and a potential start date in Q2 2026[108]. - The FDA requires completion of preclinical laboratory tests and animal studies before human clinical trials can begin[134]. - An IND must be submitted to the FDA, which includes preclinical test results and plans for clinical trials, and there is a 30-day waiting period before trials can commence[137]. - Clinical trials are conducted in four phases, with Phase 1 focusing on safety and dosage, Phase 2 on efficacy and safety risks, Phase 3 on large-scale efficacy and safety evaluation, and Phase 4 on post-approval studies[146]. Financial Activities and Market Research - On February 5, 2025, the company sold 300,700 shares of common stock at a purchase price of $3.575 per share, raising net proceeds of $908,627[27][36]. - The company also sold 204,312 shares of common stock at a purchase price of $5.105 per share on January 28, 2025, raising net proceeds of approximately $804,346[37][46]. - In September 2024, the company entered into a securities purchase agreement for the sale of an aggregate of 1,739,133 shares of Common Stock through Pre-Funded Warrants and Series A and B Warrants[54][55]. - The company conducted market research indicating that the total U.S. market for malaria prevention therapies represents around 1.1 million prescriptions, with an accessible market for ARAKODA estimated at about 330,000 prescriptions[61]. - The company is repositioning tafenoquine for the treatment of chronic tick-borne disease (babesiosis), estimating a potential addressable market of 375,000 cases in the U.S.[62]. - The company is conducting market assessments for babesiosis, including qualitative interviews and plans for quantitative research in Q2 2025[92]. - The total operating expense for the development of Arakoda was less than $10 million, showcasing the company's ability to achieve clinical milestones cost-effectively[88]. Product Development and Pipeline - The company's pipeline includes development programs for vector-borne, fungal, and viral diseases, utilizing products such as Tafenoquine and Celgosivir[21]. - The company is evaluating tafenoquine for potential utility in fungal and viral diseases, including Dengue and RSV, which have significant global and U.S. hospitalization rates[70]. - The company has entered into a cooperative research and development agreement with the U.S. Army to complete the development of Arakoda (Tafenoquine) for malaria prevention, with a new drug application submitted to the FDA in 2018[78]. - Arakoda was approved by the FDA and Australia's Therapeutic Goods Administration in 2018 for malaria prevention, featuring convenient once-weekly dosing and good tolerability[80]. - Tafenoquine has shown potential in treating Candida infections, with 50,000 reported cases of candidiasis annually in the U.S., and could become a market-leading therapy for C. auris[74]. - The company is focused on developing treatments that utilize Tafenoquine, with multiple patents pending for its use in various infectious diseases[115]. Intellectual Property and Patents - The company holds exclusive worldwide licenses for Tafenoquine and has submitted patent applications for its use in various diseases, including COVID-19 and fungal infections[111]. - The company holds multiple patents related to the treatment of Dengue and Malaria, with several patents expiring in 2034 and 2035, indicating a strong pipeline in infectious disease therapeutics[112][114]. - The US patent for the treatment of human coronavirus infections is set to expire on February 19, 2041, showcasing the company's focus on addressing viral infections[115]. - The patent for the novel dosing regimens of Celgosivir for Dengue treatment has an estimated expiration in 2034, reflecting ongoing innovation in antiviral therapies[112]. - The patent portfolio includes treatments for Zika virus infections, with patents expiring in May 2037, indicating diversification in viral infection therapeutics[115]. - The anticipated expiration of several patents in 2041 suggests a long-term strategy for maintaining a competitive edge in the pharmaceutical market[116]. Sales and Marketing Strategies - A nine-month promotional pilot for ARAKODA® (tafenoquine) was launched to increase awareness and sales among healthcare providers and patients[52]. - The company plans to focus on increasing sales of Arakoda, conducting clinical trials for new indications, and repositioning small molecule therapeutics with good safety profiles[90]. - A new Chief Commercial Officer was hired in February 2024 to lead efforts in reintroducing Arakoda and planning new products for tick-borne diseases[92]. - The Arakoda commercial pilot program will start on March 17, 2025, aiming to increase awareness, drive trial and usage, and facilitate access and affordability[95]. - The company plans to relaunch Arakoda for malaria prevention in the United States in 2025[126]. Regulatory Compliance and FDA Processes - The FDA aims to review most NDAs within ten months and priority review applications within six months from the date of filing[150]. - Pre-approval inspections of manufacturing facilities are conducted by the FDA to ensure compliance with cGMP requirements before NDA approval[151]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to ensure the benefits of a product outweigh its risks[152]. - Fast-track, breakthrough therapy, and priority review designations are available for products addressing unmet medical needs, potentially expediting the review process[154]. - The FDA conducts a preliminary review of an NDA within 60 days and may request additional information before accepting it for substantive review[150]. - Companies must submit progress reports detailing clinical trial results at least annually to the FDA[147]. - The FDA may refer an application for a novel drug to an advisory committee for evaluation and recommendations[153]. Royalties and Financial Obligations - The company is obligated to pay royalties at a rate of 1.5% of gross sales under the 2014 NUS-SHS Agreement[119]. - The company will pay a minimum annual royalty of 3% of net sales for net sales under $35 million, and 5% for net sales exceeding $35 million under the U.S. Army Agreement[120]. - The company will pay Knight a royalty equal to 3.5% of net sales until July 12, 2033, or the conversion of all Series A Preferred Stock[124]. - The company is required to pay a sales-based milestone fee of $75,000 once cumulative net sales exceed $6 million under the U.S. Army Agreement[120]. - The company has a minimum annual royalty payment of $15,000 for the 2016 NUS-SHS Agreement in 2023[121].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. announced a 1-for-5 reverse stock split to comply with Nasdaq's minimum bid price requirement of $1.00 for maintaining its listing [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert five current shares into one new share, effective February 24, 2025 [1][4]. - The new CUSIP number for the Common Stock post-split will be 83006G401 [1]. - No fractional shares will be issued; all fractions will be rounded up to the next whole share [5]. Group 2: Compliance and Approval - The reverse stock split was approved by stockholders on November 6, 2024, with the Board of Directors authorized to determine the exact ratio [3]. - The Board approved the 1-for-5 ratio on February 10, 2025, and filed the necessary amendment on February 18, 2025 [3]. Group 3: Company Overview - 60 Degrees Pharmaceuticals, Inc. focuses on developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [7]. - The company collaborates with research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private investors [7].