Core Insights - 60 Degrees Pharmaceuticals, Inc. plans to expand its sales and marketing initiatives for ARAKODA® following positive results from a 6-month commercial pilot that indicated increased market demand among prescribers [1][2][3] Sales and Marketing Initiatives - The company will enhance its integrated digital marketing campaign to improve awareness and engagement with prescribers [2] - The number of inside sales representatives will be increased to strengthen outreach and provider relationships [8] - A partnership with GoodRx will be established to provide broader visibility of ARAKODA offers, facilitating access to savings information for patients and prescribers [8] Clinical Development - The company will add at least two clinical sites for ongoing studies related to babesiosis treatment, responding to FDA feedback regarding its Breakthrough Therapy Designation request [3][4] - The FDA acknowledged that babesiosis meets the criteria for being classified as a serious disease, suggesting the company resubmit its request with data from ongoing clinical trials [3] Product Information - ARAKODA® (tafenoquine) is approved for malaria prophylaxis in the U.S. and has been assessed for safety in five randomized trials lasting up to six months [5][6][20] - Tafenoquine offers potential advantages in less-frequent dosing for malaria prophylaxis due to its long terminal half-life of approximately 16 days [10]

Core Insights - 60 Degrees Pharmaceuticals, Inc. has initiated patient enrollment for the B-FREE Chronic Babesiosis Study, the first of its kind to evaluate a therapeutic for chronic babesiosis, which is expected to run for approximately 12 months [1][5][7] Study Overview - The B-FREE Chronic Babesiosis Study (NCT06656351) is a Phase 2 open-label study assessing the efficacy and safety of the ARAKODA® regimen of tafenoquine over 90 days for patients with chronic babesiosis [2][6] - Chronic babesiosis is characterized by disabling fatigue lasting at least six months, with laboratory confirmation of Babesia parasite exposure within the last year [3][4] - The study aims to confirm Babesia infection using validated molecular tests, potentially revealing a patient population size that could range from 4,400 to 190,000 cases annually in the U.S. [4][7] Treatment Details - The primary endpoint of the study is the resolution of fatigue, measured at Day 90 compared to baseline, using a patient-reported outcome measure [6][7] - The treatment regimen involves self-administering tafenoquine (2 x 100 mg tablets) orally with food for a total of 12 weeks [6][7] Market Need - There is currently no FDA-approved treatment for babesiosis, highlighting a significant unmet medical need [4][15] - The incidence of babesiosis is rising, particularly in the Northeast U.S., with estimates suggesting at least 25,000 cases annually, though the true number may be much higher [15][30] Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and achieved FDA approval for ARAKODA® (tafenoquine) for malaria prevention in 2018 [30][18] - The company collaborates with research and academic organizations in the U.S. and Australia, and is headquartered in Washington, D.C. [30]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenue for Q3 2025, alongside challenges in gross profit due to inventory write-offs and increased operating expenses [6][7]. Financial Highlights for Q3 2025 - Net product revenue increased by 223% year-over-year to $438 thousand [6]. - Gross profit decreased from $24 thousand to a loss of $100 thousand due to a one-time inventory write-off [6][7]. - Operating expenses rose to approximately $2.32 million, up from $2.16 million in Q3 2024, primarily due to increased advertising and sales promotion costs [7]. - Net loss attributable to common shareholders was approximately $2.44 million, or ($0.66) per share, compared to a net loss of approximately $2.27 million, or ($4.65) per share in Q3 2024 [7]. Business Highlights for Q3 2025 - ARAKODA® pharmacy deliveries increased by 14% from 1,319 boxes in Q3 2024 to 1,505 boxes in Q3 2025 [7]. - The company announced its intention to seek a Minor Use Minor Species (MUMS) designation from the FDA for treating acute canine babesiosis [7]. - A nationwide survey determined the total addressable market (TAM) for Babesiosis treatment to be up to $1.1 billion through patent expiration in 2035 [7]. - The company entered a sponsored research agreement with Tulane University to evaluate tafenoquine's activity against Borrelia and Bartonella bacteria [7]. - A partnership was established with the Icahn School of Medicine at Mount Sinai for a planned Phase II clinical study of tafenoquine in treating chronic babesiosis [7].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, showcasing its focus on developing new medicines for vector-borne diseases [1][2]. Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne diseases, with its lead product ARAKODA® (tafenoquine) approved by the U.S. FDA for malaria prevention in 2018 [3]. - ARAKODA is commercially available in the U.S. and Australia, and the company collaborates with prominent research and academic organizations in both countries [3]. Conference Details - Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, will present live on September 10 at 2:30 ET, and management will conduct one-on-one meetings during the conference [2]. - Attendees can request meetings with management through the conference portal or directly with the company [2].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, showcasing its focus on developing new medicines for vector-borne diseases [1][2]. Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne diseases, with its lead product ARAKODA® (tafenoquine) approved by the U.S. FDA for malaria prevention in 2018 [3]. - ARAKODA is commercially available in the U.S. and Australia, and the company collaborates with prominent research and academic organizations in both countries [3]. Conference Participation - Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, will present live on September 10 at 2:30 ET, and the company management will conduct one-on-one meetings during the conference [2]. - Attendees can request meetings with management through the conference portal or directly with the company [2]. Webcast Information - A live webcast of the presentation will be available, with a replay accessible for approximately 90 days on the company's investor page [3].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has initiated a Phase II clinical trial for tafenoquine (ARAKODA®) to treat chronic babesiosis, collaborating with the Icahn School of Medicine at Mount Sinai [1][5]. Company Overview - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for ARAKODA® for malaria prevention in 2018 [21]. - The company is headquartered in Washington, D.C., and has a subsidiary in Australia, focusing on novel therapies for unmet medical needs [21]. Clinical Trial Details - The Phase II open-label study (NCT06656351) will assess the efficacy and safety of tafenoquine over a 90-day period in patients with chronic babesiosis, defined by disabling fatigue lasting at least six months [2][3]. - The primary endpoint is the resolution of fatigue, measured at Day 90 using a patient-reported outcome measure [3]. - Enrollment for the trial is expected to begin in Q4 2025, with completion anticipated by Q2 2026 [9]. Background on Babesiosis - Babesiosis is a tick-borne illness caused by Babesia parasites, leading to symptoms such as fever, chills, and debilitating fatigue, particularly affecting the elderly and immunosuppressed [6]. - The incidence of babesiosis is rising, especially in the Northeast United States, and there are currently no FDA-approved treatments for chronic babesiosis [6][9]. Tafenoquine (ARAKODA®) Information - Tafenoquine is currently approved for malaria prophylaxis but has not been proven effective for treating babesiosis [4][7]. - The drug was discovered by the Walter Reed Army Institute of Research and was approved in the U.S. in 2018, with commercial availability starting in 2019 [8].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported a decline in net product revenues for Q2 2025 but achieved increased profitability due to a shift in distribution strategy and cash-pay patients utilizing KODATEF® [2][6] Financial Highlights - Q2 2025 net product revenues decreased by 19% year-over-year, from $125 thousand in Q2 2024 to $101 thousand in Q2 2025, attributed to a 17% decrease in ARAKODA pharmacy deliveries [7] - Gross profit for Q2 2025 was approximately $51 thousand, up from $35 thousand in Q2 2024, primarily due to lower overall cost of sales and sales of KODATEF 16-count boxes [7] - Operating expenses were approximately $1.86 million in Q2 2025, significantly lower than $4.22 million in Q2 2024, due to the absence of one-off, non-cash R&D costs [7] - Net loss attributable to common shareholders in Q2 2025 was approximately $1.84 million, or ($1.25) per share, compared to a net loss of approximately $4.29 million, or ($21.12) per share in Q2 2024, representing a $2.45 million decrease in loss [7] - The company had $1.97 million in cash on hand as of June 30, 2025, and expects to remain financially viable through March 31, 2026, assuming no additional capital is raised [7] Business Highlights - The company specializes in developing and marketing new medicines for infectious diseases, with FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention achieved in 2018 [5] - A new 8-count bottle format of ARAKODA was introduced to reduce costs for short-term travelers to malaria-endemic regions [7] - The total addressable U.S. market for ARAKODA for human babesiosis may approach $1.1 billion over the remaining 10-year patent life, with annual incidence of babesiosis estimated between 25,000 and 380,000 cases [7] - The company is conducting a hospitalized babesiosis study and aims to complete interim analysis before the end of the 2025 tick season [3][7]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has successfully closed a public offering of 2,631,578 shares of common stock at a price of $1.90 per share, raising total gross proceeds of $5 million, which will be used for working capital and general corporate purposes [1][3]. Group 1: Offering Details - The public offering included Series A-1 warrants and short-term Series A-2 warrants, both with an exercise price of $1.90 per share [2]. - The Series A-1 warrants are exercisable upon issuance and expire five years thereafter, while the Series A-2 warrants expire in 18 months [2]. - The potential additional gross proceeds from the Series A-2 warrants, if fully exercised, could amount to approximately $5 million [3]. Group 2: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [6]. - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private institutional investors [6]. - The company is headquartered in Washington D.C. and has a majority-owned subsidiary in Australia [6].

Core Points - 60 Degrees Pharmaceuticals, Inc. has introduced a new 8-count bottle format for ARAKODA® (tafenoquine), aimed at patients traveling to malaria-endemic areas for shorter durations [1][2] - The new packaging option enhances accessibility for healthcare professionals prescribing ARAKODA for malaria prevention during trips of one week or less [2] - ARAKODA is the only weekly prophylactic therapy that protects against all stages of malaria for individuals aged 18 and older [3][4] Product Information - Tafenoquine, the active ingredient in ARAKODA, was discovered by the Walter Reed Army Institute of Research and received FDA approval for malaria prophylaxis in 2018 [4] - ARAKODA is available as a prescription-only medication and is distributed through pharmaceutical wholesaler networks in the U.S. and Australia [4] - The dosing regimen includes a loading phase of 2 x 100 mg tablets once daily for three days before travel, followed by 2 x 100 mg tablets weekly during travel, and 2 x 100 mg in the week following travel [4] Safety Information - ARAKODA is contraindicated in patients with G6PD deficiency, a history of psychotic disorders, or known hypersensitivity to tafenoquine [6][9] - The drug may cause serious adverse reactions, including hemolytic anemia and methemoglobinemia, necessitating monitoring and appropriate therapy [8][11] - Common adverse reactions reported include headache, dizziness, and gastrointestinal issues, with a notable incidence of psychiatric effects in susceptible individuals [11] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and marketing new medicines for infectious diseases, with a focus on malaria prevention [14] - The company was founded in 2010 and has received support from the U.S. Department of Defense and private investors [14] - The headquarters is located in Washington D.C., with a majority-owned subsidiary in Australia [14]

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].